In a rare setback for immuno-oncology leader Keytruda (pembrolizumab), the US regulator on Wednesday rejected a bid for accelerated approval in liver cancer.
Together with Japanese drugmaker Eisai (TYO: 4523), developer Merck & Co (NYSE: MRK) had submitted a combination therapy pairing the I-O option with Lenvima (lenvatinib).
Lenvima, a multiple receptor tyrosine kinase inhibitor (TKI) marketed in Europe as Kisplyx, has been approved in this combination to treat endometrial carcinoma.
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