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BioNTech says FDA lifts partial hold on its cancer drug trial
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BioNTech says FDA lifts partial hold on its cancer drug trial
Aug 19, 2024 4:10 AM

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.

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