Deciphera Pharmaceuticals, Inc. DCPH announced that the FDA has approved its kinase inhibitor Qinlock (ripretinib) for treating patients with advanced gastrointestinal stromal tumors (GIST) who were already treated with three or more kinase inhibitors including Novartis’ NVS Gleevec (imatinib).
In February 2020, the FDA accepted the new drug application (NDA) for Qinlock to treat patients with fourth-line GIST. In December 2019, the NDA application was filed for the same.
In August last year, the company announced encouraging data from the INVICTUS study evaluating Qinlock in GIST patients, previously treated with at least Novartis’ Gleevec, Pfizer’s PFE Sutent (sunitinib) and Bayer’s BAYRY Stivarga (regorafenib).
Shares of Deciphera have declined 10.4% so far this year against the industry’s increase of 7.7%.
We note that the approval comes three months before the scheduled Prescription Drug User Fee Act (PDUFA) action date of Aug 13, 2020. The NDA for Qinlock was also granted Breakthrough Therapy and Fast Track designations as well as a priority review under the Real-Time Oncology Review pilot program of the FDA.
Per the company, this approval was based on the efficacy data from the pivotal phase III INVICTUS study as well as the combined safety results from INVICTUS and the phase I study on Qinlock in patients with advanced GIST. Outcomes of the study showed that treatment with Qinlock led to a median progression-free survival of 6.3 months compared to one month in the placebo arm. Findings also reflect a significant reduction in the risk of disease progression or death by 85%.
Moreover, Qinlock demonstrated a median overall survival of 15.1 months compared to 6.6 months in the placebo arm, thereby reducing the risk of death by 64%.
The company plans to launch the drug shortly in the United States.
Deciphera currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Today's Best Stocks from Zacks
Would you like to see the updated picks from our best market-beating strategies? From 2017 through 2019, while the S&P 500 gained and impressive +53.6%, five of our strategies returned +65.8%, +97.1%, +118.0%, +175.7% and even +186.7%.
This outperformance has not just been a recent phenomenon. From 2000 – 2019, while the S&P averaged +6.0% per year, our top strategies averaged up to +54.7% per year.
See their latest picks free >>
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Pfizer Inc. (PFE) : Free Stock Analysis Report
Novartis AG (NVS) : Free Stock Analysis Report
Bayer Aktiengesellschaft (BAYRY) : Free Stock Analysis Report
Deciphera Pharmaceuticals, Inc. (DCPH) : Free Stock Analysis Report
To read this article on Zacks.com click here.
Zacks Investment Research