Second approval for Deciphera's GIST drug Qinlock

Marking a second for the product, Health Canada has authorized Qinlock (ripretinib), a switch-control tyrosine kinase inhibitor, for sale in Canada for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with imatinib, sunitinib, and regorafenib, says US tumor drug resistance specialist Deciphera Pharmaceuticals (Nasdaq: DCPH), whose share closed up 3.7% at $65.03 following the news yesterday.

The Qinlock New Drug Submission was approved by Health Canada under Project Orbis, an initiative of the US Food and Drug Administration’s Oncology Center of Excellence designed to provide a framework for concurrent submission and review of oncology products among international partners. In May 2020, Qinlock was approved by the US FDA for the treatment of adult patients with advanced GIST who have received prior treatment with three or more kinase inhibitors, including imatinib.

Ahead of the US approval as the first new drug specifically approved as a fourth-line treatment for advanced gastrointestinal stromal tumor (GIST, analysts had forecast the therapy could bring in as much as $700 million for the firm by 2024.