On February 12, the U.S. Food and Drug Administration (FDA) approved trilaciclib (Cosela) as the first therapy in its class to reduce the frequency of chemotherapy-induced bone marrow suppression in adults receiving certain types of chemotherapy for extensive-stage small cell lung cancer (SCLC). Trilaciclib may help protect bone marrow cells from damage caused by chemotherapy by inhibiting cyclin-dependent kinase 4/6.
“For patients with extensive-stage 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. “[The] approval of trilaciclib will give patients a treatment option that can reduce the occurrence of a common, harmful side effect of chemotherapy.”
The bone marrow is particularly susceptible to chemotherapy damage. The bone marrow makes red blood cells, white blood cells, and platelets that transport oxygen, fight infection, and stop bleeding; when damaged, the bone marrow produces fewer of these cells, leading to fatigue, increased risk of infection, and bleeding, among other problems. Trilaciclib may help protect the normal bone marrow cells from the harmful effects of chemotherapy.
The effectiveness of trilaciclib was evaluated in three randomized, double-blind, placebo-controlled studies in patients with extensive-stage SCLC. Combined, these studies randomly assigned 245 patients to receive either an intravenous infusion of trilaciclib or a placebo before chemotherapy. The studies then compared the two groups for the proportion of patients with severe neutropenia and the duration of severe neutropenia in the first cycle of chemotherapy. In all three studies, patients who received trilaciclib had a lower chance of having severe neutropenia compared to patients who received a placebo. Among those who had severe neutropenia, patients who received trilaciclib, on average, had it for a shorter time than patients who received a placebo.
The most common side effects of trilaciclib include fatigue; low levels of calcium, potassium, and phosphate; increased levels of aspartate aminotransferase; headache; and pneumonia. Patients should also be advised about injection site reactions, acute drug hypersensitivity, interstitial lung disease/pneumonitis, and embryo-fetal toxicity.