GDANSK (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.
(Reporting by Ludwig Burger, writing by Andrey Sychev, editing by Miranda Murray)
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