Posted by Michael Wonder on 15 May 2020
FDA approves first drug for fourth-line treatment of advanced gastro-intestinal stromal tumours
15 May 2020 - Today, the U.S. FDA approved Qinlock (ripretinib) tablets as the first new drug specifically approved as a fourth-line treatment for advanced gastrointestinal stromal tumour (GIST), a type of tumour that originates in the gastro-intestinal 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.
