Gilead Withdraws Trodelvy's Accelerated Approval for Bladder Cancer After Failed Study

Gilead Sciences has decided to withdraw the accelerated approval of its antibody-drug conjugate, Trodelvy, for treating bladder cancer. This decision follows the drug’s failure to demonstrate an improvement in survival rates for patients in a Phase 3 clinical trial conducted earlier this year. The company announced the voluntary withdrawal after discussions with the U.S. Food and Drug Administration (FDA).

While Trodelvy is primarily used for treating breast cancer, its indication for bladder cancer represents a smaller portion of its total sales. Despite this, the withdrawal comes amid growing criticism of Gilead's recent business decisions. A significant focus of concern from Wall Street lies in the company’s acquisition of Immunomedics for $21 billion in 2020, a move that brought Trodelvy under Gilead’s portfolio. Last year alone, Trodelvy generated $1.1 billion in sales, and Gilead has referred to it as a “cornerstone” of their cancer treatment lineup.

In 2021, the FDA had granted accelerated approval to Trodelvy for patients with locally advanced or metastatic urothelial cancer who had previously undergone platinum-based chemotherapy and a checkpoint inhibitor. However, in May, Gilead revealed that Trodelvy did not show a survival benefit for bladder cancer patients compared to standard chemotherapy. The study also reported a higher number of deaths in the Trodelvy treatment group, primarily due to infections caused by low white blood cell counts, a known and serious side effect of the drug.

Gilead plans to present detailed data from the bladder cancer study at an upcoming medical conference. Earlier in January, the company also reported that Trodelvy failed to meet expectations in a pivotal study for non-small cell lung cancer, which was a setback for their plans to expand the uses of the drug.

Additionally, Gilead recorded a $2.4 billion loss earlier this year, tied to assets from the Immunomedics acquisition. The company has faced challenges in its efforts to expand its oncology pipeline. In 2020, Gilead spent $4.9 billion to acquire Forty Seven Inc. and its experimental CD47-targeted cancer drug. However, Gilead ceased development of the drug, known as magrolimab, this year after it failed to improve survival in pivotal blood cancer studies and presented concerning safety risks.

In related news, Gilead announced in July that its chief medical officer, Merdad Parsey, would be departing from the company in early 2025. This leadership change comes at a critical time as Gilead navigates the challenges and criticisms surrounding its recent business strategies and drug development efforts.