AB Science SA has announced that its confirmatory phase 3 trial of masitinib for the treatment of metastatic castrate-resistant prostate cancer (mCRPC) has received authorization from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency $(EMA)$. The trial, known as study AB22007, will focus on patients with less advanced metastatic disease, using a biomarker to guide patient selection. This marks a significant milestone for AB Science, as the trial could establish the first targeted combination treatment with docetaxel for mCRPC in nearly two decades. The study is designed as a multicenter, randomized, double-blind, placebo-controlled trial to confirm the efficacy and safety of masitinib in combination with docetaxel. The European Patent Office has granted a patent providing protection until 2042 for masitinib in treating mCRPC, with additional patent applications filed in other major markets, including the U.S.
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