publication date: Feb. 19, 2021

Drugs & Targets

FDA approves Cosela to reduce bone marrow suppression caused by chemotherapy

FDA has approved Cosela (trilaciclib) 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.

Cosela is sponsored by G1 Therapeutics inc.

Cosela may help protect bone marrow cells from damage caused by chemotherapy by inhibiting cyclin- dependent kinase 4/6, a type of enzyme.

“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, supervisory medical officer in the Division of Non-Malignant Hematology in the FDA’s Center for Drug Evaluation and Research, said in a 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.”

When damaged, the bone marrow produces fewer of these cells, leading to fatigue, increased risk of infection, and bleeding, among other problems. Cosela may help protect the normal bone marrow cells from the harmful effects of chemotherapy.

The effectiveness of Cosela was evaluated in 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 Cosela in their veins 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 Cosela had a lower chance … Continue reading FDA approves Cosela to reduce bone marrow suppression caused by chemotherapy

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