FDA grants fast track designation to combination for advanced cervical cancer
Click Here to Manage Email Alerts
The FDA granted fast track designation to balstilimab in combination with zalifrelimab for the treatment of women with relapsed or refractory metastatic cervical cancer, according to the agents’ manufacturer.
Balstilimab (Agenus) is an anti-PD-1 therapy, and zalifrelimab (AGEN1884, Agenus) is an anti-CTLA-4 antibody.
“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,” Jennifer Buell, PhD, president and chief operating officer of Agenus, said in a company-issued press release. “The fast track designation confers important benefits, including the potential eligibility for a priority review. We are excited about the prospect of making these novel agents available to women [with] metastatic cervical cancer.”
The FDA based the fast track designation on data from a preplanned interim analysis of a study that included an all-comer, nonbiomarker-selected population of women with refractory cervical cancer who failed prior platinum chemotherapy with or without bevacizumab (Avastin, Genentech).
Researchers reported a 26.5% objective response rate, with four complete responses and five partial responses. Eight patients had stable disease. Median duration of response had not been reached.
Agenus officials expect to file a biologics license application this year seeking accelerated approval of balstilimab and zalifrelimab for the treatment of metastatic cervical cancer. The company also expects to seek accelerated approval of balstilimab monotherapy for the same indication.