Trodelvy Receives Accelerated Approval for Urothelial Cancer

April 13, 2021 – The U.S. FDA has given accelerated approval to Trodelvy® (sacituzumab govitecan- hziy), manufactured by Gilead, for a new indication to treat locally advanced or metastatic urothelial cancer (UC) in adults who have previously received a platinum-containing chemotherapy and a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor. Continued approval for the indication is contingent upon verification and description of clinical benefit in a confirmatory trial.

UC is the most common form of bladder cancer, expected to account for almost 90% of U.S. bladder cancer diagnoses in 2021. It begins in the cells that line the bladder and other parts of the urinary tract, and often recurs even when treatment has been successful. The prognosis for patients with metastatic UC – which occurs when the cancer spreads to other parts of the body – is poor, with a five-year survival rate of 5.5%.

In a clinical study, Trodelvy delivered an objective response rate of 27.7%, with a 7.2-month median duration of response. Of the study participants evaluated, 5.4% had a complete response to Trodelvy, while 22.3% experienced a partial response.

Recommended dosing is 10mg/kg of the patient’s body weight administered via intravenous infusion on Days 1 and 8 of 21-day treatment cycles until disease progression or unacceptable toxicity occur. The first infusion should take place over the course of three hours. If tolerated, subsequent infusion times can be reduced to 1-2 hours. Patients should be observed for infusion reactions for at least 30 minutes after every infusion.

A black box warning cautions that Trodelvy can cause severe diarrhea and severe or life-threatening neutropenia (abnormally low level of neutrophils, a type of white blood cell), which can increase the risk of infection.