FDA Brief: Trilaciclib Plus Chemotherapy Granted Fast Track Designation in Triple-Negative Breast Cancer
Posted: Monday, July 26, 2021
The U.S. Food and Drug Administration (FDA) recently granted Fast Track designation to the CDK4/6 inhibitor trilaciclib in combination with chemotherapy for the treatment of locally advanced or metastatic triple-negative breast cancer.
Trilaciclib is currently being evaluated in PRESERVE 2, a phase III, randomized, double-blind, placebo-controlled study (ClinicalTrials.gov identifier NCT04799249) in patients receiving first- or second-line gemcitabine and carboplatin chemotherapy for triple-negative breast cancer. This trial intends to enroll about 250 patients, who will be randomly assigned to receive gemcitabine (1,000 mg/m2) and carboplatin (AUC 2) as well as trilaciclib (240 mg/m2) or placebo. The primary endpoint of the trial is overall survival, and quality of life, myeloproliferative effects, and progression-free survival are secondary endpoints.