A drug receives FDA approval for the first time to reduce chemotherapy-induced bone marrow suppression

On 12 February 2021, the United States Food and Drug Administration (FDA), approved trilaciclib under the brand name Cosela, for patients with advanced small-cell lung cancer as the first treatment in its class to reduce the frequency of chemotherapy-induced bone marrow suppression. Trilaciclib (Cosela) may help protect bone marrow cells from damage caused by chemotherapy by inhibiting cyclin-dependent kinase (CDK) 4/6, a type of enzyme.

For patients with advanced small-cell lung cancer, preserving bone marrow function may help make their chemotherapy safer and help them complete treatment on time and according to plan. Trilaciclib's approval will offer patients a treatment option that may reduce the occurrence of a common, harmful side effect of chemotherapy.

Chemotherapy drugs are designed to kill cancer cells, but they may also damage normal tissues. Bone marrow is particularly sensitive to chemotherapy damage. Bone marrow produces red blood cells, white blood cells and platelets (small blood platelets), which carry oxygen, fight infection and stop bleeding. When bone marrow function is suppressed, it produces fewer of these cells, which leads, among other problems, to fatigue, an increased risk of infection and bleeding. Cosela may help protect normal bone marrow cells from the harmful effects of chemotherapy.

• Related topic: The most commonly preferred chemotherapy regimen in small-cell lung cancer: Sisplatin plus Etoposid 

The efficacy of Cosela in patients with advanced small-cell lung cancer was evaluated in three randomized, double-blind, placebo-controlled clinical trials. Combined, these studies randomly assigned 245 patients to receive an intravenous infusion of Cosela 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 count of white blood cells called neutrophils) and the duration of severe neutropenia in the first cycle of chemotherapy. In all three studies, patients who received Cosela had a lower chance of experiencing severe neutropenia than those who received a placebo. Among those with severe neutropenia, patients who received Cosela had, on average, a shorter duration of neutropenia than patients who received a placebo. 

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