FDA grants priority review to trilaciclib for small cell lung cancer
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The FDA granted priority review to trilaciclib for treatment of patients with small cell lung cancer who are receiving chemotherapy, according to the agent’s manufacturer.
Trilaciclib (G1 Therapeutics/Boehringer Ingelheim) is a cyclin dependent kinase 4/6 inhibitor designed to preserve bone marrow and immune system function during chemotherapy.
“While undergoing chemotherapy, many patients experience significant myelosuppression, become fatigued and susceptible to infection, and often require transfusions and growth factor administrations,” Jared Weiss, MD, associate professor at Lineberger Comprehensive Cancer Center at The University of North Carolina at Chapel Hill, said in a G1 Therapeutics-issued press 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 FDA based the priority review on results of three randomized, double-blind, placebo-controlled clinical trials that included patients with small cell lung cancer.
Results showed the addition of trilaciclib to chemotherapy significantly reduced chemotherapy-induced myelosuppression. Trilaciclib-treated patients experienced fewer dose delays or reductions, infections and hospitalizations, and they also required fewer rescue therapies.
The FDA — which previously granted breakthrough therapy designation to trilaciclib for this indication — is expected to make a decision on approval by Feb. 15.
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