- For immediate release:
The U.S. Food and Drug Administration has approved Cosela (trilaciclib) as the first therapy in its class to reduce the frequency of chemotherapy-induced bone marrow suppression in adults who have received certain types of chemotherapy at an extended stage (when the cancer has spread beyond the lungs) small cell lung cancer. Cosela can help protect bone marrow cells from damage caused by chemotherapy by inhibiting cyclin-dependent kinase 4/6, a type of enzyme.
“For patients with an extensive stage of small cell lung cancer, the protection of bone marrow function can help make their chemotherapy safer and enable them to complete their treatment on time and on schedule,” said Albert Deisseroth, MD, MD . supervisory officer in the Division of Non-Malignant Hematology at the FDA’s Center for Drug Evaluation and Research. “Today’s approval of Cosela will give patients a treatment option that can reduce the incidence of a common, harmful side effect of chemotherapy.”
Chemotherapy drugs are designed to kill cancer cells, but can also damage normal tissues. The bone marrow is particularly susceptible to chemotherapy damage. The bone marrow makes red blood cells, white blood cells and platelets (small fragments in the blood) that carry oxygen, fight infection and stop bleeding. If damaged, the bone marrow produces less of these cells, which leads to fatigue, increased risk of infection and bleeding, among other things. Cosela can help protect the normal bone marrow cells from the harmful effects of chemotherapy.
The efficacy of Cosela has been evaluated in three randomized, double-blind, placebo-controlled studies in patients with advanced small cell lung cancer. These studies randomly assigned 245 patients to receive an infusion of Cosela in their veins or a placebo before chemotherapy. The studies compared the two groups for the proportion of patients with severe neutropenia (a very low amount of white blood cells called neutrophils) and the duration of severe neutropenia in the first cycle of chemotherapy. In all three studies, patients receiving Cosela had a lower chance of having severe neutropenia compared with patients receiving placebo. Among those who had severe neutropenia, patients who received Cosela on average had it for a shorter time than patients who received a placebo.
The most common side effects of Cosela include fatigue; low levels of calcium, potassium and phosphate; elevated levels of an enzyme called aspartate aminotransferase; headache; and infection in the lungs (pneumonia).
Patients should also be informed about injection site reactions, acute drug hypersensitivity, interstitial pneumonia / pneumonia (pneumonia) and embryo-fetal toxicity.
Cosela receives the FDA Priority Review and Breakthrough Therapy designations for the above indication.
The FDA has approved Cosela’s approval for G1 Therapeutics, Inc.
The FDA, an agency within the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of human and veterinary drugs, vaccines, and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of food supply, cosmetics, nutritional supplements, products that emit electronic radiation and for the regulation of tobacco products in our country.
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