The FDA approved trilaciclib (Cosela) Friday to protect bone marrow function and reduce the risk of severe neutropenia caused by chemotherapy in small cell lung cancer (SCLC) patients.
Trilaciclib, a 4/6 cyclin-dependent kinase (CDK) inhibitor, is intended for SCLC patients with widespread disease, prior to chemotherapy. Although several other CDK4 / 6 inhibitors have been approved as treatments for breast cancer, this is the first indication for the class as a myeloprotective agent.
“For patients with advanced small cell lung cancer, bone marrow function protection 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, of the Department of Non – malignant Hematology at the FDA ‘s Drug Assessment and Research Center, said in a statement. “Cosela’s approval today will provide patients with a treatment option that can reduce the common, harmful side effects of chemotherapy.”
Approval was based on results gathered from three randomized, placebo-controlled trials involving 245 patients with extensive SCLC. In the results of the studies presented at the North America Virtual 2020 Conference on Lung Cancer, 11.4% of those receiving trilaciclib before chemotherapy experienced severe neutropenia over the first four treatment cycles versus 52.9% of those specified placebo ((P.<0.0001). The mean duration of major neutropenia was 0 vs. 4 days, respectively.
“Chemotherapy-induced myelosuppression may lead to increased risks of infection, severe anemia, and / or inflammation,” Jeffrey Crawford, MD, of the Duke Cancer Institute in Durham, North Carolina, said in a statement from a manufacturer G1 Therapeutics drugs. “To date, approaches have included the use of growth factor agents to accelerate recovery of blood cells after bone marrow injury has occurred, along with antibiotics and transplants as needed. “
In the collected trial data, granulocyte colon stimulatory factor (G-CSF) for supportive care was less frequently required in patients who received trilaciclib (28.5% vs. 56.3% with placebo), as were erythropoiesis stimulatory agents (3.3% vs. 11.8%).
Common side effects (AEs) with trilaciclib included muscle weakness, headache, hypocalcemia, hypokalemia, hypophosphatemia, increased aspartate aminotransferase, and pneumonia. Severe AEs occur in 30% of patients, with hemorrhage, respiratory failure, and thrombosis being the most common.
In their approval release, the FDA warned of the risk for drug-induced embryo-fetal toxicity, hypersensitivity, injection site reactions, and interstitial lung disease / pneumonitis.