Policy & Regulation
Deciphera Receives European Commission Approval of Qinlock for the Treatment of Fourth-Line Gastrointestinal Stromal Tumor
24 November 2021 - - The European Commission has approved Qinlock (ripretinib) in the European Union for the treatment of adult patients with advanced gastrointestinal stromal tumor who have received prior treatment with three or more kinase inhibitors, including imatinib, US-based biopharmaceutical company Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH) said.

The EC decision is applicable to all 27 European Union member states plus Iceland, Norway, and Liechtenstein.

In September 2021, Qinlock was added as a fourth-line treatment for GIST patients progressing or intolerant to imatinib, sunitinib, and regorafenib to the ESMO-EURACAN-GENTURIS clinical practice guidelines for GIST2.

The Qinlock approval was supported by efficacy results from the primary analysis of the pivotal Phase 3 INVICTUS study in patients with advanced GIST as well as combined safety results from INVICTUS and the Phase 1 study of Qinlock.

In INVICTUS, Qinlock demonstrated a median progression-free survival of 6.3 months compared to 1.0 month in the placebo arm and significantly reduced the risk of disease progression or death by 85% (hazard ratio of 0.15, p
Login
Username:

Password:


Related Headlines