FDA approval for Ripretinib in fourth-line GIST
The company Deciphera Pharmaceuticals announced on May 15 that the U.S. FDA has approved Ripretinib (brandname Quinlock™) 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.
“Today’s approval of Ripretinib 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, Ripretinib has demonstrated compelling clinical benefit in progression-free and overall survival. Ripretinib is well tolerated and is a crucial new therapy for these patients with a high unmet need.”
The FDA approval of Ripretinib is indeed an exciting milestone for people with GIST who have been waiting for a new treatment option designed specifically for their disease. The FDA approval was based on efficacy results from the pivotal Phase III INVICTUS study of Ripretinib in patients with advanced GIST as well as combined safety results from INVICTUS and the Phase I study of Ripretinib. In INVICTUS, Ripretinib 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<0.0001). In addition, Ripretinib demonstrated a median overall survival of 15.1 months compared to 6.6 months in the placebo arm and reduced the risk of death by 64% (hazard ratio of 0.36).
For more information, please visit the FDA-Website (Under “View full prescribing information for QINLOCK” you can download a PDF)
Further information about the INVICTUS study can be accessed here: invictus: DCC-2618 vs. placebo in advanced pre-treated GIST patients