FDA approves trilaciclib for bone marrow damage caused by chemotherapy
The FDA approved a therapy to reduce the frequency of chemotherapy-related bone marrow suppression in adults with extensive-stage small cell lung cancer.
The agency stated in a release that it approved trilaciclib (Cosela, G1 Therapeutics) for the protection of bone marrow cells from damage caused by chemotherapy by inhibiting the enzyme cyclin-dependent kinase 4/6.
According to the release, trilaciclib was evaluated in three randomized, double-masked, placebo-controlled studies in patients with extensive-stage small cell lung cancer, all of which showed patients assigned trilaciclib had decreased risk for severe neutropenia compared with patients assigned placebo.
“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,” Albert Deisseroth, MD, PhD, supervisory medical officer in the FDA’s Division of Non-Malignant Hematology, said in the statement. “Today’s approval of Cosela will give patients a treatment option that can reduce the occurrence of a common, harmful side effect of chemotherapy.”
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