Gilead Sciences has announced the accelerated approval of Trodelvy (or sacituzumab govitecan-hziy) by the US Food and Drug Administration (FDA) in the treatment of locally advanced or metastatic urothelial cancer (UC) in adult patients.
The accelerated approval also holds good for those patients who were previously treated with a platinum-containing chemotherapy and either a programmed death receptor-1 (PD-1) or a programmed death-ligand 1 (PD-L1) inhibitor.
Data from the international Phase 2, single-arm TROPHY study was considered as the basis for the approval.
The USFDA’s accelerated approval procedure allows drugs treating serious diseases with unmet medical needs to be approved on the basis of a surrogate or intermediate clinical endpoint.
Continued approval of the drug is subject to verification and description of clinical benefit in a confirmatory trial.
Weill Cornell Medicine Medicine and Urology professor, New York-Presbyterian/Weill Cornell Medical Center oncologist and TROPHY study principal investigator, Scott T Tagawa said: “Only a fraction of patients derives long-term benefit from previously approved cytotoxic therapy or immunotherapy, leaving a great unmet need for treatment options for patients with advanced urothelial cancer who have progressed on first- and second-line therapies. The response rate and tolerability seen with sacituzumab govitecan-hziy may provide physicians an effective new treatment option for patients whose cancer continues to progress even after multiple therapies.”
The most common type of bladder cancer, metastatic UC happens when the urothelial cells lining the inside of the bladder and other parts of the urinary tract exhibit uncontrollable growth.
It is estimated that about 83,000 Americans will be diagnosed with bladder cancer in 2021, with nearly 90% of those being UC. Patients with metastatic UC have a relative five-year survival rate of only 5.5%.
Bladder Cancer Advocacy Network (BCAN) CEO Andrea Maddox-Smith said: “Cases of urothelial cancer continue to rise in the US, yet prognosis remains the same for the vast majority of patients. Bladder cancer patients need as many treatment options as possible, and we are pleased that Trodelvy can be a potentially viable treatment for them.”
Gilead Sciences chief medical officer Merdad Parsey said: “Today’s accelerated approval is thanks to the patients and healthcare professionals involved in the TROPHY study, and we appreciate their partnership. This achievement, coupled with last week’s full FDA approval in unresectable locally advanced or metastatic triple-negative breast cancer, underscores our commitment toward rapidly delivering Trodelvy to patients facing some of the most difficult-to-treat cancers.”
A randomised, worldwide Phase 3 confirmatory clinical trial TROPiCS-04 (NCT04527991) is currently ongoing and is also expected to support global registrations.