On February 12, 2021, the U.S. Food and Drug Administration (FDA) approved trilaciclib (Cosela™) as the first therapy in its class to reduce the frequency of chemotherapy-induced myelosuppression in adults receiving certain types of chemotherapy for extensive-stage small cell lung cancer. Trilaciclib inhibits cyclin-dependent kinase 4/6 (CDK 4/6) enzymes to prevent bone marrow damage.   

FDA Approves Trilaciclib to Reduce Chemotherapy-Induced Myelosuppression

Effectiveness was evaluated in three randomized, double-blind, placebo-controlled studies of 245 total patients with extensive-stage small cell lung cancer who were randomly assigned to receive either trilaciclib via IV infusion or placebo prior to chemotherapy. In all three studies, patients who received trilaciclib had a lower risk of severe neutropenia or experienced it for a shorter duration than patients who received the placebo.  

The most common adverse reactions (≥ 10%) were fatigue, hypocalcemia, hypokalemia, hypophosphatemia, increased aspartate aminotransferase, headache, and pneumonia. Serious adverse reactions occurred in 30% of patients receiving trilaciclib, included respiratory failure, hemorrhage, and thrombosis. Grade 3/4 hematologic adverse reactions occurring in patients treated with trilaciclib and placebo included neutropenia (32% and 69%), febrile neutropenia (3% and 9%), anemia (16% and 34%), thrombocytopenia (18% and 33%), and leukopenia (4% and 17%), respectively. Patients should also be advised about injection site reactions, acute drug hypersensitivity, interstitial lung disease or pneumonitis, and embryo-fetal toxicity.   

Trilaciclib is administered via IV as a 30-minute infusion within four hours prior to the start of chemotherapy. 

View full prescribing information for trilaciclib.  

FDA granted the application priority review and breakthrough therapy designations. A description of FDA expedited programs is in the Guidance for Industry—Expedited Programs for Serious Conditions—Drugs and Biologics.  

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 800-FDA-1088.    

For assistance with single-patient oncology investigational new drug applications, contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov.