FDA grants fast track designation to sacituzumab govitecan for urothelial cancer subset
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The FDA granted fast track designation to sacituzumab govitecan for treatment of certain adults with locally advanced or metastatic urothelial cancer.
The designation applies to use of the agent for patients who previously received a PD-1 or PD-L1 inhibitor and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting.
Sacituzumab govitecan (IMMU-132, Immunomedics) — an antibody-drug conjugate — combines an antibody to the Trop-2 antigen and releases SN-38, the metabolite of the chemotherapy drug irinotecan, directly into cancer cells and into the tumor microenvironment.
The phase 2 TROPHY U-01 study is evaluating the agent for 100 patients with metastatic urothelial carcinoma. Interim results showed a 29% overall response rate among 35 cisplatin-eligible patients who relapsed after or were refractory to PD-1 or PD-L1 inhibitors and platinum-based chemotherapy. Topline data from the full cohort are expected in the second half of the year.
“Coming in the wake of a recent unanimous recommendation by the independent Data Safety Monitoring Committee for the ASCENT study to stop the trial due to compelling evidence of efficacy in metastatic triple-negative breast cancer, it is gratifying to learn of the FDA’s recognition of sacituzumab govitecan’s potential in urothelial cancer, an important second indication for our lead antibody-drug conjugate,” Loretta M. Itri, MD, chief medical officer at Immunomedics, said in a company-issued press release. “With the upcoming maturation of the data from the 100-patient cohort with prior platinum-based and PD-1 or PD-L1 inhibitor therapies, and based on the fast track designation, we will actively seek guidance from the FDA on a potential accelerated approval pathway.”