Gilead’s antibody drug conjugate (ADC) Trodelvy has received an accelerated approval from the US Food and Drug Administration (FDA) for the treatment of locally advanced or metastatic urothelial cancer (UC), the most common form of bladder cancer.
The approval covers the use of Trodelvy (sacituzumab govitecan-hziy) in patients with advanced UC who have previously received a platinum-containing chemotherapy and either a PD-1 or PD-L1 inhibitor.
Trodelvy was approved on the basis of results from Gilead’s Phase II TROPHY study, which evaluated the drug as monotherapy or as a combination therapy in patients with metastatic UC after progression on a platinum-based chemotherapy and PD-1/L1 inhibitor.
In 112 patients who were evaluable for efficacy, 27.7% of those who were treated with Trodelvy responded to treatment, with 5.4% experiencing a complete response and 22.3% experiencing a partial response.
The study also found a median duration of response of 7.2 months for those treated with Gilead’s drug.
Trodelvy has been approved with a boxed warning for severe or life-threatening neutropenia and severe diarrhoea, Gilead added in a statement.
“Today’s accelerated approval is thanks to the patients and healthcare professionals involved in the TROPHY study, and we appreciate their partnership,” said Merdad Parsey, chief medical officer, Gilead Sciences.
“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,” he added.
Trodelvy was initially granted accelerated approval by the FDA in April 2020 for the treatment of adults with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease.
Gilead picked up the ADC as part of its $21bn acquisition of Immunomedics, announced last year.