Basic benefit and medical policy
Trodelvy (sacituzumab govitecan-hziy)
Effective April 7, 2021, Trodelvy (sacituzumab govitecan-hziy) is covered for the following updated FDA-approved indications:
Trodelvy is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer, known as mTNBC, who have received two or more prior systemic therapies, at least one of them for metastatic disease.
Patients with locally advanced or metastatic urothelial cancer, or mUC, who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PDL1) inhibitor
This indication is approved under accelerated approval, based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Dosage and administration:
The recommended dose for Trodelvy is 10 mg/kg once weekly on days 1 and 8 of continuous 21-day treatment cycles until disease progression or unacceptable toxicity.
Dosage forms and strengths:
For injection: 180 mg lyophilized powder in single-dose vials for reconstitution.
This change isn’t a benefit for URMBT. |