FDA approves first drug for 4th-line GIST treatment

The US Food and Drug Administration approved Qinlock (ripretinib) tablets as the first new drug specifically approved as a fourth-line treatment for advanced gastrointestinal stromal tumor (GIST), a type of tumor that originates in the gastrointestinal tract.

Tumor drug resistance specialist Deciphera Pharmaceuticals’ (Nasdaq: DCPH) Qinlock is indicated for adult patients who have received prior treatment with three or more kinase inhibitor therapies, including imatinib.

The FDA previously granted Breakthrough Therapy and Fast Track designations as well as Priority Review for Qinlock and reviewed the New Drug Application (NDA) under the Real-Time Oncology Review (RTOR) pilot program. The FDA approved Qinlock three months prior to the Prescription Drug User Fee Act (PDUFA) date. The Qinlock NDA is also part of Project Orbis, an initiative of the FDA Oncology Center of Excellence that provides a framework for concurrent submission and review of oncology drugs among participating international health authorities.