FDA Approves Deciphera Pharmaceuticals’ Drug for Fourth-Line Treatment of Advanced Gastrointestinal Stromal Tumors
Deciphera Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration (FDA) has approved QINLOCK (ripretinib) 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.
“Despite the progress that has been made over the past 20 years in developing treatments for GIST, including four FDA-approved targeted therapies – imatinib in 2002, sunitinib in 2006, regorafenib in 2013 and avapritinib earlier this year – some patients don’t respond to treatment and their tumors continues to progress. Today’s approval provides a new treatment option for patients who have exhausted all FDA-approved therapies for GIST,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research.
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 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. QINLOCK targets the broad spectrum of KIT and PDGFRα mutations known to drive GIST.
"Today’s approval of QINLOCK establishes a new standard of care for patients who have received three prior therapies,” said Margaret von Mehren, MD, Chief of Sarcoma Oncology and Associate Director for Clinical Research, Fox Chase Cancer Center, Philadelphia, Pennsylvania. “GIST is a complex disease and the majority of patients who initially respond to traditional tyrosine kinase inhibitors eventually develop tumor progression due to secondary mutations. In the INVICTUS study, QINLOCK has demonstrated compelling clinical benefit in progression-free and overall survival. QINLOCK is well tolerated and is a crucial new therapy for these patients with a high unmet need.”
"The FDA approval of QINLOCK is an exciting milestone for people with GIST who have been waiting for a new treatment option designed specifically for their disease,” said Steve Hoerter, President and Chief Executive Officer of Deciphera. “I would like to thank the patients, their families and caregivers, and the healthcare professionals who made the QINLOCK clinical studies possible. With their contributions and the dedication of the team at Deciphera, we are delivering on our promise to provide important new medicines for the treatment of cancer.”
Deciphera Pharmaceuticals plans to make QINLOCK commercially available in the U.S. next week.
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