{"id":3836,"date":"2020-04-30T09:42:27","date_gmt":"2020-04-30T09:42:27","guid":{"rendered":"http:\/\/maadhouze.com\/?p=3836"},"modified":"2020-04-30T09:42:27","modified_gmt":"2020-04-30T09:42:27","slug":"takeda-announces-u-s-fda-breakthrough-therapy-designation-for-mobocertinibtak-788-for-the-treatment-of-nsclc-patients-with-egfr-exon-20-insertion-mutations","status":"publish","type":"post","link":"https:\/\/theblogonline.com\/?p=3836","title":{"rendered":"Takeda Announces U.S. FDA Breakthrough Therapy Designation For Mobocertinib(TAK-788) For The Treatment Of NSCLC Patients With EGFR Exon 20 Insertion Mutations"},"content":{"rendered":"

Takeda Pharmaceutical Company Limited (<\/span><\/span>TSE:4502\/NYSE:TAK<\/span><\/span><\/a>) (\u201cTakeda\u201d) today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for its investigational drug <\/span><\/span>mobocertinib<\/span><\/span> (TAK-788) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy. There are currently no approved therapies designed to treat this specific form of NSCLC. <\/span><\/span>Mobocertinib<\/span><\/span> is a small-molecule tyrosine kinase inhibitor (TKI) designed to selectively target EGFR and human EGFR 2 (HER2) exon 20 insertion mutations.<\/span><\/span><\/p>\n

The Breakthrough Therapy Designation is based on the overall response rate (ORR) and the long-term benefit seen in patients who responded in a Phase 1\/2 study evaluating the safety and efficacy of <\/span><\/span>mobocertinib<\/span><\/span> in patients with locally advanced or metastatic NSCLC whose tumors harbor EGFR exon 20 insertion mutations and have been previously treated with systemic chemotherapy. This signals a potential advancement in addressing the needs of patients for whom no targeted therapies exist and current treatment options provide limited benefit. <\/span><\/span><\/p>\n

\u201cWe are pleased that the FDA has recognized the therapeutic potential <\/span><\/span>mobocertinib<\/span><\/span> offers for patients with EGFR exon 20 <\/span><\/span>insertion-mutant<\/span><\/span> NSCLC who are desperately in need of effective treatment options,\u201d said Christopher Arendt, Head, Oncology Therapeutic Area Unit, Takeda. \u201cAt Takeda, we are committed to developing novel medicines for hard-to-treat diseases. Establishing Breakthrough Therapy Designation for <\/span><\/span>mobocertinib<\/span><\/span> is one step forward in our efforts to help change the current standard of care for this underserved population.\u201d <\/span><\/span><\/p>\n

\u201cAlthough most EGFR mutations can be targeted by currently available TKIs, people with exon 20 insertion mutations often suffer and feel forgotten since available EGFR inhibitors don\u2019t work well in their cancer,\u201d said Jill Feldman, Lung Cancer Patient, Advocate, and Co-Founder of the EGFR Resisters. \u201cWe are excited by the potential this treatment has to extend the lives of people who have had no approved treatment options to target their disease.\u201d <\/span><\/span><\/p>\n

Breakthrough Therapy Designation from the U.S. FDA is granted to accelerate the development and regulatory review of investigational drugs that are intended to treat serious or life-threatening ailments. Agents with this designation have shown preliminary clinical evidence that indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. <\/span><\/span><\/p>\n

Takeda will present for the first time the development of <\/span><\/span>mobocertinib<\/span><\/span>, including the first public disclosure of the structure, during the <\/span><\/span>American Association for Cancer Research (AACR) Virtual Annual Meeting I<\/span><\/span><\/a> in a New Drugs on the Horizon <\/span><\/span>session<\/span><\/span><\/a> on Tuesday, April 28, from 11:14-11:34 a.m. ET.<\/span><\/span><\/p>\n","protected":false},"excerpt":{"rendered":"

Takeda Pharmaceutical Company Limited (TSE:4502\/NYSE:TAK) (\u201cTakeda\u201d) today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for its investigational drug mobocertinib (TAK-788) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease has progressed on or after […]<\/p>\n","protected":false},"author":1,"featured_media":3837,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[2456],"tags":[2548,2550,2547,1630,2549],"class_list":["post-3836","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-business","tag-egfr-exon-20","tag-mobocertinibtak-788","tag-nsclc-patients","tag-takeda","tag-u-s-fda"],"_links":{"self":[{"href":"https:\/\/theblogonline.com\/index.php?rest_route=\/wp\/v2\/posts\/3836"}],"collection":[{"href":"https:\/\/theblogonline.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/theblogonline.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/theblogonline.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/theblogonline.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=3836"}],"version-history":[{"count":1,"href":"https:\/\/theblogonline.com\/index.php?rest_route=\/wp\/v2\/posts\/3836\/revisions"}],"predecessor-version":[{"id":3838,"href":"https:\/\/theblogonline.com\/index.php?rest_route=\/wp\/v2\/posts\/3836\/revisions\/3838"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/theblogonline.com\/index.php?rest_route=\/wp\/v2\/media\/3837"}],"wp:attachment":[{"href":"https:\/\/theblogonline.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=3836"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/theblogonline.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=3836"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/theblogonline.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=3836"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}