FDA Grants Fast Track Designation for Balstilimab to Treat Advanced Cervical Cancer

Agenus received approval from the FDA for fast track designation of balstilimab monotherapy and balstilimab and zalifrelimab combination therapy for the treatment of metastatic cervical cancer.

The FDA granted Agenus fast track designation to investigate balstilimab monotherapy as well as balstilimab and zalifrelimab as a combination therapy for the treatment of advanced cervical cancer, according to a recent Agenus press release.1

Agenus, an immune-oncology organization with a number of agents that activate immune responses to cancers, also expects to file 2 biologic licensing applications this year for the balstilimab and zalifrelimab combination, as well as balstilimab monotherapy as treatment for metastatic cervical cancer.

"We are pleased to have now been granted Fast Track designation by FDA for both balstilimab as a monotherapy and in combination with zalifrelimab (anti-CTLA-4) in recognition of the high unmet medical need in second line cervical cancer," Dr. Anna Wijatyk, head of clinical development at Agenus, said in a 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."

A pre-planned, interim analysis revealed robust data balstilimab and zalifrelimab as treatment for relapsed or refractory metastatic cervical cancer. The objective response rate was 26.5% for the combination therapy, while the objective response rate for balstilimab monotherapy was 14.3%. The data was collected in an all-comer, non-biomarker population of patients with refractory cervical cancer who failed prior platinum chemotherapy.

The FDA grants fast track designation with the intention for the treatment of “serious or life-threatening disease or conditions, which demonstrate the potential to address an unmet medical need.” This allow the opportunity for the organization to discuss with the FDA development plans for the drug as well as ensuring the correct data will be collected for drug approval.

According to the World Health Organization, cervical cancer is the fourth most common type of cancer in women.Approximately 570,000 new cases appeared in 2018 worldwide, which represented 6.6% of all cancers among women.

Agenus, Inc. is a clinical-stage immune-oncology company based in Lexington, Massachusetts focused on the “the discovery and development of therapies that engage the body's immune system to fight cancer.”


1. Agenus Receives Fast Track Designation for Balstilimab in Advanced Cervical Cancer [news release]. Lexington, Massachusetts. Published April 7, 2020. https://investor.agenusbio.com/2020-04-07-Agenus-Receives-Fast-Track-Designation-for-Balstilimab-in-Advanced-Cervical-Cancer. Accessed April 8, 2020.

2. World Health Organization. Cervical Cancer. WHO website. https://www.who.int/cancer/prevention/diagnosis-screening/cervical-cancer/en/. Accessed April 8, 2020.