The FDA granted fast track designation for investigation of balstilimab in combination with zalifrelimab for the treatment of patients with relapsed or refractory metastatic cervical cancer, according to Agenus, the agent’s developer.1
The designation was based on comprehensive data that supported the potential for balstilimab and zalifrelimab.
“We are pleased that balstilimab and zalifrelimab have been granted fast track designation by FDA in recognition of the high unmet medical need in second line cervical cancer,” said Jennifer Buell, PhD, president and COO of Agenus, said in a press release. “We are excited about the prospect of making these novel agents available to women who suffer from metastatic cervical cancer. We look forward to continuing to work with FDA as we advance new treatment options for patients with cancer.”
Following this regulatory action, the…