The FDA has approved trilaciclib (Cosela) to reduce the frequency of chemotherapy-induced bone marrow suppression in adults receiving certain types of chemotherapy for extensive-stage small cell lung cancer.
The FDA has approved trilaciclib (Cosela) to reduce the frequency of chemotherapy-induced bone marrow suppression in adults receiving certain types of chemotherapy for extensive-stage small cell lung cancer (ES-SCLC).1
“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,” Albert Deisseroth, MD, PhD, supervisory medical officer in the Division of Non-Malignant Hematology in the FDA’s Center for Drug Evaluation and Research, stated in a press release. “Today’s approval of [trilaciclib] will give patients a treatment option that can reduce the occurrence of a common, harmful side effect of chemotherapy.”
Trilaciclib was evaluated in 3 double-blind, placebo-controlled phase 2 trials in adult patients with ES-SCLC: G1T28-02 (NCT02499770), G1T28-05 (NCT03041311), and G1T28-03 (NCT02514447).2-4 In an analysis presented during the 2020 ASCO Virtual Scientific Program, investigators examined the pooled data from these trials to characterize the myelopreservation effects of the CDK4/6 inhibitor.
G1T28-02 evaluated the clinical benefit of trilaciclib in preserving the bone marrow and the immune system while augmenting the antitumor activity of chemotherapy when given before carboplatin and etoposide in the first-line treatment of patients with newly diagnosed disease. In this trial, patients were administered either trilaciclib or placebo on days 1 through 3 of each 21-day cycle. In G1T28-05, investigators evaluated the potential benefit of the CDK4/6 inhibitor in preserving bone marrow and the immune system while encouraging antitumor efficacy when given with carboplatin, etoposide, and atezolizumab (Tecentriq) in the frontline treatment of patients with newly diagnosed disease.