Deciphera’s Qinlock Approved for Fourth-Line GIST Treatment by FDA

WASHINGTON, D.C., The United States – The Food and Drug Administration (FDA) approved Deciphera’s Qinlock (ripretinib) for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib (branded as “Gleevec” by Novartis in the U.S.).

Qinlock was granted Breakthrough Therapy and Fast Track designations, as well a Priority Review by the FDA, and approved under the Real-Time Oncology Review (RTOR) pilot program. Additionally, the New Drug Application (NDA) for Qinlock is part of Project Orbis, an FDA initiative providing a framework for concurrent submission and review of oncology drugs among the U.S., Canada, Australia, Switzerland, and Singapore.

Through Project Orbis, Seattle Genetics, Tukysa (tucatinib), Johnson & Johnson’s (J&J) Imbruvica (ibrutinib), and AstraZeneca’s (AZ) Calquence (acalabrutinib), among other cancer drugs, have been approved by the FDA and other participating international regulators.

According to Richard Pazdur, M.D., Director of the FDA’s Oncology Center of Excellence and acting Director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, “Despite the progress that has been made of 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 continue to progress. Today’s approval provides a new treatment option for patients who have exhausted all FDA-approved therapies for GIST.”

FDA approval was based on safety and efficacy results from INVICTUS, a pivotal Phase 3 study of Qinlock in patients with advanced GIST, and a Phase 1 study of Qinlock. Qinlock demonstrated increased median progression-free survival (PFS) and median overall survival.