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.
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Sponsors of three drugs have withdrawn their EU marketing authorization applications in the middle of the assessment process, including one for a bladder cancer therapy that was recently turned down in the US.
Keeping Track: Ticovac Is Latest Win For Pfizer’s Vaccine Business; Doors Open For BMS And GSK PD-1 Inhibitors
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
The updated data are in line with prior interim readouts but nonetheless triggered strong reactions. One analyst slashed their peak sales forecast for Vicinium, while another talked up the likelihood of rapid commercial adoption of the fusion protein-drug conjugate.