Agenus Reports the Withdrawal of BLA for Balstilimab to Treat Cervical Cancer

October 25, 2021 Auto Bot Agenus, BLA, cervical cancer, Clinical Trials 0

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

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