Trilaciclib Approved for Chemotherapy-Induced Myelosuppression

The U.S. Food and Drug Administration (FDA) has approved trilaciclib, a cyclin-dependent kinase 4/6 inhibitor, to reduce the frequency of bone marrow suppression in adult patients with extensive-stage small cell lung cancer (ES-SCLC) who are receiving certain types of chemotherapy.

This decision was based on results from three studies enrolling 245 patients with ES-SCLC who were randomized to receive either intravenous trilaciclib or placebo prior to starting chemotherapy. In all three studies, patients in the trilaciclib group had a lower risk of severe neutropenia compared with patients receiving placebo. Additionally, duration of severe neutropenia was shorter in patients who received trilaciclib compared to placebo.

“For patients with ES-SCLC, protecting bone marrow function may help make their chemotherapy safer and allow them to complete their course of treatment on time and according to plan,” said Albert Deisseroth, MD, PhD, supervisory medical officer in the Division of Non-Malignant Hematology in the FDA’s Center for Drug Evaluation and Research. “Today’s approval will give patients a treatment option that can reduce the occurrence of a common, harmful side effect of chemotherapy.”

The most common adverse events (AEs) include fatigue, hypocalcemia, hypokalemia, hypophosphatemia, increased levels of aspartate aminotransferase, headache, and pneumonia. The FDA recommends advising patients about injection site reactions, acute drug hypersensitivity, interstitial lung disease/pneumonitis, and embryo-fetal toxicity.

Sources: FDA.gov, February 12, 2021; ClinicalTrials.gov: NCT02499770, NCT03041311, and NCT02514447.