In February 2021, the FDA approved Cosela (trilaciclib; from G1 Therapeutics), as the first CDK4/6 inhibitor to reduce the frequency of chemotherapy-induced myelosuppression in adults with extensive-stage small-cell lung cancer, when used before chemotherapy with platinum plus etoposide or a topotecan-containing regimen. Cosela can prevent damage to bone marrow cells by blocking the CDK4/6 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,” said Albert Deisseroth, MD, PhD, Medical Officer 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 occurrence of a common, harmful side effect of chemotherapy.”
The FDA approved Cosela based on data from 3 clinical trials with a total of 245 patients who received either intravenous Cosela or to placebo before chemotherapy. In all 3 studies, patients who received Cosela had a lower risk of serious neutropenia (inability to fight infection) than those who received placebo, and a shorter duration of serious neutropenia.
The most common side effects with Cosela were fatigue, increased levels of aspartate aminotransferase, headache, pneumonia, and deficiencies in calcium, potassium, and phosphate. Serious side effects included neutropenia, thrombocytopenia, anemia, leukopenia, and febrile neutropenia.