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Deciphera files for US FDA approval of gastrointestinal tumor drug


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Deciphera files for US FDA approval of gastrointestinal tumor drug

Deciphera Pharmaceuticals Inc. has applied to the U.S. Food and Drug Administration seeking approval of ripretinib to treat certain patients with gastrointestinal tumors.

The Waltham, Mass.-based biotechnology company filed a new drug application for ripretinib to treat patients with advanced gastrointestinal stromal tumors who did not respond to prior treatments. Deciphera tested its therapy against Novartis AG's Gleevec, or imatinib; Pfizer Inc.'s Sutent, also known as sunitinib; and Bayer AG's Stivarga, or regorafenib.

A gastrointestinal stromal tumor is a type of tumor that occurs in the gastrointestinal tract, mostly in the stomach or small intestine. These tumors may be cancerous or benign.

Deciphera said in a Dec. 16 press release that the filing was backed by data from a phase 3 trial, dubbed Invictus, which showed that patients on the drug lived longer without their disease worsening or death, compared to patients on placebo.

The company said the FDA is reviewing the application under the Oncology Center of Excellence Real-Time Oncology Review, a pilot program that aims to provide a more efficient review process to make treatments available to patients as early as possible.

Ripretinib received the FDA's breakthrough-therapy designation for advanced gastrointestinal stromal tumors in October.