FDA Places Partial Hold on BioNTech's Cancer Drug Trial After Three Fatalities

Jun 17, 2024, 01:05 PM

The U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on an early-stage study of BioNTech SE's experimental cancer drug, BNT326/YL202, which is being developed in partnership with MediLink Therapeutics. The hold was prompted by safety concerns, including the risk of exposing patients to unreasonable illness or injuries. The trial, which targets breast and lung cancer, has already seen three fatalities. The FDA's decision underscores the significant safety risks associated with the high doses used in the trial. The hold was documented in a 6-K filing.