Deciphera's NDA For GIST Drug Gets Priority Review From FDA
Zacks Investment Research | Feb 12, 2020 10:31PM ET
Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) announced that the FDA has accepted the new drug application (NDA) for its investigational pipeline candidate ripretinib. The company is seeking approval of the candidate for treating patients with advanced gastrointestinal stromal tumors (GIST).
With the FDA granting a priority review to the NDA, a decision from the regulatory body is expected on Aug 13, 2020. Deciphera also submitted additional marketing applications for ripretinib in Canada and Australia to treat advanced GIST.
Notably, the priority review designation is granted to drugs that have the potential to provide significant improvements in the safety and effectiveness of the treatment, prevention or diagnosis of a serious disease.
Deciphera submitted the NDA to the FDA last December. The NDA was based on positive data from a pivotal phase III study named INVICTUS, which evaluated ripretinib in patients with advanced GIST.
We remind investors that in August 2019, the company announced encouraging data from the above-mentioned study evaluating ripretinib in GIST patients, previously treated with at least Novartis’ Gleevec (imatinib), Pfizer’s (NYSE:PFE) Sutent (sunitinib) and Bayer’s (OTC:BAYRY) Stivarga (regorafenib).
The study met the primary endpoint of improved progression free survival compared to placebo in patients with fourth-line or later-line setting GIST.
Shares of Deciphera have skyrocketed 148.1% in the past year against the Zacks Investment Research
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