Gilead Sciences has announced the voluntary withdrawal of the Food and Drug Administration (FDA) approval for Trodelvy (sacituzumab govitecan-hziy) in the treatment of locally advanced or metastatic urothelial cancer, a type of bladder cancer. This decision follows the TROPICS-04 study failing to meet its primary endpoint of overall survival (OS). The withdrawal reduces available treatment options for patients who have previously undergone platinum-containing chemotherapy and a PD-(L)1 inhibitor.
The accelerated approval for Trodelvy in this indication was initially granted in 2021 based on Phase 2 TROPHY-U-01 study findings. Continued approval, however, was contingent upon results from the TROPICS-04 study. According to Gilead, TROPICS-04 did not demonstrate a statistically significant improvement in overall survival, leading to the withdrawal.
Impact on Treatment Landscape
Dr. John L. Gore, an oncologist at the University of Washington Medical Center and Fred Hutchinson Cancer Center, noted the impact of this decision. "The most important thing is that one of the options we had some optimism for as another available systemic therapy for urothelial cancers, for the time being, is not going to be an option," he told CURE®.
Trodelvy is an antibody-drug conjugate (ADC) that targets specific receptors on cancer cells, delivering a cytotoxic payload directly to the tumor. Dr. Yousef Zakharia, co-leader of the Genitourinary Oncology Program at the University of Iowa, described it as a form of "targeted chemotherapy." The ADC mechanism aims to minimize damage to normal cells while maximizing the drug's impact on cancer cells.
Trodelvy's Other Indications
The withdrawal does not affect Trodelvy’s other FDA approvals for treating unresectable locally advanced or metastatic triple-negative breast cancer and hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer. This highlights that while the target receptor may be common across multiple cancers, the drug's efficacy can vary significantly.
"It's important to know even though the receptor that this is active against is common across a number of cancers, it doesn't mean it has the same activity across a number of cancers," Gore explained. "[Although] it maybe didn't work as well as we’d hoped in bladder cancer doesn't mean the same is true of breast cancer, just like just because it worked well in breast cancer doesn't mean it's automatically going to work in bladder cancer."
Guidance for Patients
Gilead advises patients currently receiving Trodelvy for metastatic urothelial cancer to consult with their healthcare providers regarding their treatment plan. Gore suggests that if patients are responding well to Trodelvy, providers may be hesitant to discontinue it, particularly in later-line settings where other treatments have been exhausted. However, the decision should be made in consultation with a physician, considering the latest clinical data.
