FDA Lifts Hold on BioNTech's Experimental Cancer Drug Study

The U.S. FDA has lifted a partial clinical hold on BioNTech's study of its cancer drug. The company has added risk mitigation measures per FDA's requirements. The drug, an antibody-drug conjugate, aims to target cancer cells while minimizing harm to normal cells, and is sponsored by MediLink.

The U.S. Food and Drug Administration (FDA) has lifted a partial clinical hold on BioNTech's early stage study of its experimental cancer drug, the company announced on Monday. BioNTech stated it has now included additional risk mitigation measures into the investigator brochure and patient consent forms, in line with the FDA's requirements.

The drug, an antibody-drug conjugate (ADC), is being studied in a trial sponsored by China-based MediLink, targeting patients with types of non-small cell lung cancer or breast cancer who have previously received treatment. ADCs, often referred to as "guided-missile" cancer drugs, are designed to selectively target cancer cells, potentially reducing collateral damage to normal cells.

The FDA had expressed concerns to MediLink that the drug, identified as BNT326/YL202, might pose significant risks of illness or injury at higher doses.

(With inputs from agencies.)