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Where Next For Sesen Bio’s Bladder Cancer Therapy Vicineum?

First-Mover Hopes Dashed By CRL

 
• By Sten Stovall

A complete response letter from the FDA has dashed Sesen Bio’s hopes of being first with a therapy for treating BCG-unresponsive non-muscle invasive bladder cancer. Its CEO says the FDA’s move may reflect heightened ‘pressure’ regulator is under.  

CRL came just days before priority review target PDUFA date of 18 August. • Source: Alamy

Sesen Bio, Inc. hopes to meet with US regulators as soon as possible to try and reinflate approval prospects for its lead investigational therapy, Vicineum, after the biotech received a complete response letter from the US Food and Drug Administration for the therapy’s use in BCG-unresponsive non-muscle invasive bladder cancer. The surprize setback seems to have dashed the drug’s chances of gaining first-mover status in the NMIBC market and address the high unmet medical need there.

Sesen surprized investors on 13 August by announcing receipt of the CRL following a priority review, just ahead of its PDUFA action date of 18 August, causing the biotech’s stock sink

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