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.
Where Next For Sesen Bio’s Bladder Cancer Therapy Vicineum?
First-Mover Hopes Dashed By CRL
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.
More from Anticancer
• By
BeiGene’s Phase III ociperlimab joins the list of failed TIGIT inhibitors, as candidates from Roche, Merck & Co. and others have failed late-stage studies.
• By
Investing heavily in antibody-drug conjugates, AbbVie is pioneering a dual STEAP1xPSMA-targeting approach in prostate cancer, as other candidates advance.
• By
Strong sales growth for the German group’s SGLT2 inhibitor in 2024
• By
A Phase III trial testing the cortisol modulator showed a benefit on PFS and OS in patients with platinum-resistant ovarian cancer.
More from Therapy Areas
• By
Investing heavily in antibody-drug conjugates, AbbVie is pioneering a dual STEAP1xPSMA-targeting approach in prostate cancer, as other candidates advance.
• By
Strong sales growth for the German group’s SGLT2 inhibitor in 2024
• By
The study’s failure in the overall MDD population was not a surprise, but solriamfetol’s efficacy in MDD with EDS provided a rationale for testing it in that subpopulation.