The Food and Drug Administration granted a priority review to the new drug application for trilaciclib for patients with small cell lung cancer.
The Food and Drug Administration (FDA) granted a priority review designation to trilaciclib for patients with small cell lung cancer (SCLC) who are beginning treatment with chemotherapy, according to G1 Therapeutics, the developer of the agent.
The designation is based on findings from three randomized, double-blind, placebo-controlled trials in which patients with SCLC were administered trilaciclib prior to receiving chemotherapy. The trials demonstrated that trilaciclib significantly reduced chemotherapy-induced myelosuppression and reduced the number of infections and hospitalizations when compared to chemotherapy alone.
“There are currently no available therapies to protect patients from chemotherapy-induced toxicities before they occur,” said Dr. Raj Malik, chief medical officer of G1 Therapeutics, in a company-issued press release. “If approved, trilaciclib would be the first proactively administered myelopreservation therapy that is intended to make chemotherapy safer and reduce the need for rescue interventions, such as growth factor administrations and blood transfusions.”
The investigational therapy, according to the release, is designed to preserve bone marrow and immune system function in patients with SCLC while receiving chemotherapy.
“While undergoing chemotherapy, many patients experience significant myelosuppression, become fatigued and susceptible to infection, and often require transfusions and growth factor administrations,” said Dr. Jared Weiss, of the Lineberger Comprehensive Cancer Center, in the release. “Preventing bone marrow damage proactively is an opportunity to improve the quality of life of patients receiving chemotherapy for small cell lung cancer and reduce costly rescue interventions.”
The agency is set to make its approval decision by February 15, 2021.