G1 Therapeutics announced the availability of Cosela™ (trilaciclib) to decrease the incidence of chemotherapy-induced myelosuppression in adults when administered prior to a platinum- or etoposide-containing chemotherapy regimen or a topotecan-containing regimen for the treatment of extensive-stage small cell lung cancer (ES-SCLC).
The approval was based on data from 3 randomized, placebo-controlled trials (ClinicalTrials.gov: NCT02499770, NCT03041311, NCT02514447), which included 245 adults with ES-SCLC who received an intravenous infusion of Cosela or placebo prior to chemotherapy. Findings from these studies showed that treatment with Cosela resulted in clinically meaningful and statistically significant reductions in the duration and severity of neutropenia. Moreover, Cosela was associated with a lower risk of severe neutropenia and a shorter duration of neutropenia compared with placebo.
The most common adverse reactions reported with Cosela were fatigue, hypocalcemia, hypokalemia, hypophosphatemia, increased aspartate aminotransferase, headache, and pneumonia. Other potential risks associated with the use of Cosela include injection site reactions, acute drug hypersensitivity, interstitial lung disease/pneumonitis, and embryo-fetal toxicity.
Cosela is available through specialty distributors as a single-dose vial containing 300mg of trilaciclib as a lyophilized cake. Following reconstitution and further dilution, Cosela is administered as a 30-minute intravenous infusion completed within 4 hours prior to the start of chemotherapy on each day chemotherapy is administered.
G1 Therapeutics is offering a patient support program called G1 to One™ that provides financial assistance to eligible patients, payer-specific guidance for prior authorizations, and solutions for insurance-related delays.
For more information visit cosela.com.
1. G1 Therapeutics and Boehringer Ingelheim announce commercial availability of Cosela™ (trilaciclib), the only FDA-approved multilineage myeloprotection therapy to decrease the incidence of chemotherapy-induced myelosuppression. [press release]. Research Triangle Park, NC: G1 Therapeutics; March 2, 2021.
2. Cosela [package insert]. Durham, NC: G1 Therapeutics, Inc.; 2021.