AB Science SA Receives FDA and EMA Authorization for Phase 3 Trial of Masitinib in Metastatic Castrate-Resistant Prostate Cancer

Reuters
2025/07/04
AB Science SA Receives FDA and EMA Authorization for Phase 3 Trial of Masitinib in Metastatic Castrate-Resistant Prostate Cancer

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.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. AB Science SA published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW1001116384-en) on July 04, 2025, and is solely responsible for the information contained therein.

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