Deciphera Pharmaceuticals has been handed a priority review from the FDA for its cancer drug ripretinib.
The biotech is gunning for an FDA approval of ripretinib in patients with advanced gastrointestinal stromal tumors (GISTs). The NDA’s acceptance puts Deciphera closer to establishing ripretinib as an option for patients failed by drugs from Bayer, Novartis and Pfizer.
Ripretinib came through a phase 3 trial in fourth-line GIST patients last year, generating data to show the broad-spectrum KIT and PDGFRα inhibitor extends progression-free survival (PFS) in a group with limited options. Median PFS in the treatment group came in at 6.3 months as compared to one month in the placebo cohort.
Its filing, made in December, covers the use of ripretinib in patients previously treated with Bayer’s Stivarga, Novartis’ Gleevec and Pfizer’s Sutent. Given its speedy review, the PDUFA date for the drug is Aug. 13, though the FDA has of late been granting approvals weeks and sometimes months ahead of schedule.
The FDA is evaluating the filing under its Oncology Center of Excellence Real-Time Oncology Review (RTOR), a pilot project intended to help the agency start going over data sooner. The project enables companies to share top-line data with the FDA and, if the agency accepts them into RTOR, send presubmission data from as little as two weeks after database lock.
Officials at the FDA evaluate the presubmission data for “sufficiency and integrity” before receiving the filing for approval.
“The FDA’s acceptance of our NDA brings us one step closer to our goal of providing patients with advanced GIST a potential new treatment option,” said Steve Hoerter, president and CEO at Deciphera.
“With commercial preparations already underway, we believe we will be well positioned for a potential U.S. launch in 2020. We look forward to working with the FDA during their review of this application.”