Deciphera gets Qinlock FDA approval for fourth-line advanced GIST

Qinlock FDA approval : Deciphera Pharmaceuticals has been granted approval from the US Food and Drug Administration (FDA) for Qinlock (ripretinib) in advanced gastrointestinal stromal tumor (GIST) in adult patients who had prior treatment with three or more kinase inhibitors, including imatinib.

The decision from the FDA marks Qinlock as the first drug approved in the US for the fourth-line treatment for advanced gastrointestinal stromal tumor, a type of tumor that begins in the gastrointestinal tract. As per the FDA, these tumors most often occur in the stomach, small intestine, and large intestine but can begin anywhere along the gastrointestinal tract.

Qinlock is a kinase inhibitor which functions by inhibiting an enzyme called a kinase, which helps in preventing the cancer cells from growing.

Deciphera Pharmaceuticals bagged the Qinlock FDA approval based on the findings of the phase 3 INVICTUS clinical trial featuring 120 patients with advanced gastrointestinal stromal tumor,  who were given prior treatment with other FDA-approved targeted therapies – imatinib, sunitinib, and regorafenib.

In the INVICTUS clinical trial, the kinase inhibitor from Deciphera Pharmaceuticals showed a median progression-free survival of 6.3 months. This is in comparison to 1.0 month in the placebo group.

Qinlock also considerably reduced the risk of disease progression or death by 85% in the phase 3 clinical trial. Additionally, the kinase inhibitor delivered a median overall survival of 15.1 months compared to 6.6 months in the placebo group, while reducing the risk of death by 64%.

Deciphera bags Qinlock FDA approval for fourth-line treatment of advanced GIST. Photo courtesy of The U.S. Food and Drug Administration/Wikipedia.org.

Commenting on Qinlock FDA approval, Steve Hoerter – President and CEO of Deciphera Pharmaceuticals said: “The FDA approval of QINLOCK is an exciting milestone for people with GIST who have been waiting for a new treatment option designed specifically for their disease.”

Previously, the kinase inhibitor was given FDA’s breakthrough therapy and fast track designations. It was also granted FDA priority review under the Real-Time Oncology Review (RTOR) pilot program.

Richard Pazdur – director of the FDA Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA Center for Drug Evaluation and Research, commenting on Qinlock FDA approval, said: “Despite the progress that has been made over the past 20 years in developing treatments for GIST, including four FDA-approved targeted therapies – imatinib in 2002, sunitinib in 2006, regorafenib in 2013 and avapritinib earlier this year – some patients don’t respond to treatment and their tumors continues to progress. Today’s approval provides a new treatment option for patients who have exhausted all FDA-approved therapies for GIST.”