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Deciphera's NDA for GIST Drug Gets Priority Review From FDA

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Deciphera Pharmaceuticals, Inc. 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 PFE Sutent (sunitinib) and Bayer’s 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 industry’s decline of 2.5%.

Apart from GIST, ripretinib, a KIT and PDGFRα inhibitor, is also being developed for systemic mastocytosis (SM) and other type of cancers.

However, if approved, ripretinib is likely to face competition from Blueprint Medicines’ (BPMC - Free Report) newly approved product, Ayvakit (avapritinib). The drug was approved by the FDA last month for the treatment of unresectable or metastatic GIST, harboring a PDGFRA exon 18 mutation including PDGFRA D842V mutations in adults. Ayvakit is also under review for fourth-line GIST in the United States with a decision from the FDA expected on May 14, 2020.

Blueprint Medicines is also developing Ayvakit for the advanced, indolent and smoldering forms of SM.

Zacks Rank

Deciphera currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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