FDA approves ripretinib as fourth-line treatment for GIST

The FDA has approved ripretinib tablets for the treatment of advanced gastrointestinal stromal tumor, or GIST, in the fourth-line setting.

Ripretinib (Qinlock; Deciphera Pharmaceuticals, Inc.) is the first new drug specifically approved for fourth-line treatment of GIST. It was approved for use in adult patients who have been treated previously with three or more kinase inhibitor therapies, including imatinib, according to the FDA.

The approval was based on data from the phase 3 INVICTUS study, which evaluated the impact of ripretinib compared with placebo on PFS among patients with advanced GIST who had received prior treatment with imatinib, sunitinib (Sutent, Pfizer) and regorafenib (Nexavar, Bayer). According to a press release on the approval, average PFS in patients who received ripretinib was 6.3 months compared with 1 month for patients who received placebo.

The most commonly reported side effects in the ripretinib arm included alopecia, fatigue, nausea, abdominal pain, constipation, myalgia, diarrhea, decreased appetite, palmar-plantar erythrodysesthesia syndrome and vomiting.

GIST, a tumor that originates in the gastrointestinal tract, is diagnosed in approximately 4,000 to 6,000 adults In the United States each year.

“Despite the progress that has been made over the past 20 years in developing treatments for GIST, including four FDA-approved targeted therapies, some patients don’t respond to treatment and their tumors continues to progress,” Richard Pazdur, 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 the release. “Today’s approval provides a new treatment option for patients who have exhausted all FDA-approved therapies for GIST.”