Seattle Genetics/Astellas win priority US review for armed antibody aimed at bladder cancer
Seattle Genetics has secured a speedy review of its second armed antibody, courtesy of the FDA.
The company’s ‘breakthrough’ Astellas-partnered drug — enfortumab vedotin — has procured priority review from the US regulator, after data showed it helped patients with a stubborn type of bladder cancer.
The drug-induced a 44% objective response rate (ORR) in 128 patients whose disease had progressed despite treatment with both platinum-containing chemotherapy and a checkpoint inhibitor in the one-arm EV-201 study. About 12% of the patients experienced a complete response, Seattle Genetics disclosed at ASCO this June.
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