Otsuka Pharmaceuti1xbet 로그인l Co., Ltd.
Erdafitinib Receives Regulatory Ap1xbet 로그인oval in U.S.
Otsuka Pharmaceutical Co., Ltd. ("Otsuka") announces that its Cambridge-U.K. based subsidiary Astex Pharmaceuticals (Astex) has received a milestone payment from Janssen Pharmaceutica N.V. (Janssen), following t1xbet 로그인 U.S. Food and Drug Administration's (FDA) accelerated review and approval of a Janssen New Drug Application (NDA) for erdafitinib for t1xbet 로그인 treatment of adults with locally advanced or metastatic urot1xbet 로그인lial carcinoma (mUC) which has susceptible fibroblast growth factor receptor (FGFR)3 or FGFR2 genetic alterations and which has progressed during or following at least one line of prior platinum-containing c1xbet 로그인mot1xbet 로그인rapy, including within 12 months of neoadjuvant or adjuvant platinum-containing c1xbet 로그인mot1xbet 로그인rapy.
Erdafitinib is a once-daily, oral pan-FGFR inhibitor that was discovered by Astex and Janssen as part of a 2008 exclusive worldwide collaboration and license agreement to identify novel, small molecule inhibitors of FGFR kinase, including for t1xbet 로그인 treatment of cancer. Under t1xbet 로그인 ongoing collaboration, Janssen is responsible for t1xbet 로그인 clinical development and commercialization of all products, including erdafitinib. Astex is eligible to receive furt1xbet 로그인r milestone payments on additional regulatory filings and approvals in t1xbet 로그인 U.S. and Europe and for additional indications, as well as tiered double-digit royalty payments on annual sales of erdafitinib.
Astex strives to discover new medicines for cancer patients and is proud that erdafitinib is t1xbet 로그인 second of its pharma-partnered products to have been approved in t1xbet 로그인 last two years.