Benzinga | Jul 14, 2020 07:08AM EDT

Deciphera Announces Australian Therapeutic Goods Administration Approval Of QINLOCK For Treatment Of Fourth-Line Gastrointestinal Stromal Tumor

- QINLOCK is the First Approved Tyrosine Kinase Inhibitor Designed Specifically for GIST Regardless of Patients' Mutational Status -

- QINLOCK Approved via the U.S. FDA's Project Orbis Initiative -

WALTHAM, Mass.--(BUSINESS WIRE)-- Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) today announced that the Australian Therapeutic Goods Administration (TGA) has approved QINLOCK(tm) (ripretinib), a switch-control tyrosine kinase inhibitor, 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. The QINLOCK Marketing Authorisation Application was approved by the TGA under Project Orbis, an initiative of the U.S. Food and Drug Administration's (FDA) Oncology Center of Excellence designed to provide a framework for concurrent submission and review of oncology products among international partners. QINLOCK is also approved by the U.S. FDA for the treatment of adult patients with advanced GIST who have received prior treatment with 3 or more kinase inhibitors, including imatinib, and authorized by Health Canada for the treatment of adult patients with advanced GIST who have received prior treatment with imatinib, sunitinib, and regorafenib.

"We would like to thank the team at the Therapeutic Goods Administration for their collaboration in the review and approval of QINLOCK in Australia," said Steve Hoerter, President and Chief Executive Officer of Deciphera. "We believe that QINLOCK has the potential to transform the GIST treatment landscape and are committed to ensuring its global commercial availability."

The TGA's approval was based on efficacy results from the pivotal global Phase 3 INVICTUS study of QINLOCK in patients with advanced GIST as well as combined safety results from INVICTUS and the Phase 1 study of QINLOCK. In INVICTUS, QINLOCK demonstrated a median progression-free survival of 6.3 months compared to 1.0 month in the placebo arm and significantly reduced the risk of disease progression or death by 85% (hazard ratio of 0.15, p<0.0001). In addition, QINLOCK demonstrated a median overall survival of 15.1 months compared to 6.6 months in the placebo arm and reduced the risk of death by 64% (hazard ratio of 0.36).

The most common adverse reactions (?20%) were alopecia, fatigue, nausea, abdominal pain, constipation, myalgia, diarrhea, decreased appetite, palmar-plantar erythrodysesthesia syndrome (PPES), and vomiting. Adverse reactions resulting in permanent discontinuation occurred in 8% of patients, dosage interruptions due to an adverse reaction occurred in 24% of patients and dose reductions due to an adverse reaction occurred in 7% of patients who received QINLOCK.