AB Science Secures Dual Regulatory Approvals From U.S. FDA And EMA To Advance Masitinib Into Phase 3 For Late-Stage Prostate Cancer

AB Science SA has received authorization from both the U.S. FDA and the European Medicines Agency (EMA) to begin a confirmatory Phase 3 trial (study AB22007) of its drug masitinib for treating metastatic castrate-resistant prostate cancer. The trial will follow a harmonized protocol approved through Step 1 of the Clinical Trials Information System (CTIS). This study will use a specific biomarker to select patients with less advanced forms of metastatic disease, allowing for more targeted and potentially effective treatment.

Professor Olivier Hermine, MD, President of the Scientific Committee of AB Science and member of the Académie des Sciences in France said, “The authorization of our confirmatory Phase 3 study by both the FDA and EMA represents a critical milestone for masitinib in metastatic castrate-resistant prostate cancer. With a validated biomarker guiding patient selection, this trial has the potential to establish the first targeted combination with docetaxel in nearly two decades for mCRPC.”