ARTICLE | Regulation
Fourth-line GIST showdown ends in an FDA win for Deciphera, a rejection for Blueprint
Blueprint drug denied in the same indication, and Clovis’ PARP inhibitor gains approval in prostate cancer
May 15, 2020 11:52 PM UTC
Updated on May 15, 2020 at 11:54 PM UTC
FDA approved Qinlock repretinib from Deciphera as fourth-line treatment for advanced gastrointestinal stromal tumors (GIST), marking the first approved therapy for the indication. Also on Friday, competitor Blueprint said FDA issued a complete response letter for Ayvakit avapritinib in fourth-line GIST, as expected.
Deciphera Pharmaceuticals Inc. (NASDAQ:DCPH) plans to launch Qinlock in the U.S. next week. The pan-c-Kit and PDGFRA inhibitor is indicated for patients who have received prior treatment with three or more kinase inhibitors, including imatinib. ...
BCIQ Company Profiles