April 08, 2020
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FDA grants fast track status to balstilimab for advanced cervical cancer

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The FDA granted fast track designation to balstilimab for treatment of women with advanced cervical cancer.

Balstilimab (Agenus) is an anti-PD-1 therapy.

Agenus expects to file two biologics license applications with the FDA this year seeking accelerated approval of balstilimab monotherapy, as well as the combination of balstilimab and the anti-CTLA-4 therapy zalifrelimab (Agenus), for treatment of metastatic cervical cancer.

As Healio previously reported, the FDA granted fast track designation to the combination last month.

One study evaluated both treatment approaches for an all-comers, nonbiomarker-selected population of women with refractory cervical cancer who failed prior platinum chemotherapy with or without bevacizumab (Avastin, Genentech).

Updated data from a preplanned analysis of study showed a 26.5% objective response rate with the balstilimab-zalifrelimab combination and a 14.3% ORR for balstilimab monotherapy.

“We are pleased to have now been granted fast track designation by FDA for both balstilimab as a monotherapy and in combination with zalifrelimab in recognition of the high unmet medical need in second-line cervical cancer,” Anna Wijatyk, MD, head of clinical development at Agenus, said in a company-issued press release. “The fast track designation confers important benefits, including the potential eligibility for a priority review, and we are excited to work with the FDA to quickly advance novel agents for women who suffer from metastatic cervical cancer."