{"id":11770,"date":"2021-02-16T17:03:03","date_gmt":"2021-02-16T11:33:03","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=11770"},"modified":"2021-07-24T12:58:16","modified_gmt":"2021-07-24T07:28:16","slug":"pharma-happenings-in-merck-eisai-g1-therapeutics-takedas-astellas-seagen","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/pharma-happenings-in-merck-eisai-g1-therapeutics-takedas-astellas-seagen","title":{"rendered":"Merck, Eisai in renal cancer market;  G1 Therapeutics on Cosela\u2019s approval; Takeda&#8217;s Maribavir; Astellas\/Seagen Padcev"},"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-69dc03bb26fe8\" 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-69dc03bb26fe8\"  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-happenings-in-merck-eisai-g1-therapeutics-takedas-astellas-seagen\/#Mercks_Keytruda-Eisais_Lenvima_Combo_Make_the_Cut_in_Renal_Cancer\" >Merck&#8217;s Keytruda-Eisai&#8217;s Lenvima Combo Make the Cut in Renal Cancer<\/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-happenings-in-merck-eisai-g1-therapeutics-takedas-astellas-seagen\/#G1_Therapeutics_shares_shoot_up_after_FDA_Oked_Cosela\" >G1 Therapeutics shares shoot up after FDA Ok\u00e9d Cosela&nbsp;<\/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-happenings-in-merck-eisai-g1-therapeutics-takedas-astellas-seagen\/#AstellasSeagen_gears_up_for_US_filing_of_bladder_cancer_drug_Padcev\" >Astellas\/Seagen gears up for US filing of bladder cancer drug Padcev<\/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-happenings-in-merck-eisai-g1-therapeutics-takedas-astellas-seagen\/#Takeda_wins_big_in_cytomegalovirus_infection_market\" >Takeda wins big in cytomegalovirus infection market&nbsp;<\/a><\/li><\/ul><\/nav><\/div>\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Mercks_Keytruda-Eisais_Lenvima_Combo_Make_the_Cut_in_Renal_Cancer\"><\/span><strong>Merck&#8217;s Keytruda-Eisai&#8217;s Lenvima Combo Make the Cut in Renal Cancer<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Numerous immunotherapy-based combinations are already trying in the old game of gleek to stake up some share in previously untreated, metastatic kidney cancer; however, the market seems to expand as the new entrants continue to make their entry.&nbsp;<\/p>\n\n\n\n<p>Merck and the partner Eisai presented investigational data from the pivotal Phase III <strong>CLEAR <\/strong>study (KEYNOTE-581\/Study 307) evaluating <strong>Keytruda <\/strong>and <strong>Lenvima <\/strong>combination. The results demonstrated statistically significant and clinically meaningful improvements in progression-free survival (PFS) in first-line <a href=\"https:\/\/www.delveinsight.com\/report-store\/advanced-renal-cell-carcinoma-rcc-market?utm_source=blog&amp;utm_medium=news&amp;utm_campaign=v\" target=\"_blank\" rel=\"noreferrer noopener\">advanced renal cell carcinoma<\/a> (RCC) patients. The combo treatment also met key secondary endpoints of overall survival (OS) and objective response rate (ORR). The data was presented at the virtual 2021 Genitourinary Cancers Symposium (ASCO GU) and also published in the New England Journal of Medicine.<\/p>\n\n\n\n<p>Successful in outwinning Pfizer\u2019s Sutent, Keytruda-Lenvima duo would be up against already approved therapies such as Bristol Myers Squibb\u2019s Opdivo-Yervoy duo and even Merck\u2019s combination of Keytruda and Pfizer\u2019s Inlyta (axitinib), once approved.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"G1_Therapeutics_shares_shoot_up_after_FDA_Oked_Cosela\"><\/span><strong>G1 Therapeutics shares shoot up after FDA Ok\u00e9d Cosela&nbsp;<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The US FDA has given green-light to G1 Therapeutics\u2019 first-in-class agent <strong>Trilaciclib <\/strong>(Cosela) for the treatment of patients with extensive-stage <a href=\"https:\/\/www.delveinsight.com\/report-store\/small-cell-lung-cancer-market?utm_source=blog&amp;utm_medium=news&amp;utm_campaign=v\" target=\"_blank\" rel=\"noreferrer noopener\">small-cell lung cancer (SCLC)<\/a> to reduce chemotherapy-induced bone marrow suppression.\u00a0<\/p>\n\n\n\n<p>The approval of Cosela marks an important advancement in healthcare in patients with extensive-stage small-cell lung cancer receiving chemotherapy. Chemotherapy drugs while killing cancer cells also damages normal tissues. The bone marrow is particularly vulnerable in this case. With damages to the bone marrow, the production and normal functioning of red blood cells, white blood cells, and platelets get hampered.&nbsp;<\/p>\n\n\n\n<p>So far, the available approaches have been implementing the use of growth factor agents to accelerate blood cell recovery after the bone marrow injury has occurred, coupled with antibiotics and transfusions. However, Cosela uses a different approach by preventing the damage. The drug is the first and only therapy that is developed and approved to protect bone marrow (myeloprotection), which is injected prior to treatment with chemotherapy, asserts the US oncology drug developer, G1.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"AstellasSeagen_gears_up_for_US_filing_of_bladder_cancer_drug_Padcev\"><\/span><strong>Astellas\/Seagen gears up for US filing of bladder cancer drug Padcev<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Astellas and Seagen are now prepared to go ahead with the final approval from the regulatory agency for Padcev (enfortumab vedotin) in patients with previously treated advanced <a href=\"https:\/\/www.delveinsight.com\/report-store\/urothelial-carcinoma-market?utm_source=blog&amp;utm_medium=news&amp;utm_campaign=v\" target=\"_blank\" rel=\"noreferrer noopener\">urothelial cancer<\/a>.\u00a0<\/p>\n\n\n\n<p>Padcev is a first-in-class antibody-drug conjugate (ADC) directed against Nectin-4, a protein<\/p>\n\n\n\n<p>located on the surface of cells and highly expressed in bladder cancer. The therapy is the first therapy of its kind to target the Nectin-4 protein.<\/p>\n\n\n\n<p>Padcev was given accelerated approval by the FDA in December 2019 in advanced urothelial cancer on the basis of phase 2 response data. However, now the duo has reported positive primary results from the phase 3 EV-301 trial comparing Padcev to chemotherapy and are positive about receiving FDA affirmation.&nbsp;<\/p>\n\n\n\n<p>The companies will now plan to move forward with the evaluation of drugs in other cancers with high expression of NECTIN-4, including triple-negative breast cancer, non-small cell lung cancer, head and neck, and certain types of gastro-oesophageal cancer.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Takeda_wins_big_in_cytomegalovirus_infection_market\"><\/span><strong>Takeda wins big in cytomegalovirus infection market&nbsp;<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Takeda has announced new, late-breaking Phase 3 data from the TAK-620-303 (SOLSTICE) trial, for the investigational drug TAK-620 (maribavir) in transplant recipients with refractory, with or without resistance (R\/R), <a href=\"https:\/\/www.delveinsight.com\/report-store\/cytomegalovirus-cmv-infection-market?utm_source=blog&amp;utm_medium=news&amp;utm_campaign=v\" target=\"_blank\" rel=\"noreferrer noopener\">cytomegalovirus (CMV) infection\/disease<\/a>.\u00a0<\/p>\n\n\n\n<p>Maribavir is an orally bioavailable anti-CMV compound. It is the only antiviral agent in Phase 3 development for the treatment of post-transplant patients with CMV in SOT or HCT that targets and inhibits the UL97 protein kinase and its natural substrates.<\/p>\n\n\n\n<p>The therapy met its primary endpoint of superiority compared to conventional antiviral therapies, one or a combination of ganciclovir, valganciclovir, foscarnet, or cidofovir), suggesting maribavir is better at eliminating the virus from the blood than existing treatments such as ganciclovir and valganciclovir. Although <a href=\"https:\/\/www.delveinsight.com\/blog\/cytomegalovirus-cmv-infection-market-outlook\/?utm_source=blog&amp;utm_medium=news&amp;utm_campaign=v\" target=\"_blank\" rel=\"noreferrer noopener\">cytomegalovirus infections<\/a> are quite common and do not cause many symptoms, however, can be threatening in people with compromised immune systems.<\/p>\n\n\n\n<p>The drug started its journey with GSK who evaluated its pre-clinical setting and out-licensed it to ViroPharma. ViroPharma led the drug through phase II; however, eventually passed it down to Shire (acquired by Takeda now). It is about time now that the drug reaches its goal.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Merck&#8217;s Keytruda-Eisai&#8217;s Lenvima Combo Make the Cut in Renal Cancer Numerous immunotherapy-based combinations are already trying in the old game of gleek to stake up some share in previously untreated, metastatic kidney cancer; however, the market seems to expand as the new entrants continue to make their entry.&nbsp; Merck and the partner Eisai presented investigational [&hellip;]<\/p>\n","protected":false},"author":14,"featured_media":11772,"comment_status":"open","ping_status":"open","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":[17],"tags":[3452,554,16888],"industry":[17225],"therapeutic_areas":[17229,17230,17233,17228,17278],"class_list":["post-11770","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-articles","tag-renal-carcinoma","tag-takeda","tag-urothelial-cancer","industry-pharmaceutical","therapeutic_areas-central-nervous-system","therapeutic_areas-genito-urinary-system-and-sex-hormones","therapeutic_areas-hematological-disorders","therapeutic_areas-oncology","therapeutic_areas-other-diseases"],"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>Approvals for Merck, Eisai, G1 therapeutics, Takeda, Astellas\/Seagen<\/title>\n<meta name=\"description\" content=\"Merck, Eisai in renal cancer market; 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