GDANSK, Aug 19 (Reuters) - BioNTech on Monday
said the U.S. Food and Drug Administration (FDA) has lifted a
partial clinical hold on an early stage study of its
experimental cancer drug.
The company has now included additional risk mitigation
measures into investigator brochure and consent for patients, in
line with the FDA's requirements, BioNTech said.
The drug, an antibody-drug conjugate (ADC), was being
studied in a trial sponsored by China-based MediLink, in
patients with types of non-small cell lung cancer or breast
cancer who have received prior forms of treatment.
ADCs, often described as "guided-missile" cancer drugs, are
designed to target only cancer cells, unlike conventional
chemotherapy, potentially reducing damage to normal cells.
The U.S. health regulator has shared with MediLink concerns
that the drug, BNT326/YL202, may, at higher doses, expose humans
to an unreasonable and significant risk of illness or injuries.