Trodelvy

Trodelvy (sacituzumab govitecan) is a drug indicated for the treatment of adult patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease. The application for this indication was submitted as a Biologics License Application (BLA) on November 30, 2019, and received Priority status, leading to an Accelerated Approval recommendation with a PDUFA Goal Date of June 2, 2020.

In efficacy studies, Trodelvy demonstrated an investigator-assessed clinical benefit rate (CBR) of 44.4% and 45.4%, with a median progression-free survival (PFS) of 5.5 to 5.6 months. The median overall survival time was 13.0 months, and the confirmed objective response rate (ORR) was 33.3%. For comparison, Eribulin showed an observed response rate of 11% and a median duration of response of 4.2 months, with a hazard ratio for overall survival of 0.81 (95% CI: 0.66, 0.99). Ixabepilone had an investigator-assessed ORR of 18.3% (95% CI: 11.9, 26.1) and a central, independently-assessed ORR of 12.4% (95% CI: 6.9, 19.9), with a median duration of response of 6.0 months by central assessment.

Regarding safety, 70.3% of patients experienced Grade 3-4 adverse events. The median duration of treatment for the mTNBC population was 5.1 months. Dose reductions occurred in 34.3% of patients in the mTNBC population. A Grade 3-4 upper respiratory tract infection was observed in 0.9% of the efficacy population.