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 (https://www.g1therapeutics.com/cosela/pi/).  

FDA granted the application priority review (https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-review) and breakthrough therapy (https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy) designations. A description of FDA expedited programs is in the Guidance for Industry—Expedited Programs for Serious Conditions—Drugs and Biologics (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/expedited-programs-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 (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm) or by calling 800-FDA-1088.    

For assistance with single-patient oncology investigational new drug applications, contact OCE’s Project Facilitate (https://www.fda.gov/about-fda/oncology-center-excellence/project-facilitate) at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov (mailto:OncProjectFacilitate@fda.hhs.gov).