FDA Grants Accelerated Approval to Sacituzumab Govitecan for Advanced Urothelial Cancer

On 13 April 2021, the US Food and Drug Administration (FDA) granted accelerated approval to sacituzumab govitecan (Trodelvy, Immunomedics Inc.) for patients with locally advanced or metastatic urothelial cancer (mUC) who previously received a platinum-containing chemotherapy and either a programmed death receptor-1 (PD-1) or a programmed death-ligand 1 (PD-L1) inhibitor.

Efficacy and safety were evaluated in TROPHY (IMMU-132-06; NCT03547973), a single-arm, multicentre study that enrolled 112 patients with locally advanced or mUC who received prior treatment with a platinum-containing chemotherapy and either a PD-1 or PD-L1 inhibitor. Patients received sacituzumab govitecan, 10 mg/kg intravenously, on days 1 and 8 of a 21-day treatment cycle.

The main efficacy endpoints were objective response rate (ORR) and duration of response (DoR), evaluated by independent review using RECIST v1.1 criteria.

The confirmed ORR was 27.7% (95% confidence interval [CI] 19.6, 36.9) with 5.4% complete responses and 22.3% partial responses. The median DoR was 7.2 months (n=31; 95% CI 4.7, 8.6; range 1.4+, 13.7).

Most common adverse reactions (incidence >25%) in patients receiving sacituzumab govitecan are neutropenia, nausea, diarrhoea, fatigue, alopecia, anaemia, vomiting, constipation, decreased appetite, rash, and abdominal pain.

The recommended sacituzumab govitecan dose is 10 mg/kg once weekly on days 1 and 8 of 21-day treatment cycles until disease progression or unacceptable toxicity.

Full prescribing information for Trodelvy is available here.

This indication is approved under accelerated approval based on tumour 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.

This review used the Real-Time Oncology Review pilot programme, which streamlined data submission prior to the filing of the entire clinical application, and the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment. The FDA approved this application 6 weeks ahead of the FDA goal date.

This application was granted priority review and fast track designation.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System.

For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact FDA’s Oncology Center of Excellence Project Facilitate.

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