Agenus Inc (NASDAQ: AGEN) is pleased to announce the U.S. Food and Drug Administration (FDA)’s stand concerning its License Application. The company sent an application to the body to review Biologics License Application (BLA) for balstilimab.
Company’s efforts to treat severe conditions
The company developed the anti-PD-1 antibody to aid in the treatment of metastatic or recurrent cervical cancer. The company believes that the product is effective after chemotherapy and in the course of the disease progression.
Agenus Inc likes how matters are unfolding so far, outlining that the body has granted its Priority Review to the company’s recent submission.
Technological advancements and innovations continue presenting many working solutions and therapies to pepsins struggling with different conditions. Therefore, the company seeks to remain at the frontline in providing the most outstanding solutions to persons suffering from various diseases by turning to its extensive pipeline of agents.
The immuno-oncology company is known for its adjuvants, cell therapies, antibodies, and vaccines geared towards activating strong immune responses to infections and cancers. It applauds the FDA’s move, outlining that it is a significant contribution to its manufacturing activities meant to help the masses deal with the most adverse medical conditions.
What an approval could mean
Agenus Inc’s designation for drugs is pending approval, but matters might turn out different soon. According to analysts, approval could significantly boost the treatment’s effectiveness and safety in some diverse conditions.
The FDA turns to the Prescription Drug User Fee Act (PDUFA) in setting up a target action date. Reports indicate the projected date to be around December 16, 2021.
Cervical cancer is a dangerous condition that affects more women across the United States and the world. This year alone, experts project the diagnosis of about 14,000 women with invasive cervical cancer in the U.S. Another report indicates that about 4,000 women might end up losing their lives because of the severe condition. Cervical cancer remains a significant cause of death among women in the U.S.