Health
AB Science: Masitinib receives FDA and EMA authorization for confirmatory phase 3 trial in metastatic castrate-resistant prostate cancer
PRESS RELEASE MASITINIB RECEIVES FDA AND EMA AUTHORIZATION FOR CONFIRMATORY PHASE 3 TRIAL IN METASTATIC CASTRATE-RESISTANT PROSTATE CANCER, WITH BIOMARKER-DRIVEN PATIENT SELECTION TARGETING POPULATION MOST LIKELY TO BENEFIT Paris, July 4, 2025, 8am CET AB Science SA (Euronext - FR0010557264 - AB) today announced that a confirmatory phase 3 trial of masitinib in metastatic castrate resistant prostate cancer (study AB22007) has been authorized by FDA and EMA (harmonized protocol approved through s
About this update from Ab Science Sa
[{"type":"image","alt":"AB Science","displaySize":"","headline":null,"caption":"AB Science","className":"","disableSlideshowImg":false,"size":{"original":{"width":156,"height":160,"url":"https://media.zenfs.com/en/globenewswire.com/7964f89fed41da51df043a8d3708bbe2"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/AW2UM4sIueJ.X0XSJNjHhQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTIxMDtoPTIxNTtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/7964f89fed41da51df043a8d3708bbe2","width":156,"height":160}},"lazy":false},{"type":"text","content":"PRESS RELEASE","length":13,"tagName":"p"},{"type":"text","content":"MASITINIB RECEIVES FDA AND EMA AUTHORIZATION FOR CONFIRMATORY PHASE 3 TRIAL IN METASTATIC CASTRATE-RESISTANT PROSTATE CANCER, WITH BIOMARKER-DRIVEN PATIENT SELECTION TARGETING POPULATION MOST LIKELY TO BENEFIT","length":209,"tagName":"p"},{"type":"text","content":"Paris, July 4, 2025, 8am CET","length":28,"tagName":"p"},{"type":"text","content":"AB Science SA (Euronext - FR0010557264 - AB) today announced that a confirmatory phase 3 trial of masitinib in metastatic castrate resistant prostate cancer (study AB22007) has been authorized by FDA and EMA (harmonized protocol approved through step 1 of Clinical Trials Information System), with a biomarker that targets patients with less advanced metastatic disease.","length":370,"tagName":"p"},{"type":"text","content":"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.”","length":487,"tagName":"p"},{"type":"list","items":[{"val":[{"type":"text","content":"Design of phase 3 study","length":23,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":23,"olType":false},{"type":"text","content":"Study AB22007 is a prospective, multicenter, randomized, double blind, placebo-controlled, 2-parallel groups, phase 3 study to confirm the efficacy and safety of docetaxel (IV 75 mg/m² plus prednisone for up to 10 cycles) plus masitinib 6.0 mg/kg/d, versus docetaxel plus placebo in metastatic cas...