Deciphera Pharmaceuticals...today announced that the European Commission (EC) has approved QINLOCK® (ripretinib) in the European Union (EU) for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with three or more kinase inhibitors, including imatinib.

...Zai Lab...an innovative commercial-stage biopharmaceutical company, and Deciphera Pharmaceuticals (NASDAQ: DCPH), a commercial-stage biopharmaceutical company developing innovative medicines to improve the lives of people with cancer, today announced that the China National Medical Products Administration (NMPA) has approved its New Drug Application (NDA) for QINLOCK® (ripretinib) for the treatment of adult patients with advanced gastrointestinal stromal tumors (GIST) who have received prior treatment with three or more kinase inhibitors, including imatinib.

...Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) today announced that the Australian Therapeutic Goods Administration (TGA) has approved QINLOCK™ (ripretinib), a switch-control tyrosine kinase inhibitor, for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib.

QINLOCK is a kinase inhibitor indicated for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib.

Gastrointestinal Stromal Tumors: Fourth-line therapy (progressive disease after imatinib, sunitinib, and regorafenib)…Preferred Regimens…Ripretinib (category 1)...

PRO assessments in the INVICTUS trial suggest that patients on ripretinib maintain their QoL out to C2D1, unlike patients receiving placebo. Longitudinal QoL was maintained for patients receiving ripretinib out to cycle 10, day 1 (approximately 8 months; past the point of median progression-free survival with ripretinib [6.3 months]), even if the patients developed alopecia.

Deciphera Pharmaceuticals, Inc... today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of QINLOCK (ripretinib) for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with three or more kinase inhibitors, including imatinib....The MAA is supported by efficacy results from the pivotal Phase 3 INVICTUS study of QINLOCK in patients with advanced GIST...

Patients with advanced GIST previously treated with at least imatinib, sunitinib, and regorafenib were randomized (2:1) to ripretinib 150 mg QD or PBO….Patients randomized to ripretinib had a median PFS (mPFS) of 6.3 (95% CI 4.6−8.1) vs. 1.0 (95% CI 0.9−1.7) months for patients on PBO with a hazard ratio (HR) of 0.16.

129 pts were randomized as ITT. In the double-blind period, ripretinib improved median PFS over P (6.3 v 1 mo; HR = 0.15; 95%CI: 0.09,0.25; P < 0.0001). PFS rates at 6 mo were 51% (95%CI: 39.4,61.4) for ripretinib and 3.2% (95%CI: 0.2,13.8) for P. Analysis of PFS in pt subgroups assessed favored ripretinib. ORR was 9.4% for ripretinib and 0% for P (P = 0.0504; median duration not reached). Ripretinib demonstrated an improvement over P in median OS (15.1 v 6.6 mo; HR = 0.36; 95%CI: 0.20,0.62; nominal P = 0.0004). OS rates at 12 mo were 65.4% (95%CI: 51.6,76.1) for ripretinib and 25.9% (95%CI: 7.2,49.9) for P. Ripretinib was generally well tolerated.