WASHINGTON—The FDA approved tilaciclib (Cosela) to reduce chemotherapy-induced bone marrow suppression in adults. Tilaciclib, which protects bone marrow cells by inhibiting cyclin-dependent kinase 4/6, is the first drug to win FDA approval for this indication.
In a prepared statement from the FDA, Albert Deisseroth, MD, PhD, supervisory medical officer in the Division of Non-Malignant Hematology in the FDA’s Center for Drug Evaluation and Research, said, “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. Today’s approval of [tilaciclib] will give patients a treatment option that can reduce the occurrence of a common, harmful side effect of chemotherapy.”
The approval was based on findings from three randomized, double-blind, placebo-controlled studies in patients with extensive-stage small cell lung cancer. “Combined, these studies randomly assigned 245 patients to receive either an infusion of tilaciclib in their veins or a placebo before chemotherapy. The studies then compared the two groups for the proportion of patients with severe neutropenia (a very low count of white blood cells called neutrophils) and the duration of severe neutropenia in the first cycle of chemotherapy. In all three studies, patients who received tilaciclib had a lower chance of having severe neutropenia compared to patients who received a placebo. Among those who had severe neutropenia, patients who received tilaciclib, on average, had it for a shorter time than patients who received a placebo.”
The most common toxicities observed were fatigue, low levels of calcium, potassium and phosphate; increased levels of aspartate aminotransferase, headache, and infection in the lungs (pneumonia). Additionally, patients should be warned about injection site reactions acute drug hypersensitivity, interstitial lung disease/pneumonitis (lung tissue inflammation) and embryo-fetal toxicity.
The FDA granted marketing approval to G1 Therapeutics, Inc., of Research Triangle Park, North Carolina.
Peggy Peck, Editor-in-Chief, BreakingMED™
Cat ID: 116
Topic ID: 78,116,116,118,935,192,151,725,925