Merck says FDA accepts priority review for SAC-TMT biologics license application
MRK•The FDA accepted priority review of Merck’s SAC-TMT biologics license application and set a June 15, 2027, target action date. In certain patients with advanced or recurrent endometrial cancer, SAC-TMT reduced the risk of death by 32% and the risk of progression or death by 41% compared with chemotherapy.
1. Priority review accepted
Merck said the FDA accepted priority review of its biologics license application for sacituzumab tirumotecan, or SAC-TMT, and set a June 15, 2027, target action date. The company said it is hopeful for approval before that date based on discussions with the FDA.
2. Trial results and safety
In certain patients with advanced or recurrent endometrial cancer, SAC-TMT reduced the risk of death by 32% and the risk of disease progression or death by 41% compared with chemotherapy. Merck said the safety profile was consistent with previously reported studies and that no new safety signals were observed.
