{"id":21413,"date":"2023-02-24T16:40:25","date_gmt":"2023-02-24T11:10:25","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=21413"},"modified":"2023-05-22T12:19:13","modified_gmt":"2023-05-22T06:49:13","slug":"top-10-oncology-drugs-launches-2023","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/top-10-oncology-drugs-launches-2023","title":{"rendered":"Top 10 Expected Oncology Drug Launches in 2023"},"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-69dcfd8c57c2b\" 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-69dcfd8c57c2b\"  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\/top-10-oncology-drugs-launches-2023\/#Promising_Oncology_Drugs_in_the_Pipeline\" >Promising Oncology Drugs in the Pipeline<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.delveinsight.com\/blog\/top-10-oncology-drugs-launches-2023\/#Polivy_R-CHP\" >Polivy + R-CHP<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.delveinsight.com\/blog\/top-10-oncology-drugs-launches-2023\/#Epcoritamab\" >Epcoritamab<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.delveinsight.com\/blog\/top-10-oncology-drugs-launches-2023\/#Glofitamab\" >Glofitamab<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.delveinsight.com\/blog\/top-10-oncology-drugs-launches-2023\/#SYD985\" >SYD985<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.delveinsight.com\/blog\/top-10-oncology-drugs-launches-2023\/#Trodelvy\" >Trodelvy<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.delveinsight.com\/blog\/top-10-oncology-drugs-launches-2023\/#ORSERDU\" >ORSERDU&nbsp;<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/www.delveinsight.com\/blog\/top-10-oncology-drugs-launches-2023\/#Lynparza\" >Lynparza&nbsp;<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/www.delveinsight.com\/blog\/top-10-oncology-drugs-launches-2023\/#Padcev\" >Padcev<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/www.delveinsight.com\/blog\/top-10-oncology-drugs-launches-2023\/#Brukinsa\" >Brukinsa<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/www.delveinsight.com\/blog\/top-10-oncology-drugs-launches-2023\/#Krazati\" >Krazati<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-12\" href=\"https:\/\/www.delveinsight.com\/blog\/top-10-oncology-drugs-launches-2023\/#Whats_Ahead_in_the_Oncology_Market\" >What\u2019s Ahead in the Oncology Market?<\/a><\/li><\/ul><\/nav><\/div>\n\n<p>Cancer is the world\u2019s second leading cause of death. Every year, <strong>10 million<\/strong> people die from cancer. Cancer kills <strong>70%<\/strong> of people in low-to-middle-income countries. Cancer is estimated to cost the global economy <strong>USD 1.16 trillion<\/strong> per year. Millions of lives could be saved annually by implementing resource-appropriate prevention, early detection, and treatment strategies.&nbsp;&nbsp;<\/p>\n\n\n\n<p>Every year leading goliaths operating in the <a href=\"https:\/\/www.delveinsight.com\/report-store\/oncology-drugs-market\">oncology market<\/a>, including <strong>Roche, AbbVie, Gilead Sciences, AstraZeneca, Merck, Astellas Pharma<\/strong>, and others, works hard to develop novel oncology drugs that would lower the burden on the patients. This year, the oncology drugs pipeline is also looking robust, with promising candidates such as <strong>Lynparza, Trodelvy, Glofitamab, Epcoritamab<\/strong>, and others. The launch of these oncology drugs will give a sign of relief to all the patients suffering from different types of cancer.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-promising-oncology-drugs-in-the-pipeline\"><span class=\"ez-toc-section\" id=\"Promising_Oncology_Drugs_in_the_Pipeline\"><\/span><strong>Promising Oncology Drugs in the Pipeline<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The oncology drug pipeline comprises some highly anticipated therapies representing new drug classes and distinct MoAs. These oncology drugs will create significant market opportunities across a wide range of indications. Let\u2019s dive deep into the upcoming oncology drugs and learn more about them.&nbsp;<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Polivy_R-CHP\"><\/span><strong>Polivy + R-CHP<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p><strong>Drug:&nbsp;<\/strong>Polivy + R-CHP (Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone)<\/p>\n\n\n\n<p><strong>Mechanism of Action: <\/strong>CD79b targeted ADC<\/p>\n\n\n\n<p><strong>Company:&nbsp;<\/strong>Roche-Genentech\/Chugai Pharmaceuticals<\/p>\n\n\n\n<p><strong>Indication:&nbsp;<\/strong>Diffuse Large B-cell Lymphoma (DLBCL) (1L)&nbsp;<\/p>\n\n\n\n<p><strong>Estimated 2030 sales in the US:&nbsp;<\/strong>~USD 850 million [1L+, 2L+ (Non transplant eligible {NTE}), and 3L+]<\/p>\n\n\n\n<p>Eyes on <strong>Roche\u2019s Polivy + R-CHP<\/strong>, expected to launch in 2023 in the United States for patients with untreated DLBCL. The company has high hopes for Polivy + R-CHP as the FDA has set a PDUFA goal date of <strong>April 2, 2023<\/strong>. Polivy + R-CHP showed a <strong>27%<\/strong> PFS benefit over R-CHOP, although the overall survival (OS) at 2 years was <strong>88.7%<\/strong> in the Polivy + R-CHP group and <strong>88.6%<\/strong> in the R-CHOP group with no significant difference in both regimes. Polivy, in this combination, is expected to be the first ADC that could revolutionize the field of untreated <a href=\"https:\/\/www.delveinsight.com\/report-store\/diffuse-large-b-cell-lymphoma-market\">DLBCL treatment<\/a>.<\/p>\n\n\n\n<p>R-CHOP continues to be challenged to better patient outcomes through novel drug combinations and therapeutic approaches. Polivy demonstrated a considerable uptake due to its efficiency in improving patient outcomes with DLBCL. Despite previous failures in 1L DLBCL, <strong>POLIVY<\/strong>, combined with R-CHP in 1L DLBCL, has now received approval in more than 50 countries. It was approved in Europe in May 2022, followed by Japan in August 2022.<\/p>\n\n\n\n<p>As per Delveinsight\u2019s estimates, Polivy made <strong>\u02dcUSD 450 million<\/strong> in the seven major markets (US, EU4 and the UK, and Japan) in 2022 from its usage in 3L (US) and 2L NTE (Europe and Japan), and a significant uptake is anticipated from Polivy in the upcoming year owing to first-mover advantage in the first-line setting. However, this oncology drug might face competition with other emerging bi-specific antibodies and CAR-Ts entering later in this line. In the future, the willingness of physicians to prescribe Polivy with R-CHP as first-line therapy will also be a key factor in winning over patients. However, Polivy + R-CHP\u2019s acceptance may be affected in 1L treatment due to the lack of an OS benefit.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Epcoritamab\"><\/span><strong>Epcoritamab<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p><strong>Drug:&nbsp;<\/strong>Epcoritamab<\/p>\n\n\n\n<p><strong>Mechanism of Action: <\/strong>CD20 and CD3 directed bispecific antibody<\/p>\n\n\n\n<p><strong>Company:&nbsp;<\/strong>AbbVie and Genmab<\/p>\n\n\n\n<p><strong>Indication:&nbsp;<\/strong>Diffuse Large B-cell Lymphoma (3L+)&nbsp;<\/p>\n\n\n\n<p><strong>Estimated 2030 sales in the US:&nbsp;<\/strong>~USD 900 million [1L+, 2L+ (NTE and Transplant eligible {TE}), and 3L+]&nbsp;<\/p>\n\n\n\n<p><strong>Epcoritamab <\/strong>is all set to become the first-ever bispecific antibody ever approved for DLBCL treatment, with a PDUFA action date set for <strong>May 21, 2023<\/strong>. This oncology drug wowed the crowd in terms of efficacy in R\/R DLBCL by achieving an overall response rate (ORR) of <strong>63%<\/strong>, with a complete response rate (CRR) of <strong>39%<\/strong> from the <strong>EPCORE NHL-1 trial<\/strong>. European Medicines Agency (EMA) also validated Marketing Authorization Application (MAA) for R\/R DLBCL last year. Although the occurrence of Grade 3 Cytokine Release Syndrome (CRS) with monotherapy tones down epcoritamab\u2019s potentially best-in-class safety profile yet the effectiveness surpasses its tolerable safety concerns.<\/p>\n\n\n\n<p>Bispecific antibodies will gain a sizable market share in 3L+ DLBCL as CAR-T and ADCs advance in earlier lines. Apart from<a href=\"https:\/\/www.delveinsight.com\/report-store\/diffuse-large-b-cell-lymphoma-market\"> 3L R\/R DLBCL treatment<\/a>, the drug is also being evaluated in combinations with other agents in an earlier lines of therapies, including first-line, first-R\/R transplant-eligible, and first-R\/R transplant-ineligible. While epcoritamab\u2019s first-mover advantage would give it an edge in the bispecific antibodies space, glofitamab\u2019s fixed-duration treatment could be a major selling point.&nbsp;<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Glofitamab\"><\/span><strong>Glofitamab<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p><strong>Drug:&nbsp;<\/strong>Glofitamab<\/p>\n\n\n\n<p><strong>Mechanism of Action: <\/strong>CD20 and CD3 directed bispecific antibody<\/p>\n\n\n\n<p><strong>Company:&nbsp;<\/strong>Roche<\/p>\n\n\n\n<p><strong>Indication:&nbsp;<\/strong>Diffuse Large B-cell Lymphoma (3L+)&nbsp;<\/p>\n\n\n\n<p><strong>Estimated 2030 sales in the US:<\/strong>&nbsp;~USD 650 million (1L+, 2L+ (NTE), and 3L+)<\/p>\n\n\n\n<p><strong>Roche\u2019s glofitamab <\/strong>is not too far behind in the race from epcoritimab. As <strong>AbbVie\u2019s <\/strong>possible competitor, Roche gets closer to entering the <a href=\"https:\/\/www.delveinsight.com\/report-store\/diffuse-large-b-cell-lymphoma-market\">DLBCL market<\/a> and is excavating its roadway with newer modifications for the drug glofitamab.<\/p>\n\n\n\n<p>Roche filed for approval of glofitamab in April 2022 in Europe for 3L R\/R DLBCL, and the FDA is expected to decide on approval by July 1, 2023, based on results from the <strong>Phase I\/II NP30179 study<\/strong>, where<strong> 51.6%<\/strong> of patients achieved an ORR, with <strong>40%<\/strong> achieving a CRR.&nbsp;<\/p>\n\n\n\n<p>If approved, glofitamab would be the first fixed-duration, off-the-shelf CD20xCD3 T-cell engaging bispecific antibody available to treat people with aggressive lymphoma who have previously received multiple courses of treatment. Fixed-duration treatment is a key selling point that Roche thinks could differentiate its bispecific from the others and give head-to-head competition to epcoritamab.&nbsp;<\/p>\n\n\n\n<p>The company anticipates submission to health authorities for glofitamab + chemotherapy in 2L DLBCL by 2024 and glofitamab + chemotherapy in 1L circulating tumor (ct) DNA + high-risk DLBCL by 2025 and beyond.<\/p>\n\n\n\n<p>Roche has another CD20xCD3 bispecific antibody, <strong>LUNSUMIO (mosunetuzumab)<\/strong>, being developed along with <strong>Biogen <\/strong>is also a fixed-duration treatment that can be administered in the outpatient setting, which could allow people the possibility of experiencing a lasting remission with a treatment-free period. It\u2019s recent approval for <a href=\"https:\/\/www.delveinsight.com\/report-store\/follicular-lymphoma-market-insights\">follicular lymphoma treatment<\/a> has made its portfolio strong and given more hope for approval in DLBCL treatment.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"SYD985\"><\/span><strong>SYD985<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p><strong>Drug:&nbsp;<\/strong>SYD985 (Trastuzumab Duocarmazine)<\/p>\n\n\n\n<p><strong>Mechanism of Action: <\/strong>HER2 binding ADC, which interrupts DNA replication and results in tumor cell death<\/p>\n\n\n\n<p><strong>Company:&nbsp;<\/strong>Byondis<\/p>\n\n\n\n<p><strong>Indication:&nbsp;<\/strong>HER2+ metastatic breast cancer (3L+)<\/p>\n\n\n\n<p><strong>Estimated 2030 sales in the US:&nbsp;<\/strong>Not estimated<\/p>\n\n\n\n<p><strong>SYD985 <\/strong>is <strong>Byondis\u2019 <\/strong>first product ever expected to hit the market. There are several HER2-targeting ADCs in development, but <strong>Byondis\u2019 SYD985<\/strong> is currently gaining steam and is anticipated to launch in 2023. According to Phase III results from the <strong>TULIP study<\/strong> in <a href=\"https:\/\/www.delveinsight.com\/report-store\/metastatic-her2-positive-breast-cancer-market\">3L+ HER2+ metastatic breast cancer<\/a>, hitting its primary endpoint with an mPFS of 7.0 months vs. 4.9 months for physician\u2019s choice chemotherapy and also demonstrated supportive overall survival (OS) results. Data support the potential of SYD985 to address the high unmet need of patients with HER2+ breast cancer. Adverse events for SYD985 include conjunctivitis (<strong>38.2%<\/strong>), keratitis (<strong>38.2%<\/strong>), and fatigue (<strong>33.3%<\/strong>) which may permanently occur if not properly treated, which could jeopardize the drug\u2019s approval.<\/p>\n\n\n\n<p>The FDA granted <strong>fast-track designation<\/strong> based on Phase I results, whereas last year, based on Phase III results, FDA gave a PDUFA action date of <strong>May 12, 2023<\/strong>. Byondis is exploring partnerships with big pharm to enable commercialization.<\/p>\n\n\n\n<p><strong>Byondis TULIP\u2019s<\/strong> 7 months mPFS appears moderate compared to <strong>ENHERTU\u2019S<\/strong> 18 months mPFS in the <a href=\"https:\/\/www.delveinsight.com\/esmo-conference-2021\/article\/esmo-2021-abstract-lba1\"><strong>DESTINY-Breast01 trial<\/strong><\/a>; hence it is not expected to be a growing threat to <a href=\"https:\/\/www.delveinsight.com\/blog\/enhertu-for-cancer-treatment-and-management\"><strong>ENHERTU<\/strong><\/a>.<\/p>\n\n\n\n<figure class=\"wp-block-image size-large is-resized\"><img decoding=\"async\" src=\"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2023\/02\/23162259\/Promising-Oncology-Drugs-1024x543.png\" alt=\"Promising Oncology Drugs\" class=\"wp-image-21427\" width=\"1024\" height=\"543\" srcset=\"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2023\/02\/23162259\/Promising-Oncology-Drugs-1024x543.png 1024w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2023\/02\/23162259\/Promising-Oncology-Drugs-300x159.png 300w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2023\/02\/23162259\/Promising-Oncology-Drugs-150x80.png 150w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2023\/02\/23162259\/Promising-Oncology-Drugs-768x407.png 768w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2023\/02\/23162259\/Promising-Oncology-Drugs.png 1210w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><figcaption class=\"wp-element-caption\"><strong>Top Oncological Drugs to be Launched in 2023<\/strong><\/figcaption><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Trodelvy\"><\/span><strong>Trodelvy<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p><strong>Drug:&nbsp;<\/strong>Trodelvy<\/p>\n\n\n\n<p><strong>Mechanism of Action: <\/strong>Trop-2-directed antibody-drug conjugate<\/p>\n\n\n\n<p><strong>Company:&nbsp;<\/strong>Gilead Sciences<\/p>\n\n\n\n<p><strong>Indication:&nbsp;<\/strong>HR+\/HER2- breast cancer (3L+)<\/p>\n\n\n\n<p><strong>Estimated 2030 sales in the US:<\/strong> ~USD 350 million (3L+)<\/p>\n\n\n\n<p><strong>Trodelvy <\/strong>is approved in more than 40 countries. Trodelvy has already changed the treatment landscape in second-line metastatic triple-negative breast cancer and pre-treated metastatic urothelial cancer and has previously grabbed a significant market share. On <strong>February 3, 2023<\/strong>, the FDA approved Trodelvy for <a href=\"https:\/\/www.delveinsight.com\/report-store\/metastatic-her2-positive-breast-cancer-market\">HR+\/HER2- breast cancer patients<\/a> based on the <a href=\"https:\/\/www.delveinsight.com\/esmo-conference-2022\/article\/trodelvy-tropics-02-result\"><strong>Phase III TROPiCS-02 trial<\/strong><\/a>. Roche is also exploring <strong>TRODELVY <\/strong>in Europe for HR+\/HER2- breast cancer. We expected it to get a green signal from EMA in 2023 as EMA has already validated the MAA application on <strong>January 5, 2023<\/strong>.<\/p>\n\n\n\n<p>As per data presented in <a href=\"https:\/\/www.delveinsight.com\/asco-conference-2022\"><strong>ASCO 2022<\/strong><\/a><strong> and <\/strong><a href=\"https:\/\/www.delveinsight.com\/esmo-conference-2022\"><strong>ESMO 2022<\/strong><\/a> last year, Trodelvy demonstrated a <strong>34%<\/strong> reduction in risk of disease progression or death (median PFS: 5.5 vs. 4 months) and a <strong>21%<\/strong> decrease in the risk of death compared to treatment of physician\u2019s choice (TPC) (median OS: 14.4 months vs. 11.2 months).<\/p>\n\n\n\n<p>Currently, breast cancer (starting with TNBC)&nbsp;accounts for <strong>90%<\/strong> of Trodelvy\u2019s business. Trodelvy is expected to emerge as a blockbuster candidate however, boxed warning for severe or life-threatening neutropenia and severe diarrhea could impact the uptake of <strong>TRODELVY<\/strong>. However, the possible competition could impact Trodelvy\u2019s growth in the coming years. Trodelvy is anticipated to face competition from <strong>AstraZeneca\/Daiichi Sankyo Dato-DXd, Sermonix Pharma\u2019s Fablyn (Lasofoxifene), and Veru Pharma\u2019s Enobosarm<\/strong> in 3L HR+\/HER2- Breast cancer treatment.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><strong>Want to know which oncology drugs got approved in 2022? Visit, <\/strong><a href=\"https:\/\/www.delveinsight.com\/blog\/oncological-drugs-to-be-launch-in-2022\"><strong>Oncology Drugs Launches 2022<\/strong><\/a><\/p>\n<\/blockquote>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"ORSERDU\"><\/span><strong>ORSERDU&nbsp;<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p><strong>Drug:&nbsp;<\/strong>ORSERDU (elacestrant)<\/p>\n\n\n\n<p><strong>Mechanism of Action: <\/strong>Selective estrogen receptor degrade (SERD)<\/p>\n\n\n\n<p><strong>Company:&nbsp;<\/strong>Radius Health\/Menarini<\/p>\n\n\n\n<p><strong>Indication:&nbsp;<\/strong>ER+\/HER2-, ESR1-mutated advanced or metastatic breast cancer (2L+)<\/p>\n\n\n\n<p><strong>Estimated 2030 sales in the US:<\/strong> ~USD 160 million (2L+)<\/p>\n\n\n\n<p>It has been a great start to the new year with the approval of much awaited <strong>Next Generation SERD, elacestrant<\/strong> in ESR1-mutated HR+\/HER2- breast cancer giving new hope to patients. By bringing the first oral selective estrogen receptor degrader (SERD) to treat breast cancer across the FDA finish line, Menarini wins the race where <strong>Roche and Sanofi<\/strong> have lost sight. ORSERDU is not the first SERD for breast cancer to be approved in the market. In 2002, AstraZeneca received an FDA nod for <strong>Faslodex <\/strong>for HR+ metastatic breast cancer, whose cancer has progressed following prior antiestrogen therapy. Elacestrant is expected to be widely adopted given the oral advantages and the improved efficacy compared to Faslodex.<\/p>\n\n\n\n<p>The regulatory decision was based on data from the <strong>Phase III EMERALD trial<\/strong>, in which elacestrant reduced the risk of disease progression or death by <strong>45%<\/strong> compared with fulvestrant or an aromatase inhibitor. The mPFS with elacestrant was 3.8 months vs. 1.9 months with the control.<\/p>\n\n\n\n<p>Priority review and fast-track designations for elacestrant were previously granted by the FDA, and a PDUFA date of <strong>February 2023<\/strong> was set. Three weeks before the deadline, the agency revealed its final decision. Other next-generation oral SERD candidate <strong>giredestrant and amcenestrant <\/strong>from <strong>Roche <\/strong>and <strong>Sanofi, <\/strong>respectively, flopped <a href=\"https:\/\/www.delveinsight.com\/report-store\/metastatic-breast-cancer-pipeline-insight\">breast cancer trials<\/a> last year, and Sanofi later stopped developing its drug.<\/p>\n\n\n\n<p>Competitors outperform <strong>Menarini\u2019s Elacestrant<\/strong> in 1L and adjuvant settings. In contrast to most of its rivals, Menarini has only recently begun Phase I\/II dose-finding studies of elacestrant with CDK4\/6i. There are no adjuvant studies either. Therefore, Menarini will have the first-mover advantage in key situations.<\/p>\n\n\n\n<p>In the future, Menarini can face competition from <strong>AstraZeneca\u2019s camizestrant<\/strong>, which showed significant results in a Phase II trial last year.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Lynparza\"><\/span><strong>Lynparza&nbsp;<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p><strong>Drug:&nbsp;<\/strong>Lynparza (olaparib)<\/p>\n\n\n\n<p><strong>Mechanism of Action: <\/strong>PARP inhibitor<\/p>\n\n\n\n<p><strong>Company:&nbsp;<\/strong>AstraZeneca\/Merck &amp; Co<\/p>\n\n\n\n<p><strong>Indication:&nbsp;<\/strong>Metastatic Castration-resistant Prostate Cancer (mCRPC) (1L)<\/p>\n\n\n\n<p><strong>Estimated 2030 sales in the US: <\/strong>~USD 550 million (1L)<\/p>\n\n\n\n<p><strong>Lynparza <\/strong>is approved in the US as monotherapy for patients with homologous recombination repair (HRR) gene-mutated mCRPC (BRCA-mutated and other HRR gene mutations) who have progressed following prior treatment with enzalutamide or abiraterone and in the EU, Japan, and China for <a href=\"https:\/\/www.delveinsight.com\/report-store\/metastatic-castration-resistant-prostate-cancer-market\">patients with BRCA-mutated mCRPC<\/a> who have progressed following prior therapy that included a new hormonal agent (NHA). These approvals were based on the data from the <a href=\"https:\/\/www.delveinsight.com\/asco-conference\/article\/astrazeneca-merck-lynparza\"><strong>Phase III PROfound trial<\/strong>.<\/a><\/p>\n\n\n\n<p>FDA granted <strong>Priority Review<\/strong> in August and assigned a PDUFA action date for the fourth quarter of 2022. FDA extends the evaluation period through December 2022 and pushes back the decision deadline by three months. However, at the same time, in December 2022, its label was expanded in Europe, and it was authorized for use in combination with abiraterone, prednisone, or prednisolone for the <a href=\"https:\/\/www.delveinsight.com\/report-store\/metastatic-castration-resistant-prostate-cancer-market\">treatment of adult patients with mCRPC<\/a> in whom chemotherapy is not clinically recommended. In the Phase III PROpel study, the Lynparza + abiraterone arm\u2019s median radiographic progression-free survival (rPFS) was <strong>24.8 months<\/strong> compared to <strong>16.6 months<\/strong> for the placebo + abiraterone arm.<\/p>\n\n\n\n<p>For the title of third PARP inhibitor in the US for mCRPC, <strong>Pfizer\u2019s Talzenna + Xtandi, AstraZeneca\u2019s Lynparza + abiraterone, and Janssen\u2019s Zejula + abiraterone<\/strong> faced off against one another. While Zejula failed in 1L mCRPC patients without HRR, Lynparza, used on top of Zytiga and steroids, cut the risk of disease progression or death in all patients by <strong>34%<\/strong> regardless of HRR status in its <strong>Phase III PROpel trial<\/strong>. With non-HRR-mutated patients, Zejula might not be an option for a broad label, but Talzenna and Lynparza might go up against one another.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Padcev\"><\/span><strong>Padcev<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p><strong>Drug:&nbsp;<\/strong>Padcev (enfortumab vedotin)&nbsp;<\/p>\n\n\n\n<p><strong>Mechanism of Action: <\/strong>Nectin-4-directed antibody-drug conjugate<\/p>\n\n\n\n<p><strong>Company:&nbsp;<\/strong>Seagen\/Astellas Pharma&nbsp;<\/p>\n\n\n\n<p><strong>Indication:&nbsp;<\/strong>Locally advanced or metastatic urothelial cancer (1L)<\/p>\n\n\n\n<p><strong>Estimated 2030 sales in the US: <\/strong>\u02dcUSD 670 million<\/p>\n\n\n\n<p>As a potential treatment option for untreated cisplatin-ineligible patients with locally advanced or metastatic urothelial carcinoma, the combination of <strong>Merck\u2019s Keytruda, Seagen\u2019s, and Astellas\u2019s Padcev<\/strong> have drawn a lot of attention.<\/p>\n\n\n\n<p>Padcev was the first Nectin-4-directed antibody-drug conjugate (ADC) licensed for the treatment of advanced urothelial carcinoma and the 8th ADC approved by the FDA. Padcev\u2019s approval journey began with FDA approval for urothelial cancer treatment in December 2019, continued with Europe approval in March 2021, label expansion in urothelial cancer in the US in July 2021, Japan approval in September 2021, and lasted with Europe approval in April 2022 for adult patients with locally advanced or metastatic urothelial cancer who have previously received treatment with platinum-containing chemotherapy and a <a href=\"https:\/\/www.delveinsight.com\/report-store\/pd-1-and-pd-l1-inhibitors-competitive-landscape\">PD-1\/L1 inhibitor<\/a>. This path will not end anytime soon because the FDA intends to decide whether to approve <strong>Padcev + Keytruda<\/strong> by <strong>April 21, 2023<\/strong>, for the <a href=\"https:\/\/www.delveinsight.com\/report-store\/metastatic-urothelial-carcinoma-market\">treatment of patients with locally advanced or metastatic urothelial carcinoma<\/a> who are ineligible for treatment with cisplatin-based chemotherapy. The sBLA supported by the <strong>Phase I\/II (EV-103\/ KEYNOTE-869) trial<\/strong> results, out of <strong>76 patients<\/strong> who received the combination, <strong>64.5%<\/strong> had tumor shrinkage, with <strong>10.5%<\/strong> showing a complete response. Of the 73 patients on Padcev alone, the rate was <strong>45.2%, with 4.1%<\/strong> responding completely.<\/p>\n\n\n\n<p>A regulator\u2019s approval would not only increase Padcev\u2019s potential sales by billions but would also prolong Keytruda&#8217;s patent protection in the indication through 2027.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Brukinsa\"><\/span><strong>Brukinsa<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p><strong>Drug:&nbsp;<\/strong>Brukinsa (Zanubrutinib)<\/p>\n\n\n\n<p><strong>Mechanism of Action: <\/strong>BTK inhibitor<\/p>\n\n\n\n<p><strong>Company: <\/strong>BeiGene<\/p>\n\n\n\n<p><strong>Indication:&nbsp;<\/strong>Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) (1L and 2L+)<\/p>\n\n\n\n<p><strong>Estimated 2030 sales in the US: <\/strong>Not estimated<\/p>\n\n\n\n<p>There is new hope for <a href=\"https:\/\/www.delveinsight.com\/report-store\/chronic-lymphocytic-leukemia-cll-market\">CLL patients<\/a> after the FDA gave the green light to <strong>Zanubrutinib<\/strong>, a second-generation BTK inhibitor, in <strong>January 2023<\/strong>. Approval is based on two global Phase III clinical trials demonstrating superior efficacy and a favorable safety profile in <strong>ALPINE<\/strong> (R\/R CLL\/SLL) and <strong>SEQUOIA <\/strong>(untreated CLL\/SLL) studies. Given that Brukinsa is a 3rd-in-market BTK inhibitor and entered the market six years after <a href=\"https:\/\/www.delveinsight.com\/report-store\/imbruvica-api-insights\">Imbruvica (ibrutinib)<\/a> suggests that Brukinsa could capture high market share and demonstrate best-in-class potential.<\/p>\n\n\n\n<p>We expect strong uptake of <strong>Brukinsa <\/strong>will continue to ramp up driven by multiple approvals (2L MCL, 2L MZL, and CLL\/SLL in the US) and pivotal data readouts suggesting superior efficacy and safety in ALPINE in CLL over BTK market leader Imbruvica. Covalent first-generation BTK inhibitor intolerance is a major emerging issue with this class of medication due to cardiac issues such as cardiac arrhythmias, atrial fibrillation, or atrial flutter. ALPINE data suggest that atrial fibrillation was better with zanubrutinib vs. ibrutinib. Due to this advantage over ibrutinib in the coming years, we expect Imbruvia to lose its market share to Brukinsa steadily.&nbsp;<\/p>\n\n\n\n<p>With the strong PFS benefit over ibrutinib in ALPINE study, it is well perceived by physicians. Superior relative efficacy vs. Calquence, foreshadowing a strong commercial adoption. As Calquence is currently the market leader in untreated patients of CLL, which starts for the BTK class in untreated patients, and much of the benefit is driven by the more tolerable profile rather than efficacy. Calquence did not demonstrate superiority to Imbruvica in terms of efficacy, but safety is better than Imbruvica.<\/p>\n\n\n\n<p>Moreover, <strong>Lilly\u2019s<\/strong> third-generation noncovalent BTK inhibitor, Pirtobrutinib, is also being evaluated in a <a href=\"https:\/\/www.delveinsight.com\/report-store\/chronic-lymphocytic-leukemia-cll-pipeline-insight\">Phase III trial in CLL treatment<\/a>, which demonstrated good efficacy in the trial. Pirtobrutinib has a theoretical advantage over the currently marketed <strong>BTK inhibitor (Imbruvica, Calquence, Brukinsa) <\/strong>because of its reversible binding that allows for higher BTK inhibition while also reducing off-target toxicity.&nbsp;<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Krazati\"><\/span><strong>Krazati<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p><strong>Drug:&nbsp;<\/strong>Krazati (adagrasib)<\/p>\n\n\n\n<p><strong>Mechanism of Action: <\/strong>Selective covalent inhibitor of KRAS G12C<\/p>\n\n\n\n<p><strong>Company: <\/strong>Mirati Therapeutics<\/p>\n\n\n\n<p><strong>Indication:&nbsp;<\/strong>KRASG12C mutation in Colorectal cancer (CRC) (3L+)<\/p>\n\n\n\n<p><strong>Estimated 2030 sales in the US: <\/strong>\u02dcUSD 180 million (2L and 3L+)<\/p>\n\n\n\n<p>In recent years, KRAS has become one of the most often explored targets in cancer therapies due to its function in the proliferation and expansion of cancer cells. Due to its earlier marketing than <strong>Krazati (adagrasib), Lumakras (sotorasib)<\/strong> has already attained market acceptance.<\/p>\n\n\n\n<p>2023 could be a \u2018massive showcase\u2019 for Krazati as the drug was recently approved in NSCLC in December 2022. We expect this drug to hit the market in KRASG12C&nbsp;CRC this year. The company received the breakthrough designation for KRAS-Mutated CRC based on <a href=\"https:\/\/www.delveinsight.com\/esmo-conference-2022\/article\/krystal-1-study\"><strong>Phase I\/II (KRYSTAL-1) trial<\/strong><\/a><strong>.<\/strong> Now, the company is planning to meet with the FDA to discuss an accelerated approval pathway for 3L+ CRC in the first quarter of 2023. The data from <strong>Phase I\/II KRYSTAL-1 trial<\/strong>, the combination of <strong>adagrasib and cetuximab <\/strong>demonstrated an ORR of <strong>46%<\/strong>, a median duration of response (DOR) of 7.6 months, and a median PFS of 6.9 months.&nbsp;<\/p>\n\n\n\n<p><strong>Amgen and Mirati<\/strong> are in head-to-head competition with each other with their assets <strong>Lumakras and Krazati<\/strong> respectively. Phase II data had hit hard <a href=\"https:\/\/www.delveinsight.com\/esmo-conference-2022\/article\/lumakras-codebreak200\">Lumakras in CRC<\/a> and dashed Amgen\u2019s hopes when ORR was not achieved. However, the company still feels that Lumakras has the potential, i.e., developing Lumakras in combination with other therapeutics to increase potential activity and overcome potential resistance mechanisms. The <strong>sotorasib + panitumumab<\/strong> combination was evaluated in the CodeBreaK 101 study, which had an ORR of <strong>30%<\/strong> and an mPFS of 5.7 months. With combinations in refractory populations, <strong>KRYSTAL-1 and <\/strong><a href=\"https:\/\/www.delveinsight.com\/esmo-conference-2022\/article\/colorectal-cancer-market\"><strong>CodeBreaK 101<\/strong><\/a> demonstrated excellent disease control rates of <strong>100%<\/strong> and <strong>93%<\/strong>, respectively, with median PFS data that outperformed other currently available choices.<\/p>\n\n\n\n<p>Mirati is also conducting a <strong>Phase III KRYSTAL-10 trial <\/strong>evaluating adagrasib in combination with cetuximab in patients with KRASG12C-mutated CRC in the 2L+ compared with standard chemotherapy. However, Amgen is exploring the combination of sotorasib + panitumumab vs. the investigator\u2019s choice of regorafenib or TAS-102 in the <strong>CodeBreaK 300 Phase III trial<\/strong>. Watching whether Amgen or Mirati takes the crown in <a href=\"https:\/\/www.delveinsight.com\/report-store\/colorectal-cancer-crc-market\">CRC treatment<\/a> will be fascinating.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Whats_Ahead_in_the_Oncology_Market\"><\/span><strong>What\u2019s Ahead in the Oncology Market?<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Oncology is a dynamic and fast-evolving therapeutic area, with several key players at the global level engaged in R&amp;D activities to provide an effective therapeutic option for cancer patients. The <a href=\"https:\/\/www.delveinsight.com\/report-store\/oncology-drugs-market\">global oncology drugs market<\/a> has grown significantly in recent years due to various factors such as increased research and development activities, increased awareness, an increase in the geriatric population, an increase in the incidence of various cancer conditions, and growing interest in the domain by key pharmaceutical and biotech companies. Several global pharmaceutical companies are currently active in the oncology therapeutics segment. Moreover, the entry of new players developing <a href=\"https:\/\/www.delveinsight.com\/blog\/digital-health-to-improve-cancer-management\">novel cancer treatments<\/a> is expected to improve the quality of life of affected people and their families in the coming years.<\/p>\n\n\n\n<p>Furthermore, every year regulatory authorities approve many oncological drugs for various indications. The oncological drug pipeline is looking very promising this year too. The anticipated launch of these oncology drugs will give tough competition to already approved drugs in the market. With the robust oncological drug pipeline, we can witness remarkable growth in the oncology market this year.<\/p>\n\n\n\n<figure class=\"wp-block-image size-large is-resized\"><a href=\"https:\/\/www.delveinsight.com\/report-store\/oncology-drugs-market\"><img decoding=\"async\" src=\"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2023\/02\/23122355\/Oncology-Drugs-Market-Outlook-1024x256.png\" alt=\"Oncology Drugs Market Outlook\" class=\"wp-image-21420\" width=\"1024\" height=\"256\" srcset=\"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2023\/02\/23122355\/Oncology-Drugs-Market-Outlook-1024x256.png 1024w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2023\/02\/23122355\/Oncology-Drugs-Market-Outlook-300x75.png 300w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2023\/02\/23122355\/Oncology-Drugs-Market-Outlook-150x38.png 150w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2023\/02\/23122355\/Oncology-Drugs-Market-Outlook-768x192.png 768w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2023\/02\/23122355\/Oncology-Drugs-Market-Outlook-1536x384.png 1536w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2023\/02\/23122355\/Oncology-Drugs-Market-Outlook-1568x392.png 1568w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2023\/02\/23122355\/Oncology-Drugs-Market-Outlook.png 1584w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/a><\/figure>\n","protected":false},"excerpt":{"rendered":"<p>Cancer is the world\u2019s second leading cause of death. Every year, 10 million people die from cancer. Cancer kills 70% of people in low-to-middle-income countries. Cancer is estimated to cost the global economy USD 1.16 trillion per year. Millions of lives could be saved annually by implementing resource-appropriate prevention, early detection, and treatment strategies.&nbsp;&nbsp; Every [&hellip;]<\/p>\n","protected":false},"author":14,"featured_media":21429,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_editorskit_title_hidden":false,"_editorskit_reading_time":12,"_editorskit_is_block_options_detached":false,"_editorskit_block_options_position":"{}","advgb_blocks_editor_width":"","advgb_blocks_columns_visual_guide":"","footnotes":""},"categories":[17],"tags":[20398,127,927,174,18620,16851,20400,19725,18834,19381,17737,17026,19013,1303,19015,427,428,454,578,20399],"industry":[17225],"therapeutic_areas":[17228],"class_list":["post-21413","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-articles","tag-asco-2022","tag-breast-cancer","tag-cancer-treatment","tag-colorectal-cancer","tag-dlbcl","tag-enhertu","tag-epcoritamab","tag-esmo-2022","tag-follicular-lymphoma","tag-glofitamab","tag-imbruvica","tag-kras-inhibitors","tag-lumakras","tag-lynparza","tag-oncological-drugs","tag-oncology","tag-oncology-reports","tag-pd-1-and-pd-l-1-inhibitors","tag-top-10-oncology-drugs","tag-trodelvy","industry-pharmaceutical","therapeutic_areas-oncology"],"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>Watch Out for Top 10 Oncology Drugs To Be Launch in 2023<\/title>\n<meta name=\"description\" content=\"Oncology drugs pipeline is also looking promising, with potential candidates such as Lynparza, Trodelvy, Glofitamab, Epcoritamab, and others.\" \/>\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\/top-10-oncology-drugs-launches-2023\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Watch Out for Top 10 Oncology Drugs To Be Launch in 2023\" \/>\n<meta property=\"og:description\" content=\"Oncology drugs pipeline is also looking promising, with potential candidates such as Lynparza, Trodelvy, Glofitamab, 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