MERCK $MRK'S SAC-TMT GETS FDA PRIORITY REVIEW, PDUFA DATE SET FOR JUNE 15, 2027
• The FDA accepted the biologics licens | Hanami
MERCK $MRK'S SAC-TMT GETS FDA PRIORITY REVIEW, PDUFA DATE SET FOR JUNE 15, 2027
• The FDA accepted the biologics license application for sacituzumab tirumotecan (sac-TMT) for priority review
• Sac-TMT reduced the risk of death by 32% and the risk of disease progression or death by 41% vs chemotherapy in certain patients with advanced or recurrent endometrial cancer
• Merck says safety was consistent with previously reported studies of sac-TMT, with no new safety signals
• Merck says it is hopeful for approval before the PDUFA date, based on discussions with the FDA