Dr. Weiss on the FDA Approval of Trilaciclib in Small Cell Lung Cancer

Jared Weiss, MD, associate professor of medicine, Division of Oncology, Department of Medicine, University of North Carolina (UNC) School of Medicine, associate director of finance, UNC Lineberger Clinical Protocol Office, UNC Lineberger Comprehensive Cancer Center, discusses the FDA approval of trilaciclib (Cosela) in small cell lung cancer (SCLC).

On February 12, 2021, the FDA approved trilaciclib to reduce the frequency of chemotherapy-induced bone marrow suppression in adults receiving certain types of chemotherapy for extensive-stage SCLC.

The regulatory decision was based on myelopreservation data from 3 randomized, double-blind, placebo-controlled clinical trials where the first-in-class investigational therapy was given prior to chemotherapy in patients with SCLC. In a pooled analysis of the studies, the administration of the CDK4/6 inhibitor prior to chemotherapy resulted in a significant decrease in most measures of multilineage chemotherapy-induced myelosuppression, as well as the need for supportive care interventions.

Overall survival and progression-free survival did not appear to be affected by the addition of trilaciclib, which was consistent with the hypotheses that were generated based on the agent’s mechanism of action, Weiss explains. Instead, trilaciclib can offer patients with SCLC improvement in chemotherapy-induced toxicities and quality of life, concludes Weiss.