FDA Approves First Drug for Fourth-Line Treatment of Advance
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U.S. Food and Drug Administration approved Qinlock (ripretinib) tablets as the first new drug specifically approved as a fourth-line treatment for advanced gastrointestinal stromal tumors (GIST), a type of tumor that originates in the gastrointestinal tract.

Qinlock is indicated for adult patients who have received prior treatment with three or more kinase inhibitor therapies, including imatinib.

Qinlock’s approval was based on the results of an international, multi-center, randomized, double-blind, placebo-controlled clinical trial that enrolled 129 patients with advanced GIST who had received prior treatment with other FDA-approved targeted therapies, imatinib, sunitinib and regorafenib.

Qinlock can also cause serious side effects including skin cancer, hypertension, and cardiac dysfunction manifested as ejection fraction decrease.

The FDA granted approval of Qinlock to Deciphera Pharmaceuticals, Inc.

Source: https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-fourth-line-treatment-advanced-gastrointestinal-stromal-tumors
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