FDA approves drug to reduce bone marrow suppression caused by chemotherapy

FDA has approved trilaciclib (Cosela—G1 Therapeutics) as the first therapy in its class to reduce the frequency of chemotherapy-induced bone marrow suppression in adults receiving certain types of chemo for extensive-stage small cell lung cancer. According to FDA, the drug may help protect bone marrow cells from chemotherapy-related damage by inhibiting cyclin-dependent kinase 4/6. “For patients with extensive-stage small cell lung cancer, 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 FDA’s Center for Drug Evaluation and Research. “Today’s approval of Cosela will give patients a treatment option that can reduce the occurrence of a common, harmful side effect of chemotherapy.” The effectiveness of trilaciclib was assessed in three randomized, double-blind, placebo-controlled studies in patients with extensive-stage small cell lung cancer. The most common adverse effects from the drug include fatigue; low levels of calcium, potassium and phosphate; increased levels of aspartate aminotransferase; headache; and pneumonia. However, patients should also be advised about injection site reactions, acute drug hypersensitivity, interstitial lung disease/pneumonitis, and embryo-fetal toxicity.