FDA approves drug to reduce bone marrow suppression caused by chemotherapy

Today, the US Food and Drug Administration has approved Cosela (trilacyclib) as the first therapy in its class to reduce the frequency of chemotherapy-induced bone marrow suppression in adults receiving certain types of extensive stage chemotherapy (when the cancer has spread beyond lung cancer) small cell lung cancer. Cosela can help protect bone marrow cells from damage caused by chemotherapy by inhibiting kinase 4/6 dependent on cyclin, a type of enzyme.

“For patients with extensive small cell lung cancer, protecting bone marrow function can help make chemotherapy safer and allow them to complete the course of treatment on time and according to the plan,” said Albert Deisseroth, MD, Ph.D., supervising medical officer in the Division of Non-Malignant Hematology at the FDA’s Center for Drug Evaluation and Research. “Cosela’s approval today will give patients a treatment option that can reduce the occurrence of a common and harmful side effect of chemotherapy.”

Chemotherapy drugs are designed to kill cancer cells, but they can also damage normal tissues. Bone marrow is particularly susceptible to damage from chemotherapy. The bone marrow produces red blood cells, white blood cells and platelets (small fragments in the blood) that carry oxygen, fight infections and stop bleeding. When damaged, the bone marrow produces less of these cells, leading to fatigue, increased risk of infection and bleeding, among other problems. Cosela can help protect normal bone marrow cells from the harmful effects of chemotherapy.

The effectiveness of Cosela was assessed in three randomized, double-blind, placebo-controlled studies in patients with extensive small-cell lung cancer. Combined, these studies randomly assigned 245 patients to receive an infusion of Cosela into their veins or a placebo before chemotherapy. The studies then compared the two groups in terms of the proportion of patients with severe neutropenia (a very low white blood cell count called neutrophils) and the duration of severe neutropenia in the first cycle of chemotherapy. In all three studies, patients who received Cosela were less likely to have severe neutropenia compared to patients who received a placebo. Among those who had severe neutropenia, patients who received Cosela, on average, had it for less time than patients who received a placebo.

Cosela’s most common side effects include fatigue; low levels of calcium, potassium and phosphate; increased levels of an enzyme called aspartate aminotransferase; headache; and infection of the lungs (pneumonia).

Patients should also be informed about reactions at the injection site, acute hypersensitivity to the drug, interstitial lung disease / pneumonitis (inflammation of the lung tissue) and embryo-fetal toxicity.

Cosela received priority review assignments and innovative therapy from the FDA for the aforementioned indication.

The FDA granted Cosela approval to G1 Therapeutics, Inc.

The FDA, an agency of the United States 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 security of the supply of food, cosmetics, dietary supplements, products that emit electronic radiation and for the regulation of tobacco products in our country.

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