FDA expands approval of Bayer, Onyx’s Stivarga for GIST

The FDA announced Monday that it expanded approval of Bayer and Onyx’s Stivarga (regorafenib) to include the treatment of patients with advanced gastrointestinal stromal tumours (GISTs) that cannot be surgically removed and no longer respond to prior treatment. The expanded indication was approved under the agency's priority review programme.

The approval was based on data from a clinical study, which included 199 patients with GISTs that could not be surgically removed and whose disease had progressed despite prior treatment with Novartis' Gleevec (imatinib) or Pfizer's Sutent (sunitinib). In the trial, patients in the Stivarga arm had a progression-free survival of 4.8 months, compared to 0.9 months for patients receiving placebo. No significant difference in overall survival was observed between the arms because patients in the placebo arm were permitted to switch to Stivarga after disease progression was observed.

The drug was approved in September of last year to treat patients with metastatic colorectal cancer whose disease has progressed after standard therapy.

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