The FDA approved Cosela, a first-in-its-class therapy 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 U.S. Food and Drug Administration (FDA) on Friday approved Cosela (trilaciclib), a first-in-its-class therapy to reduce the frequency of chemotherapy-induced bone marrow suppression in adults who are receiving certain types of chemotherapy for extensive-stage small cell lung cancer that has spread beyond the lungs.
“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 Dr. Albert Deisseroth, supervisory medical officer in the Division of Non-Malignant Hematology in the FDA’s Center for Drug Evaluation and Research, in an agency-issued press release on the approval. “Today’s approval of Cosela will give patients a treatment option that can reduce the occurrence of a common, harmful side effect of chemotherapy.”
According to the release, Cosela may help protect bone marrow cells from chemotherapy damage by inhibiting cyclin-dependent kinase 4/6, a type of enzyme. These cells are especially susceptible to damage from chemotherapy, and when damaged, could lead to the production of fewer red blood cells, white blood cells, and platelets. This could, in turn, increase a patient’s risk of infection and bleeding, and could also cause fatigue.
The approval is based on the results of three randomized, double-blind, placebo-controlled studies in patients with extensive-stage small cell lung cancer, which enrolled a total of 245 patients to receive either an infusion of Cosela or a placebo before chemotherapy. Researchers then compared the number of patients who experienced severe neutropenia (a very low white blood cell, or neutrophil, count) in the first cycle of chemotherapy, and also examined how long the neutropenia lasted.
Patients who received Cosela had a lower risk of severe neutropenia compared to placebo in all three trials, and those who had severe neutropenia and received Cosela, had it for a shorter amount of time than those who received a placebo.
The most common side effects of Cosela include fatigue; low calcium, potassium and phosphate levels; increased levels of an enzyme called aspartate aminotransferase; headache; and infection in the lungs (pneumonia). Other things patients should be aware of include injection site reactions, acute drug hypersensitivity, interstitial lung disease/pneumonitis (lung tissue inflammation) and embryo-fetal toxicity.
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