{"id":17952,"date":"2022-07-12T20:32:17","date_gmt":"2022-07-12T15:02:17","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=17952"},"modified":"2022-07-12T20:47:17","modified_gmt":"2022-07-12T15:17:17","slug":"pharma-news-for-abbvie-sobi-roche","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-abbvie-sobi-roche","title":{"rendered":"Novo Nordisk\u2019s Concizumab for Hemophilia; AbbVie Ends its Alliance with Alector; ADC Therapeutics and Sobi Enters in Exclusive Licensing Deal; BMS\u2019 Opdivo Gets NHS Use; Merck to Acquire Seagen; FDA Priority Review to Roche\u2019s Lunsumio; AstraZeneca to Acquire TeneoTwo; FDA Orphan Drug Designation to PBI-200"},"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-6a0e2a53364ff\" 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-6a0e2a53364ff\"  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-sobi-roche\/#Novo_Nordisk_Reports_Phase_III_Results_of_Concizumab_Drug_for_Hemophilia_A_or_B\" >Novo Nordisk Reports Phase III Results of Concizumab Drug for Hemophilia A or B<\/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-sobi-roche\/#AbbVie_Pulls_its_Alliance_with_Alector_For_Alzheimers_Disease_Candidate_AL003\" >AbbVie Pulls its Alliance with Alector For Alzheimer\u2019s Disease Candidate AL003<\/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-sobi-roche\/#ADC_Therapeutics_and_Sobi_Enters_in_Exclusive_Licensing_Deal_to_Develop_and_Commercialize_Zynlonta\" >ADC Therapeutics and Sobi Enters in Exclusive Licensing Deal to Develop and Commercialize Zynlonta<\/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-sobi-roche\/#BMS_Opdivo_Gets_NHS_Use_as_Adjuvant_Bladder_Cancer_Treatment\" >BMS\u2019 Opdivo Gets NHS Use as Adjuvant Bladder Cancer Treatment<\/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-sobi-roche\/#AstraZeneca_Signs_USD_13_Billion_Deal_to_Acquire_TeneoTwo\" >AstraZeneca Signs USD 1.3 Billion Deal to Acquire TeneoTwo<\/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-sobi-roche\/#FDA_Grants_Orphan_Drug_Designation_to_PBI-200_for_NTRK_Fusion%E2%80%93Positive_Solid_Tumors\" >FDA Grants Orphan Drug Designation to PBI-200 for NTRK Fusion\u2013Positive Solid Tumors<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-abbvie-sobi-roche\/#Merck_to_Acquire_Seagen_for_Nearly_USD_40_Billion\" >Merck to Acquire Seagen for Nearly USD 40 Billion<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-abbvie-sobi-roche\/#FDA_Grants_Priority_Review_to_Roches_T-cell_Engager_Lunsumio_For_Follicular_Lymphoma_Treatment\" >FDA Grants Priority Review to Roche\u2019s T-cell Engager Lunsumio For Follicular Lymphoma Treatment<\/a><\/li><\/ul><\/nav><\/div>\n\n<h2 class=\"wp-block-heading\" id=\"h-novo-nordisk-reports-phase-iii-results-of-concizumab-drug-for-hemophilia-a-or-b\"><span class=\"ez-toc-section\" id=\"Novo_Nordisk_Reports_Phase_III_Results_of_Concizumab_Drug_for_Hemophilia_A_or_B\"><\/span><strong>Novo Nordisk Reports Phase III Results of Concizumab Drug for Hemophilia A or B<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Novo Nordisk<\/strong> has announced Phase III results for their <strong>concizumab <\/strong>drug for hemophilia A or B, demonstrating efficacy in preventing bleeding events and paving the way for regulatory filings later this year. Concizumab, an anti-tissue factor pathway inhibitor (TFPI) antibody, reduced the number of treated bleeds in patients by <strong>86%<\/strong> when given as a once-daily subcutaneous injection in the <strong>Explorer7 trial<\/strong>. The findings were presented at the <strong>International Society on Thrombosis and Haemostasis (ISTH)<\/strong> annual meeting.<\/p>\n\n\n\n<p>It also achieved a median annualized bleed rate (ABR) of <strong>0.0<\/strong>, compared to <strong>9.8<\/strong> with no prophylaxis, which was comparable to the outcomes obtained in other trials presented at ISTH for two Sanofi drugs- <strong>fitusiran<\/strong> in hemophilia A and B and <strong>efanesoctocog alfa <\/strong>in <a href=\"https:\/\/www.delveinsight.com\/report-store\/hemophilia-a2030-market\">hemophilia A<\/a>. The study included patients with hemophilia A and B who had inhibitors &#8211; antibodies that can impair the activity of clotting factor replacement therapy.<\/p>\n\n\n\n<p><strong>Novo Nordisk<\/strong> discontinued two Phase III studies and one Phase II trial in March 2020 after three patients developed non-fatal blood clots. The FDA also put the initiative on hold for clinical trials. However, Novo restarted development in August 2020 after discovering a &#8220;new way forward.&#8221;<\/p>\n\n\n\n<p>The company plans to file for approval of concizumab in the United States and Japan before the end of this year and in Europe in 2023. Concizumab, according to the company, has the potential to be a <strong>USD 1 billion-plus<\/strong> drug.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"AbbVie_Pulls_its_Alliance_with_Alector_For_Alzheimers_Disease_Candidate_AL003\"><\/span><strong>AbbVie Pulls its Alliance with Alector For Alzheimer\u2019s Disease Candidate AL003<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>AbbVie <\/strong>has ended its collaboration with <strong>Alector <\/strong>on the development of Alzheimer&#8217;s disease candidate <strong>AL003<\/strong>, which attempts to treat the neurodegenerative disease by restoring decreased immune system activation in the brain.<\/p>\n\n\n\n<p>In 2017, <strong>AbbVie <\/strong>began a partnership with <strong>Alector<\/strong>, paying <strong>USD 205 million<\/strong> upfront for exclusive rights to two therapeutic concepts. The agreement represents a departure from the prevalent amyloid hypothesis, which has been the target of numerous <a href=\"https:\/\/www.delveinsight.com\/report-store\/alzheimers-disease-ad-market\">Alzheimer&#8217;s drug candidates<\/a> who have attempted and failed to combat the disease over the previous 25 years but remains the primary focus of drug development for the condition.<\/p>\n\n\n\n<p>Late last year, <strong>Alector <\/strong>presented Phase I data on one of the candidates, <strong>AL003<\/strong>, in healthy volunteers, demonstrating that the candidate is well tolerated up to once-monthly intravenous doses of <strong>15 mg\/kg<\/strong> and engages the transmembrane receptor CD33 in both blood and central nervous system compartments. <strong>SIGLEC 3<\/strong> is an inhibitory receptor found largely on myeloid lineage cells such as microglia, which are part of the brain&#8217;s immune system. Based on the data, Alector, which is in charge of developing and carrying out Phase I and II studies, has planned to advance to the next stage of development in the second half of 2022.<\/p>\n\n\n\n<p>Now that the study is complete, <strong>AL003 <\/strong>has been discarded, dealing a blow to one of the few alternative avenues for <a href=\"https:\/\/www.delveinsight.com\/report-store\/alzheimers-disease-ad-pipeline-insight\">Alzheimer&#8217;s therapy<\/a> that drug developers are pursuing. It will also sever Alector&#8217;s possible future revenue stream from the alliance, which includes up to <strong>USD 986 million<\/strong> in option and milestone payments.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"ADC_Therapeutics_and_Sobi_Enters_in_Exclusive_Licensing_Deal_to_Develop_and_Commercialize_Zynlonta\"><\/span><strong>ADC Therapeutics and Sobi Enters in Exclusive Licensing Deal to Develop and Commercialize Zynlonta<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>ADC Therapeutics<\/strong> announced that it took up an exclusive license agreement with <strong>Swedish Orphan Biovitrum AB<\/strong> for the development and commercialization of <strong>Zynlonta <\/strong>for all hematologic and solid tumor indications outside of the United States, greater China, Singapore and Japan. The Marketing Authorization Application for Zynlonta was validated by the European Medicines Agency at the end of <strong>October 2021<\/strong>, and orphan drug designation was granted for Zynlonta for the <a href=\"https:\/\/www.delveinsight.com\/report-store\/diffuse-large-b-cell-lymphoma-pipeline-insight\"><strong>diffuse large B-cell lymphoma treatment<\/strong><\/a> in Europe. ADC Therapeutics and Sobi intend to make Zynlonta available following a regulatory decision that is expected by the first quarter of 2023. In the agreement clause, ADC Therapeutics is liable to receive an upfront payment of <strong>USD 55 million,<\/strong> and is also eligible to receive USD 50 million upon regulatory approval of <a href=\"https:\/\/www.delveinsight.com\/report-store\/diffuse-large-b-cell-lymphoma-market\"><strong>Zynlonta in third-line DLBCL<\/strong><\/a> by the European Commission and up to approximately<strong> USD 330 million<\/strong> in additional regulatory and sales milestones.&nbsp;<\/p>\n\n\n\n<p>On<strong> April 2021,<\/strong> an accelerated approval was granted to Zynlonta by the US FDA as the first and only CD19-targeted ADC as a single-agent treatment for <a href=\"https:\/\/www.delveinsight.com\/report-store\/diffuse-large-b-cell-lymphoma-epidemiology-forecast\"><strong>adult patients with relapsed or refractory DLBCL<\/strong><\/a> after two or more lines of systemic therapy. ADC Therapeutics also dealt with <strong>Mitsubishi Tanabe Pharma <\/strong>Corporation and signed an exclusive license agreement for the development and commercialization of Zynlonta for all <strong>hematologic<\/strong> and solid tumor indications in Japan.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"BMS_Opdivo_Gets_NHS_Use_as_Adjuvant_Bladder_Cancer_Treatment\"><\/span><strong>BMS\u2019 Opdivo Gets NHS Use as Adjuvant Bladder Cancer Treatment<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>NICE<\/strong> recommended routine use of <strong>Bristol-Myers Squibb\u2019s Opdivo<\/strong> for the adjuvant <a href=\"https:\/\/www.delveinsight.com\/report-store\/urothelial-carcinoma-market\"><strong>treatment of patients with urothelial carcinoma<\/strong><\/a> considered to be the most common form of bladder cancer. The guidance allows Opdivo (nivolumab) to be used after surgery in patients with muscle-invasive UC who are at high risk of the cancer coming back, and whose tumours express <strong>PD-L1<\/strong> at a level of 1% or more. It is only recommended for patients who cannot be treated with adjuvant platinum-based chemotherapy. Currently, more than 50% of patients with bladder cancer will experience recurrence after surgery, and the disease kills nearly <strong>200,000 patients<\/strong> worldwide every year.<\/p>\n\n\n\n<p>The green flag makes Opdivo a second immunotherapy option for <strong>NHS patients<\/strong> with this form of cancer after <strong>Roche\u2019s Tecentriq (atezolizumab)<\/strong>, which can currently be used as an alternative to chemo in untreated locally advanced or metastatic UC expressing PD-L1 at a level of 5% or more. NICE based its decision on the results of the <strong>Phase 3 CheckMate-274 study<\/strong>, which showed that almost 68% of patients treated with Opdivo after surgical resection of their tumour were still alive and disease-free <strong>12 months<\/strong> later, compared to <strong>46%<\/strong> of those receiving placebo.<\/p>\n\n\n\n<p>Opdivo was approved in <strong>Europe <\/strong>for use as an <a href=\"https:\/\/www.delveinsight.com\/report-store\/urothelial-carcinoma-pipeline-insight\"><strong>adjuvant therapy for&nbsp; urothelial carcinoma<\/strong><\/a> earlier this year, its third post-surgery indication after melanoma and oesophageal\/gastroesophageal junction cancer. Securing approvals in the adjuvant or neoadjuvant setting is a key strategy for BMS and other checkpoint inhibitor developers, as it allows them to position their immunotherapies as early as possible in the treatment pathway.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"AstraZeneca_Signs_USD_13_Billion_Deal_to_Acquire_TeneoTwo\"><\/span><strong>AstraZeneca Signs USD 1.3 Billion Deal to Acquire TeneoTwo<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>AstraZeneca<\/strong> declared that the company had acquired <strong>TeneoTwo<\/strong>, including the<strong> phase I clinical-stage CD19\/CD3 T-cell engager<\/strong>, <strong>TNB-486<\/strong>, which is presently under evaluation in <strong>relapsed\/refractory <\/strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/b-cell-non-hodgkin-lymphoma-market\"><strong>B-cell non-Hodgkin lymphoma<\/strong><\/a>.<\/p>\n\n\n\n<p>The acquisition of <strong>TNB-486<\/strong> aims to advance the development of the potential new medicine for <strong>B-cell hematologic malignancies<\/strong>, which includes <a href=\"https:\/\/www.delveinsight.com\/report-store\/diffuse-large-b-cell-lymphoma-market\"><strong>diffuse large B-cell lymphoma (DLBCL)<\/strong><\/a> and <a href=\"https:\/\/www.delveinsight.com\/report-store\/follicular-lymphoma-market-insights\"><strong>follicular lymphoma<\/strong><\/a>. Building on the success of <strong>Calquence<\/strong>, TNB-486 additionally expands into AstraZeneca\u2019s hematology pipeline that spans various therapeutic modalities and mechanisms to address a broad category of blood cancers.<\/p>\n\n\n\n<p>T-cell engagers are molecules designed to drive the <strong>T-cells<\/strong> of the immune system to identify and eradicate cancer cells. TNB-486 activates and recruits T-cells to<strong> CD19-expressing tumors<\/strong>, where they can elicit an immune response by binding to both <strong>CD19<\/strong> and to the <strong>CD3 receptor<\/strong> on T-cells.<\/p>\n\n\n\n<p>AstraZeneca will acquire all the outstanding shares of TeneoTwo in exchange for an upfront payment of <strong>$100m<\/strong>.<\/p>\n\n\n\n<p>Under the agreement terms, AstraZeneca will make additional contingent R&amp;D-related milestone payments of up to <strong>$805m<\/strong> and other contingent commercial-related milestone payments of up to <strong>$360m<\/strong> to TeneoTwo\u2019s equity holders.<\/p>\n\n\n\n<p>The transaction will close in the 3rd quarter of 2022, subject to customary closing conditions and regulatory clearances. The transaction does not impact AstraZeneca\u2019s financial guidance for 2022.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"FDA_Grants_Orphan_Drug_Designation_to_PBI-200_for_NTRK_Fusion%E2%80%93Positive_Solid_Tumors\"><\/span><strong>FDA Grants Orphan Drug Designation to PBI-200 for NTRK Fusion\u2013Positive Solid Tumors<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The <strong>FDA <\/strong>granted an orphan drug designation to <strong>PBI-200<\/strong> for the treatment of patients suffering with <a href=\"https:\/\/www.delveinsight.com\/report-store\/trk-fusion-cancer-market\"><strong>NTRK fusion-positive solid tumors<\/strong><\/a>, comrising <a href=\"https:\/\/www.delveinsight.com\/report-store\/pediatric-brain-tumors-market\"><strong>primary<\/strong> and <strong>metastatic brain tumors<\/strong><\/a>.<\/p>\n\n\n\n<p>Preclinical studies in <strong>intracranial xenograft models <\/strong>demonstrated that PBI-200 offered high efficiency and a manageable safety profile in comparison to other TRK inhibitors.&nbsp;<\/p>\n\n\n\n<p>PBI-200 will undergo evaluation in the <strong>phase I\/II PBI-200-101 trial<\/strong> in patients suffering with <strong>NTRK fusion-positive advanced\/metastatic tumors<\/strong>, comprising <strong>primary <\/strong>and <strong>metastatic central nervous system (CNS) tumors<\/strong>. The trial is comprised of a <strong>dose-escalation phase<\/strong> and <strong>multicohort expansion<\/strong> at the recommended <strong>phase II dose<\/strong>.<\/p>\n\n\n\n<p>In phase I, patients will be required to have <strong>EWSR1 WT1\u2013positive desmoplastic small round cell tumors<\/strong>. Those with NTRK fusion-positive solid tumors other than primary brain tumors are required to have received prior treatment with a TRK inhibitor unless the patient did not have access to treatment with a TRK inhibitor. Patients with <strong>NTRK-amplified solid tumors, primary brain tumors<\/strong>, or <strong>EWSR1 WT1\u2013positive DSRCTs<\/strong> may have received prior treatment with a TRK inhibitor, although it is not required.<\/p>\n\n\n\n<p>Key exclusion criteria include having received treatment with <strong>cytotoxic chemotherapy<\/strong>, a biologic agent, an investigational agent, or radiation therapy within three weeks of the first dose of PBI-200; or having received treatment with <strong>small molecule kinase inhibitors<\/strong> or <strong>hormonal agents<\/strong> within 14 days and five half-lives prior to the first dose of PBI-200.<\/p>\n\n\n\n<p>Notably, patients with either primary brain tumors or brain metastasis must have completed brain radiation <strong>12 weeks<\/strong> prior to the trial\u2019s baseline brain MRI, which will be performed four weeks before the first dose of PBI-200.<\/p>\n\n\n\n<p>The primary endpoints of the phase I portion of the trial include examining adverse effects and establishing the <strong>RP2D<\/strong> of the investigative agent. Secondary endpoints include the area under the plasma drug concentration-time curve after one dose and 28 doses, overall response rate (ORR), duration of response, and progression-free survival.<\/p>\n\n\n\n<p>In phase 2 of the trial, ORR will serve as the primary endpoint in each cohort examined.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Merck_to_Acquire_Seagen_for_Nearly_USD_40_Billion\"><\/span><strong>Merck to Acquire Seagen for Nearly USD 40 Billion<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>In one of the latest commercial updates in the healthcare industry, Merck is set to acquire Seagen for nearly USD 40 Billion. Merck will present the second-quarter earnings report on July 28, 2022, and both companies are hoping to finalize the deal before that. Merck is expected to pay above $200 per share. The acquisition talk started in late June and is expected to be completed within the next few weeks.&nbsp;<\/p>\n\n\n\n<p>Both the parties are in the advanced stages of completing the deal, which could be the world\u2019s largest biopharma acquisition since 2020. Earlier in June 2019, AbbVie announced the purchase of Allergan for $63 billion. AstraZeneca bought the rare disease specialist Alexion for a $39 billion deal in 2021.<\/p>\n\n\n\n<p>Seagen, previously known as Seattle Genetics, is one of the largest biotechnology companies in the USA, focussing on developing and commercializing innovative, empowered monoclonal antibody-based therapies for cancer treatment. The company has delivered several transformative cancer therapies.&nbsp;<\/p>\n\n\n\n<p>Merck has several world\u2019s <a href=\"https:\/\/www.delveinsight.com\/blog\/oncological-drugs-to-be-launch-in-2022\"><strong>best-selling cancer drugs<\/strong><\/a>, including its&nbsp; PD-1 inhibitor Keytrudal. Seagen\u2019s acquisition is expected to further bolster Merck\u2019s presence in the oncology segment. Merck will tap Seagen\u2019s industry-leading ADC technology.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"FDA_Grants_Priority_Review_to_Roches_T-cell_Engager_Lunsumio_For_Follicular_Lymphoma_Treatment\"><\/span><strong>FDA Grants Priority Review to Roche\u2019s T-cell Engager Lunsumio For Follicular Lymphoma Treatment<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The FDA has granted a priority review to Roche\u2019s T-cell engager Lunsumio as a<strong> <\/strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/follicular-lymphoma-market-insights\"><strong>treatment for follicular lymphoma (FL)<\/strong><\/a>. Lunsumio\u00ae (mosunetuzumab) could be the first FDA-approved CD20xCD3 T-cell engaging bispecific antibody for the treatment of any type of non-Hodgkin lymphoma. Lunsumio is being studied for other indications, including follicular lymphoma, diffuse large B-cell lymphoma, and other blood cancers.&nbsp;<\/p>\n\n\n\n<p>The phase I\/II study result has induced high and durable complete response rates, which has played a pivotal role in granting the Priority Review designation. A robust clinical development program for Lunsumio is ongoing, investigating the molecule as a monotherapy and in combination with other medicines.&nbsp;<\/p>\n\n\n\n<p>Lunsumio (mosunetuzumab) has already been approved in the EU for that indication based on the results of a phase 1\/2 study. The Lunsumio has shown an overall response rate of 80% and a median progression-free survival of around 18 months when used as a third-line or later therapy. If approved by the FDA, Lunsumio is expected to offer an off-the-shelf alternative to CAR-T therapies like Gilead Sciences\u2019 Yescarta (axicabtagene ciloleucel) and Novartis\u2019 Kymriah (tisagenlecleucel).&nbsp;<\/p>\n\n\n\n<p>In the United States, nearly 13,000 new cases of FL will be diagnosed in 2022. The launch of the therapy, Lunsumio, is expected to improve the <a href=\"https:\/\/www.delveinsight.com\/report-store\/follicular-lymphoma-pipeline-insight\"><strong>Follicular Lymphoma treatment<\/strong><\/a> scenario in the coming years.&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Novo Nordisk Reports Phase III Results of Concizumab Drug for Hemophilia A or B Novo Nordisk has announced Phase III results for their concizumab drug for hemophilia A or B, demonstrating efficacy in preventing bleeding events and paving the way for regulatory filings later this year. Concizumab, an anti-tissue factor pathway inhibitor (TFPI) antibody, reduced [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":17954,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_editorskit_title_hidden":false,"_editorskit_reading_time":0,"_editorskit_is_block_options_detached":false,"_editorskit_block_options_position":"{}","advgb_blocks_editor_width":"","advgb_blocks_columns_visual_guide":"","footnotes":""},"categories":[32],"tags":[72,2063,18834,283,284,285,349,12287,420,2831,639,2450],"industry":[17225],"therapeutic_areas":[17245,17228],"class_list":["post-17952","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-alzheimers-disease","tag-bladder-cancer","tag-follicular-lymphoma","tag-hemophilia","tag-hemophilia-a","tag-hemophilia-b","tag-latest-pharma-news","tag-lymphomas","tag-news","tag-non-hodgkin-lymphoma","tag-pharma-news","tag-solid-tumors","industry-pharmaceutical","therapeutic_areas-neurology","therapeutic_areas-oncology"],"acf":[],"yoast_head":"<!-- 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