The US Food and Drug Administration (FDA) has accepted under priority review a filing from Merck, Sharp & Dohme (MSD; NYSE: MRK) and Daiichi Sankyo (TYO: 4568) for their jointly developed antibody-drug conjugate (ADC) patritumab deruxtecan. The treatment is intended for patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received two or more prior systemic therapies. The FDA has set a target action date of June 26, 2024, for its decision.
The submission is backed by data from a Phase II study, which demonstrated that the potential first-in-class HER3-directed drug achieved an objective response rate (ORR) of 29.8% and a median duration of response (DOR) of 6.4 months.- Flcube.com
