Agenus Reports the Withdrawal of BLA for Balstilimab to Treat Cervical Cancer
Shots:
- The company has reported the voluntary withdraw of balstilimab’s BLA in patients with cervical cancer- following the US FDA’s recommendation & the decision follows the full approval of pembrolizumab
- The company will discontinue its ongoing BRAVA trial evaluating Balstilimab & plans to launch expanded access programs to provide patient access to balstilimab in multiple countries- including the US
- The therapy has received FTD & PR designation from the US FDA with a PDUFA date is Dec 16- 2021. The company will continue to accelerate the development of AGEN1181 + balstilimab to support full or accelerated approval in multiple tumor types
| Ref: Agenus | Image: Agenus
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