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FDA Approves Ripretinib for Advanced GIST

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The U.S. Food and Drug Administration (FDA) has approved ripretinib (Qinlock) tablets as a fourth-line treatment for advanced gastrointestinal stromal tumor (GIST), indicated for adult patients who have received prior treatment with ≥3 kinase inhibitor therapies.

“Despite the progress that has been made over the past 20 years in developing treatments for GIST, including 4 FDA-approved targeted therapies — imatinib in 2002, sunitinib (Sutent) in 2006, regorafenib (Stivarga) in 2013, and avapritinib (Ayvakit) earlier this year — some patients don’t respond to treatment and their tumors continues to progress,” Richard Padzur, MD, 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, said in a press release. “Today’s approval provides a new treatment option for patients who have exhausted all FDA-approved therapies for GIST.”

Read the full press release here.

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