{"id":23011,"date":"2023-05-23T17:09:18","date_gmt":"2023-05-23T11:39:18","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=23011"},"modified":"2023-05-23T17:09:19","modified_gmt":"2023-05-23T11:39:19","slug":"pharma-news-for-abbvie-oculis-astrazeneca","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-abbvie-oculis-astrazeneca","title":{"rendered":"FDA Approves RINVOQ for Crohn&#8217;s Disease; FDA Approves Krystal Biotech\u2019s Gene Therapy Vyjuvek; FDA Approves EPKINLY to Treat R\/R DLBCL; FDA Orphan Drug Designation to Mitazalimab; Phase 3 Trial Result of OCS-01 Eye Drops; TAGRISSO\u00ae + Chemotherapy for the EGFR-mutated Advanced Lung Cancer"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_76 counter-hierarchy ez-toc-counter ez-toc-white ez-toc-container-direction\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<label for=\"ez-toc-cssicon-toggle-item-69f08578d98ac\" class=\"ez-toc-cssicon-toggle-label\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/label><input type=\"checkbox\"  id=\"ez-toc-cssicon-toggle-item-69f08578d98ac\"  aria-label=\"Toggle\" \/><nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-abbvie-oculis-astrazeneca\/#FDA_Approves_RINVOQ_as_a_Once-Daily_Pill_for_Moderately_to_Severely_Active_Crohns_Disease\" >FDA Approves RINVOQ as a Once-Daily Pill for Moderately to Severely Active Crohn&#8217;s Disease<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-abbvie-oculis-astrazeneca\/#FDA_Approves_Krystal_Biotechs_Gene_Therapy_Vyjuvek_for_Dystrophic_Epidermolysis_Bullosa\" >FDA Approves Krystal Biotech\u2019s Gene Therapy Vyjuvek for Dystrophic Epidermolysis Bullosa<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-abbvie-oculis-astrazeneca\/#FDA_Approves_EPKINLY_as_the_First_and_Only_Bispecific_Antibody_to_Treat_Adult_Patients_with_RR_DLBCL\" >FDA Approves EPKINLY as the First and Only Bispecific Antibody to Treat Adult Patients with R\/R DLBCL<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-abbvie-oculis-astrazeneca\/#FDA_Grants_Orphan_Drug_Designation_to_Mitazalimab_in_Pancreatic_Cancer\" >FDA Grants Orphan Drug Designation to Mitazalimab in Pancreatic Cancer<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-abbvie-oculis-astrazeneca\/#Oculis_Announces_Positive_Top-Line_Results_from_DIAMOND_Stage_1_Phase_3_Trial_in_Diabetic_Macular_Edema_with_OCS-01_Eye_Drops\" >Oculis Announces Positive Top-Line Results from DIAMOND Stage 1 Phase 3 Trial in Diabetic Macular Edema with OCS-01 Eye Drops<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-abbvie-oculis-astrazeneca\/#TAGRISSO%C2%AE_osimertinib_Chemotherapy_Exhibited_Strong_Improvement_in_Progression-free_Survival_for_Patients_with_EGFR-mutated_Advanced_Lung_Cancer\" >TAGRISSO\u00ae (osimertinib) + Chemotherapy Exhibited Strong Improvement in Progression-free Survival for Patients with EGFR-mutated Advanced Lung Cancer<\/a><\/li><\/ul><\/nav><\/div>\n\n<h2 class=\"wp-block-heading\" id=\"h-fda-approves-rinvoq-as-a-once-daily-pill-for-moderately-to-severely-active-crohn-s-disease\"><span class=\"ez-toc-section\" id=\"FDA_Approves_RINVOQ_as_a_Once-Daily_Pill_for_Moderately_to_Severely_Active_Crohns_Disease\"><\/span><strong>FDA Approves RINVOQ as a Once-Daily Pill for Moderately to Severely Active Crohn&#8217;s Disease<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>AbbVie <\/strong>announced that the FDA had approved <strong>RINVOQ\u00ae (upadacitinib)<\/strong> for treating people with moderately to highly active Crohn&#8217;s disease who have had an unsatisfactory response or intolerance to one or more TNF blockers. This is RINVOQ&#8217;s sixth FDA approval in rheumatology, dermatology, and gastroenterology, which is now indicated in ulcerative colitis and Crohn&#8217;s disease.<\/p>\n\n\n\n<p>Crohn&#8217;s disease is a chronic, systemic disease characterized by inflammation of the gastrointestinal (or digestive) tract, resulting in persistent diarrhea and abdominal pain. It is a progressive disease, which means it worsens over time and, in many cases, necessitates surgery. As <a href=\"https:\/\/www.delveinsight.com\/report-store\/crohns-disease-cd-market\">Crohn&#8217;s disease&#8217;s signs and symptoms<\/a> are unpredictable, it places a considerable burden on those who live with the disease.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>&#8220;AbbVie recognises the need for more Crohn&#8217;s disease treatment options that can help address both rapid symptom relief and visible reduction of intestinal lining damage,&#8221; said <\/em><strong><em>Thomas Hudson, M.D., senior vice president of research and development and chief scientific officer at AbbVie.<\/em><\/strong><em> &#8220;We&#8217;re pleased that RINVOQ may provide this relief and that it is now available to treat Crohn&#8217;s disease.&#8221;<\/em><\/p>\n<\/blockquote>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>&#8220;Symptoms of moderately to severely active Crohn&#8217;s disease can be disruptive and uncomfortable for patients, so getting relief as soon as possible is critical.&#8221; Given the disease&#8217;s progressive nature, the endoscopic response is equally as crucial,&#8221; said <\/em><strong><em>Edward V. Loftus, Jr., M.D., professor of medicine in the division of gastroenterology and hepatology at Mayo Clinic in Rochester, Minnesota, and U-EXCEL research investigator.<\/em><\/strong><em> &#8220;Based on the clinical trial results, treatment with RINVOQ provides both immediate and long-term symptom relief, as well as evidence of a visible reduction in damage to the intestinal lining caused by excess inflammation.&#8221;<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>The <a href=\"https:\/\/www.delveinsight.com\/report-store\/rinvoq-market-drug-insight-and-market-forecast\">RINVOQ approval<\/a> is based on results from two induction trials, <strong>U-EXCEED and U-EXCEL,<\/strong> as well as the U-ENDURE maintenance study. Statistical significance was established for the co-primary objectives and critical secondary endpoints with <strong>RINVOQ 45 mg<\/strong> in the induction studies and RINVOQ 15 mg and 30 mg in the maintenance study when compared to placebo.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"FDA_Approves_Krystal_Biotechs_Gene_Therapy_Vyjuvek_for_Dystrophic_Epidermolysis_Bullosa\"><\/span><strong>FDA Approves Krystal Biotech\u2019s Gene Therapy Vyjuvek for Dystrophic Epidermolysis Bullosa<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Krystal Biotech, Inc.<\/strong> announced that the US Food and Drug Administration (FDA) has approved <strong>VYJUVEKTM (beremagene geperpavec-svdt)<\/strong> for the treatment of dystrophic epidermolysis bullosa (DEB) in patients aged six months and older. VYJUVEK is intended to treat the genetic root cause of DEB by delivering functional copies of the human COL7A1 gene, resulting in wound healing and sustained functional COL7 protein expression with redosing. VYJUVEK is the first and only <a href=\"https:\/\/www.delveinsight.com\/report-store\/dystrophic-epidermolysis-bullosa-market\">FDA-approved drug for the treatment of DEB<\/a>, both recessive and dominant, that can be administered by a healthcare professional in either a healthcare professional setting or at home.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>&#8220;This is a devastating disease,&#8221; stated M. Peter Marinkovich, M.D., the GEM-3 trial&#8217;s principal investigator,<\/em><strong><em> Director of the Blistering Condition Clinic at Stanford Health Care, and Associate Professor of Dermatology at Stanford University School of Medicine. <\/em><\/strong><em>&#8220;Until now, doctors and nurses had no way of preventing blisters and wounds from developing on the skin of dystrophic EB patients, and all we could do was bandage them and helplessly watch as new blisters formed.&#8221; VYJUVEK topical gene therapy alters everything. Because it corrects the underlying skin deficiency of dystrophic EB, VYJUVEK both cures patient wounds and prevents skin from re-blistering. Because it is safe and simple to apply directly to wounds, it does not necessitate a lot of supporting technology or specialized skills, making VYJUVEK extremely accessible even to patients who live distant from specialized centers.&#8221;<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>VYJUVEK was approved by the FDA based on two clinical investigations. The <strong>GEM-I\/II trial<\/strong> was an intra-patient, open-label, single-center, randomized, placebo-controlled study that found that repeat topical applications of VYJUVEK were associated with long-term wound closure, full-length cutaneous COL7 expression, and anchoring fibril assembly with few adverse events. The GEM-3 experiment was an intra-patient, double-blind, multicenter, randomized, placebo-controlled study that fulfilled both its primary and secondary endpoints of full wound healing at six months and three months. VYJUVEK was well tolerated, with no drug-related major adverse events or treatment-related discontinuations.<\/p>\n\n\n\n<p>VYJUVEK will be accessible in the United States in the third quarter of 2023, and the Company will begin marketing it immediately. Krystal Connect, a personalized support program, was designed by the Company to fulfill the needs of patients, carers, and families as they begin and continue their VYJUVEK treatment journey.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"FDA_Approves_EPKINLY_as_the_First_and_Only_Bispecific_Antibody_to_Treat_Adult_Patients_with_RR_DLBCL\"><\/span><strong>FDA Approves EPKINLY as the First and Only Bispecific Antibody to Treat Adult Patients with R\/R DLBCL<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>AbbVie <\/strong>announced that the U.S. Food and Drug Administration (FDA) has given its approval for <strong>EPKINLYTM<\/strong>, the first and only <strong>T-cell engaging bispecific antibody<\/strong>, as a treatment for adult patients with <a href=\"https:\/\/www.delveinsight.com\/report-store\/diffuse-large-b-cell-lymphoma-market\"><strong>relapsed or refractory diffuse large B-cell lymphoma (DLBCL)<\/strong><\/a>. This approval applies to DLBCL cases not otherwise specified, including those arising from <strong>indolent lymphoma<\/strong>, and <a href=\"https:\/\/www.delveinsight.com\/report-store\/b-cell-lymphomas-market\"><strong>high-grade B-cell lymphoma<\/strong><\/a>, after two or more rounds of systemic therapies. <strong>EPKINLY <\/strong>has been granted approval under the FDA&#8217;s Accelerated Approval program based on its response rate and durability of response. However, the continued approval for this indication may be subject to verification and description of clinical benefits in confirmatory trials. The development of EPKINLY is a collaborative effort between AbbVie and Genmab as part of their oncology partnership.<\/p>\n\n\n\n<p>DLBCL is an aggressive type of <a href=\"https:\/\/www.delveinsight.com\/report-store\/non-hodgkins-lymphoma-nhl-market\"><strong>non-Hodgkin&#8217;s lymphoma<\/strong><\/a> characterized by fast growth and affecting <strong>B cells <\/strong>in the <strong>lymphatic system<\/strong>. It is the most common form of non-Hodgkin&#8217;s lymphoma, with an estimated <strong>30,400 cases<\/strong> in the <strong>United States<\/strong> in <strong>2022 <\/strong>and <strong>150,000 new cases<\/strong> worldwide annually. DLBCL patients are typically treated with chemoimmunotherapy-based regimens, but options for patients who have relapsed or are refractory to current therapies are limited. Recent advancements in targeted therapies, including <strong>T-cell-mediated treatments<\/strong>, have emerged as potential options for these patients.<\/p>\n\n\n\n<p>AbbVie is dedicated to transforming standards of care for <strong>blood cancers<\/strong> and advancing cancer research and treatment. EPKINLY is the third approved blood cancer treatment in AbbVie&#8217;s growing oncology portfolio, reflecting their commitment to making a significant impact on the lives of people living with cancer.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"FDA_Grants_Orphan_Drug_Designation_to_Mitazalimab_in_Pancreatic_Cancer\"><\/span><strong>FDA Grants Orphan Drug Designation to Mitazalimab in Pancreatic Cancer<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Alligator Biosciences<\/strong>, a drug developer, has announced that the U.S. The Food and Drug Administration has granted orphan drug designation to <strong>mitazalimab <\/strong>for its potential use as a therapeutic option in patients with<strong> <\/strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/pancreatic-cancer-market\"><strong>pancreatic cancer<\/strong><\/a>. Mitazalimab is a monoclonal antibody that targets <strong>CD40 <\/strong>and is designed to sensitize tumors to chemotherapy and stimulate immune-mediated cell death by activating dendritic cells, B cells, and macrophages. Its safety and effectiveness, in combination with modified FOLFIRINOX, are currently being evaluated in treatment-na\u00efve patients with metastatic pancreatic ductal adenocarcinoma as part of the <strong>OPTIMIZE-1 trial, a phase 2 multicenter study<\/strong>.<\/p>\n\n\n\n<p>S\u00f8ren Bregenholt, the CEO of Alligator Bioscience, expressed his excitement over the orphan drug designation, considering it a significant milestone for mitazalimab, which has shown promising clinical results in its <strong>phase 2 trial<\/strong> for pancreatic cancer. Bregenholt explained that the orphan designation provides important benefits, such as cost savings during development and marketing exclusivity following approval, and he is pleased to see the potential of mitazalimab being recognized through this designation.<\/p>\n\n\n\n<p>In <strong>January 2023<\/strong>, Alligator Biosciences reported positive interim data from the <strong>OPTIMIZE-1 trial<\/strong>, indicating that the addition of mitazalimab to mFOLFIRINOX resulted in an <strong>objective response rate (ORR) <\/strong>of <strong>52% <\/strong>and a disease control rate of over<strong> 90%<\/strong> in <strong>23 evaluable patients<\/strong>, based on <strong>RECIST v1.1 criteria<\/strong>. Furthermore, the combination treatment was found to be safe and well-tolerated at the recommended dose of <strong>900 \u03bcg\/kg <\/strong>during the <strong>phase 1b dose-escalation phase of the trial<\/strong>.<\/p>\n\n\n\n<p>The early efficacy findings from the <strong>OPTIMIZE-1 trial<\/strong> are promising when compared to the results of a previous <strong>phase 3 trial (NCT00112658)<\/strong>, where <strong>FOLFIRINOX <\/strong>alone achieved an <strong>ORR<\/strong> of <strong>31.6%<\/strong> as a frontline therapy for patients with <a href=\"https:\/\/www.delveinsight.com\/report-store\/metastatic-pancreatic-cancer-mpc-market\"><strong>metastatic pancreatic cancer<\/strong><\/a>.<\/p>\n\n\n\n<p>Alligator Biosciences announced in <strong>April 2023<\/strong> that the OPTIMIZE-1 trial had been fully enrolled. To be eligible for the study, patients had to be at least <strong>18 years old<\/strong>, have a diagnosis of previously untreated <a href=\"https:\/\/www.delveinsight.com\/report-store\/pancreatic-ductal-adenocarcinoma-market\"><strong>metastatic pancreatic ductal adenocarcinoma<\/strong><\/a>, and have a life expectancy of at least <strong>3 months<\/strong>. Patients were also required to have acceptable hematologic and clinical chemistry laboratory values and should not have received prior chemotherapy or abdominal radiotherapy.<\/p>\n\n\n\n<p>The primary endpoints of the OPTIMIZE-1 trial are the frequency of dose-limiting toxicities and the ORR. Secondary endpoints include progression-free survival, overall survival, and safety, among others.<\/p>\n\n\n\n<p>Additional interim data, including results on progression-free survival, are expected in mid-2023, and full topline data are anticipated in the first quarter of 2024. These data, combined with the orphan drug designation, will facilitate ongoing discussions with the FDA regarding further clinical development and the approval pathway for mitazalimab in the treatment of pancreatic cancer.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Oculis_Announces_Positive_Top-Line_Results_from_DIAMOND_Stage_1_Phase_3_Trial_in_Diabetic_Macular_Edema_with_OCS-01_Eye_Drops\"><\/span><strong>Oculis Announces Positive Top-Line Results from DIAMOND Stage 1 Phase 3 Trial in Diabetic Macular Edema with OCS-01 Eye Drops<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On May 22, 2023, Oculis Holding AG (Nasdaq: OCS) (\u201cOculis\u201d) announced positive top-line results from Stage 1 of its Phase 3 DIAMOND trial of OCS-01 <a href=\"https:\/\/www.delveinsight.com\/report-store\/diabetic-macular-edema-dme-pipeline-insight\"><strong>eye drops in Diabetic Macular Edema (DME)<\/strong><\/a>. OCS-01 Positive Phase 3 Stage 1 Top Line Results Could Signify a Paradigm Shift in Diabetic Macular Edema Treatment.<\/p>\n\n\n\n<p>DIAMOND (DIAbetic Macular edema patients ON a Drop) is a Phase 3, two-stage, double-masked, randomized, multicenter trial to assess the efficacy and safety of OCS-01 eye drops in DME patients. The primary objective of Stage 1 was to select the optimal dosing regimen. Stage 1 was conducted in 39 sites across the USA and Europe, with 148 patients randomized 2:1 to receive OCS-01 (n=100) or vehicle (n=48) six times daily for a six-week loading phase and then three times daily for a subsequent six-week maintenance phase.<\/p>\n\n\n\n<p>OCS-01, in this 3-month trial, has met both clinical efficacy endpoints (main BCVA change, proportion of patients with 3 lines gain) that are required for regulatory approval, if met at 12 months treatment duration. OCS-01 was well-tolerated, with no unexpected adverse events observed. The OCS-01 development program will continue as planned with Stage 2 which includes two global trials, each enrolling approximately 350\u2013450 patients. Oculis expects to begin Stage 2 of the DIAMOND trial in the second half of this year.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p>I am pleased and very encouraged that in Stage 1 of this trial, OCS-01 has met both primary and secondary endpoints in a robust and statistically significant manner. A topical agent has never demonstrated a positive result in DME. Now, OCS-01 has been validated in two different studies with consistent and repeated positive results. We remain focused on advancing with high priority the DIAMOND Phase 3 trial to Stage 2. This important milestone has the potential to bring us one step closer to providing the first treatment in the form of eye drops to patients with DME which is a devastating and blinding disease.<\/p>\n<cite><strong>Riad Sherif, M.D., CEO of Oculis<\/strong><\/cite><\/blockquote>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p>The mechanism of DME involves both increased permeability and inflammation. Current anti-VEGFs are effective as anti-permeability agents but have no effect on inflammation. Therefore, a significant proportion of patients are sub-optimally treated with anti-VEGFs alone. If approved, OCS-01 has the potential to complement current treatment and address recalcitrant patients. Furthermore, since it is a topical agent, it has also the potential to be a first line treatment in DME, if approved. In short, I believe the impact of OCS-01 in DME could be a true game-changer.<\/p>\n<cite>David S. Boyer, M.D., Adjunct Clinical Professor of Ophthalmology, Keck School of Medicine, University of Southern California, Los Angeles and Co-Principal Investigator for the DIAMOND trial<\/cite><\/blockquote>\n\n\n\n<p>As per DelveInsight, Diabetic Macular Edema is the leading cause of visual loss and legal blindness in patients with diabetes. Globally, about 37 million people worldwide, with a significant number of patients left untreated due to a lack of convenient treatment options. Among the 7MM, the total <a href=\"https:\/\/www.delveinsight.com\/report-store\/diabetic-macular-edema-dme-epidemiology-forecast\"><strong>prevalent cases of Diabetic Macular Edema (DME)<\/strong><\/a> were the highest in the US\u00a0 in 2021, with more than 1 million cases, and lowest in France with 60,000 cases. Moreover, Japan accounted for approximately 194,000 cases in 2019, which is nearly 11% of the total DME prevalent cases in the 7MM. The <a href=\"https:\/\/www.delveinsight.com\/report-store\/diabetic-macular-edema-dme-market\"><strong>rising cases of Diabetic Macular Edema<\/strong><\/a> are driving the demand for effective and safe vaccines. The emerging pipeline therapies, anticipated high hope for better treatment scenarios in the coming years.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"TAGRISSO%C2%AE_osimertinib_Chemotherapy_Exhibited_Strong_Improvement_in_Progression-free_Survival_for_Patients_with_EGFR-mutated_Advanced_Lung_Cancer\"><\/span><strong>TAGRISSO\u00ae (osimertinib) + Chemotherapy Exhibited Strong Improvement in Progression-free Survival for Patients with EGFR-mutated Advanced Lung Cancer<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On May 17, 2023, AstraZeneca announced FLAURA2 Phase III trial result for TAGRISSO\u00ae (osimertinib) plus chemotherapy demonstrated strong improvement in progression-free survival for patients with epidermal growth factor receptor-mutated (EGFRm) advanced lung cancer. TAGRISSO\u00ae (osimertinib) in combination with chemotherapy demonstrated a statistically significant and clinically meaningful result compared to TAGRISSO alone for patients with locally advanced (Stage IIIB-IIIC) or <a href=\"https:\/\/www.delveinsight.com\/report-store\/epidermal-growth-factor-receptor-non-small-cell-lung-cancer-market\"><strong>metastatic (Stage IV) EGFRm Non-small cell lung cancer (NSCLC)<\/strong><\/a>.&nbsp;<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>As the global standard of care for EGFR-mutated non-small cell lung cancer, osimertinib monotherapy has transformed the treatment landscape, allowing many patients the opportunity to achieve improved survival. FLAURA2 provides compelling evidence that the addition of chemotherapy to osimertinib can provide a new option for patients and clinicians that further improves outcomes compared to osimertinib alone and, as such, can further delay treatment resistance and disease progression.\u00a0<\/em><\/p>\n<cite>Pasi A. J\u00e4nne, MD, PhD, medical oncologist at Dana-Farber Cancer Institute and principal investigator for the FLAURA2 trial,<\/cite><\/blockquote>\n\n\n\n<p><\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>These significant FLAURA2 results show TAGRISSO has the potential to offer patients in the first-line setting a new treatment option that can extend the time they live without their disease progressing. This meaningfully builds on successive trials demonstrating improved clinical benefit with TAGRISSO in patients with EGFR-mutated lung cancer.<\/em><\/p>\n<cite>Susan Galbraith, Executive Vice President, Oncology R&amp;D, AstraZeneca<\/cite><\/blockquote>\n\n\n\n<p>Safety results and discontinuation rates due to adverse events were consistent with the established profiles of each medicine. At the time of this analysis, the overall survival (OS) data were immature and will be formally assessed at a subsequent analysis. As per the update, AstraZeneca is expected to present data at a forthcoming medical meeting and shared it with global health authorities.<\/p>\n\n\n\n<p>As part of AstraZeneca\u2019s ongoing commitment to treating patients as early as possible in lung cancer, TAGRISSO is also being investigated in <a href=\"https:\/\/www.delveinsight.com\/report-store\/non-small-cell-lung-carcinoma-nsclc-market\"><strong>unresectable NSCLC<\/strong><\/a> in the pivotal LAURA Phase III trial, with results expected later this year.<\/p>\n\n\n\n<p>About\u00a02.2 million people are diagnosed with lung cancer globally. As per the latest market assessment by DelveInsight, the United States had 227,000+ incident cases of Lung Cancer in 2020, of which ~85%, i.e., 193,694 were <a href=\"https:\/\/www.delveinsight.com\/report-store\/non-small-cell-lung-cancer-market\"><strong>NSCLC cancer patients<\/strong><\/a>. Among the European 5 countries, Germany had the highest cases of NSCLC. Furthermore, Japan accounts for about 117,000+ cases in 2020. Among the 7MM, the highest number of NSCLCs were estimated in the United States. Additionally, about 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia have EGFRm NSCLC.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>FDA Approves RINVOQ as a Once-Daily Pill for Moderately to Severely Active Crohn&#8217;s Disease AbbVie announced that the FDA had approved RINVOQ\u00ae (upadacitinib) for treating people with moderately to highly active Crohn&#8217;s disease who have had an unsatisfactory response or intolerance to one or more TNF blockers. This is RINVOQ&#8217;s sixth FDA approval in rheumatology, [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":23014,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_editorskit_title_hidden":false,"_editorskit_reading_time":9,"_editorskit_is_block_options_detached":false,"_editorskit_block_options_position":"{}","advgb_blocks_editor_width":"","advgb_blocks_columns_visual_guide":"","footnotes":""},"categories":[32],"tags":[56,20713,2077,212,16830,18620,19615,704,20712,349,365,420,6733,979,20714,449,639,5789],"industry":[17225],"therapeutic_areas":[17239,17228,17244],"class_list":["post-23011","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-abbvie","tag-alligator-biosciences","tag-crohns-disease","tag-diabetic-macular-edema","tag-diffuse-large-b-cell-lymphoma","tag-dlbcl","tag-dystrophic-epidermolysis-bullosa","tag-fda","tag-krystal-biotech","tag-latest-pharma-news","tag-lung-cancer","tag-news","tag-non-small-cell-lung-cancer","tag-non-small-cell-lung-cancer-nsclc","tag-oculis","tag-pancreatic-cancer","tag-pharma-news","tag-recent-pharma-news","industry-pharmaceutical","therapeutic_areas-gastroenterology","therapeutic_areas-oncology","therapeutic_areas-ophthalmology"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.8 (Yoast SEO v25.8) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Pharma News | AbbVie, Oculis, AstraZeneca, Krystal Biotech<\/title>\n<meta name=\"description\" content=\"AbbVie&#039;s RINVOQ; Krystal Biotech\u2019s Vyjuvek; AbbVie&#039;s EPKINLY; Alligator Biosciences&#039;s Mitazalimab; Oculis&#039;s OCS-01; AstraZeneca&#039;s TAGRISSO\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-abbvie-oculis-astrazeneca\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pharma News | AbbVie, Oculis, AstraZeneca, Krystal Biotech\" \/>\n<meta property=\"og:description\" content=\"AbbVie&#039;s RINVOQ; Krystal Biotech\u2019s Vyjuvek; AbbVie&#039;s EPKINLY; Alligator Biosciences&#039;s Mitazalimab; Oculis&#039;s OCS-01; AstraZeneca&#039;s TAGRISSO\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-abbvie-oculis-astrazeneca\" \/>\n<meta property=\"og:site_name\" content=\"DelveInsight Business Research\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/DelveInsight-1423323754607782\/\" \/>\n<meta property=\"article:published_time\" content=\"2023-05-23T11:39:18+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2023-05-23T11:39:19+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2023\/05\/23170738\/Pharma-News-for-AbbVie-Oculis-AstraZeneca-Krystal-Biotech-Alligator-Biosciences.png\" \/>\n\t<meta property=\"og:image:width\" content=\"772\" \/>\n\t<meta property=\"og:image:height\" content=\"482\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"DelveInsight\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@DelveInsight\" \/>\n<meta name=\"twitter:site\" content=\"@DelveInsight\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"DelveInsight\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"11 minutes\" \/>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Pharma News | AbbVie, Oculis, AstraZeneca, Krystal Biotech","description":"AbbVie's RINVOQ; Krystal Biotech\u2019s Vyjuvek; AbbVie's EPKINLY; Alligator Biosciences's Mitazalimab; Oculis's OCS-01; AstraZeneca's TAGRISSO","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-abbvie-oculis-astrazeneca","og_locale":"en_US","og_type":"article","og_title":"Pharma News | AbbVie, Oculis, AstraZeneca, Krystal Biotech","og_description":"AbbVie's RINVOQ; Krystal Biotech\u2019s Vyjuvek; AbbVie's EPKINLY; Alligator Biosciences's Mitazalimab; Oculis's OCS-01; AstraZeneca's TAGRISSO","og_url":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-abbvie-oculis-astrazeneca","og_site_name":"DelveInsight Business Research","article_publisher":"https:\/\/www.facebook.com\/DelveInsight-1423323754607782\/","article_published_time":"2023-05-23T11:39:18+00:00","article_modified_time":"2023-05-23T11:39:19+00:00","og_image":[{"width":772,"height":482,"url":"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2023\/05\/23170738\/Pharma-News-for-AbbVie-Oculis-AstraZeneca-Krystal-Biotech-Alligator-Biosciences.png","type":"image\/png"}],"author":"DelveInsight","twitter_card":"summary_large_image","twitter_creator":"@DelveInsight","twitter_site":"@DelveInsight","twitter_misc":{"Written by":"DelveInsight","Est. reading time":"11 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-abbvie-oculis-astrazeneca","url":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-abbvie-oculis-astrazeneca","name":"Pharma News | AbbVie, Oculis, AstraZeneca, Krystal Biotech","isPartOf":{"@id":"https:\/\/www.delveinsight.com\/blog\/#website"},"primaryImageOfPage":{"@id":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-abbvie-oculis-astrazeneca#primaryimage"},"image":{"@id":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-abbvie-oculis-astrazeneca#primaryimage"},"thumbnailUrl":"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2023\/05\/23170738\/Pharma-News-for-AbbVie-Oculis-AstraZeneca-Krystal-Biotech-Alligator-Biosciences.png","datePublished":"2023-05-23T11:39:18+00:00","dateModified":"2023-05-23T11:39:19+00:00","author":{"@id":"https:\/\/www.delveinsight.com\/blog\/#\/schema\/person\/0d96a31a370c143ffdb481d985d7edfd"},"description":"AbbVie's RINVOQ; Krystal Biotech\u2019s Vyjuvek; AbbVie's EPKINLY; Alligator Biosciences's Mitazalimab; Oculis's OCS-01; AstraZeneca's TAGRISSO","inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.delveinsight.com\/blog\/pharma-news-for-abbvie-oculis-astrazeneca"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-abbvie-oculis-astrazeneca#primaryimage","url":"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2023\/05\/23170738\/Pharma-News-for-AbbVie-Oculis-AstraZeneca-Krystal-Biotech-Alligator-Biosciences.png","contentUrl":"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2023\/05\/23170738\/Pharma-News-for-AbbVie-Oculis-AstraZeneca-Krystal-Biotech-Alligator-Biosciences.png","width":772,"height":482,"caption":"Pharma News for AbbVie, Oculis, AstraZeneca, Krystal Biotech, Alligator Biosciences"},{"@type":"WebSite","@id":"https:\/\/www.delveinsight.com\/blog\/#website","url":"https:\/\/www.delveinsight.com\/blog\/","name":"DelveInsight Business Research","description":"Blog","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.delveinsight.com\/blog\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Person","@id":"https:\/\/www.delveinsight.com\/blog\/#\/schema\/person\/0d96a31a370c143ffdb481d985d7edfd","name":"DelveInsight","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.delveinsight.com\/blog\/#\/schema\/person\/image\/","url":"https:\/\/secure.gravatar.com\/avatar\/f9314f22b8c5b61d496451e91f32488d2457ecb59283b7b2ad7e82d330b47aba?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/f9314f22b8c5b61d496451e91f32488d2457ecb59283b7b2ad7e82d330b47aba?s=96&d=mm&r=g","caption":"DelveInsight"}}]}},"author_meta":{"display_name":"DelveInsight","author_link":"https:\/\/www.delveinsight.com\/blog\/author\/arawat"},"featured_img":"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2023\/05\/23170738\/Pharma-News-for-AbbVie-Oculis-AstraZeneca-Krystal-Biotech-Alligator-Biosciences-300x187.png","coauthors":[],"tax_additional":{"categories":{"linked":["<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Notizia - Recent Pharma, Healthcare and Biotech Happenings<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">Notizia - Recent Pharma, Healthcare and Biotech Happenings<\/span>"]},"tags":{"linked":["<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">AbbVie<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Alligator Biosciences<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Crohn\u2019s disease<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Diabetic Macular Edema<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Diffuse Large B Cell Lymphoma<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">DLBCL<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">dystrophic epidermolysis bullosa<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">FDA<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Krystal Biotech<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Latest pharma news<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Lung Cancer<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">news<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Non-small cell lung cancer<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Non-Small Cell Lung Cancer (NSCLC)<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Oculis<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Pancreatic Cancer<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">pharma news<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">recent pharma news<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">AbbVie<\/span>","<span class=\"advgb-post-tax-term\">Alligator Biosciences<\/span>","<span class=\"advgb-post-tax-term\">Crohn\u2019s disease<\/span>","<span class=\"advgb-post-tax-term\">Diabetic Macular Edema<\/span>","<span class=\"advgb-post-tax-term\">Diffuse Large B Cell Lymphoma<\/span>","<span class=\"advgb-post-tax-term\">DLBCL<\/span>","<span class=\"advgb-post-tax-term\">dystrophic epidermolysis bullosa<\/span>","<span class=\"advgb-post-tax-term\">FDA<\/span>","<span class=\"advgb-post-tax-term\">Krystal Biotech<\/span>","<span class=\"advgb-post-tax-term\">Latest pharma news<\/span>","<span class=\"advgb-post-tax-term\">Lung Cancer<\/span>","<span class=\"advgb-post-tax-term\">news<\/span>","<span class=\"advgb-post-tax-term\">Non-small cell lung cancer<\/span>","<span class=\"advgb-post-tax-term\">Non-Small Cell Lung Cancer (NSCLC)<\/span>","<span class=\"advgb-post-tax-term\">Oculis<\/span>","<span class=\"advgb-post-tax-term\">Pancreatic Cancer<\/span>","<span class=\"advgb-post-tax-term\">pharma news<\/span>","<span class=\"advgb-post-tax-term\">recent pharma news<\/span>"]}},"comment_count":"0","relative_dates":{"created":"Posted 3 years ago","modified":"Updated 3 years ago"},"absolute_dates":{"created":"Posted on May 23, 2023","modified":"Updated on May 23, 2023"},"absolute_dates_time":{"created":"Posted on May 23, 2023 5:09 pm","modified":"Updated on May 23, 2023 5:09 pm"},"featured_img_caption":"Pharma News for AbbVie, Oculis, AstraZeneca, Krystal Biotech, Alligator Biosciences","series_order":"","_links":{"self":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/posts\/23011","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/comments?post=23011"}],"version-history":[{"count":0,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/posts\/23011\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/media\/23014"}],"wp:attachment":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/media?parent=23011"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/categories?post=23011"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/tags?post=23011"},{"taxonomy":"industry","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/industry?post=23011"},{"taxonomy":"therapeutic_areas","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/therapeutic_areas?post=23011"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}