Gilead Sciences Withdraws Bladder Cancer Drug After Trial Failure

Gilead Sciences has decided to voluntarily withdraw its cancer drug Trodelvy from the U.S. market as a treatment for advanced urothelial carcinoma. This decision follows nearly five months after the drug failed a confirmatory study. Gilead announced this decision in collaboration with the FDA, emphasizing that the withdrawal pertains only to metastatic urothelial carcinoma, an aggressive form of bladder cancer. The drug’s status for other approved indications in the U.S. and other markets remains unchanged. Gilead, based in Foster City, California, plans to notify clinicians of this withdrawal and advises patients with urothelial carcinoma to consult their healthcare providers for alternative treatment options.

Trodelvy is an antibody-drug conjugate (ADC), a class of cancer therapy that involves a targeting antibody connected to a toxic drug payload. ADCs are designed to deliver the toxic drug specifically to cancer cells, minimizing damage to normal cells. Trodelvy targets TROP-2, a protein commonly found on the surface of various cancer cells.

In 2021, the FDA granted Trodelvy accelerated approval for treating locally advanced or metastatic urothelial carcinoma, provided that the patients had previously undergone chemotherapy or a checkpoint inhibitor, a type of immunotherapy. This approval was based on Phase 2 clinical trial data that assessed tumor response rate and duration of response. However, drugs approved through the accelerated approval pathway must demonstrate their safety and efficacy in more extensive Phase 3 confirmatory studies.

In May of this year, Gilead disclosed that Trodelvy did not meet the primary endpoint of overall survival in its Phase 3 confirmatory trial for urothelial carcinoma. The company provided little detail on the data, only stating that the results would be shared at a future medical meeting. Although the data have yet to be presented, Gilead reiterated its commitment to disclose the findings at an upcoming medical conference.

Trodelvy was initially approved in 2020 for treating advanced triple-negative breast cancer. In 2021, the drug transitioned from accelerated to full approval for this indication. Last year, Trodelvy received accelerated approval for treating advanced HR positive HER2 negative breast cancer. However, Gilead has faced challenges in expanding Trodelvy's use for other cancers. Early this year, Gilead reported that Trodelvy did not succeed in a Phase 3 trial for non-small cell lung cancer.

Despite these setbacks, Trodelvy has generated significant revenue for Gilead. In 2023, the drug’s sales exceeded $1 billion across all approved indications. In the first half of this year, Trodelvy brought in $628 million in revenue, marking a 30% increase compared to the same period in 2023. Gilead attributed this growth to higher demand for the drug in both of its approved breast cancer indications.

Trodelvy is approved in over 50 countries, and its clinical development program is ongoing. The drug is currently being tested in additional populations of breast cancer patients as well as individuals with lung cancer, head and neck cancer, and gynecological cancers.

In conclusion, while Trodelvy’s withdrawal for urothelial carcinoma represents a setback, the drug continues to be a significant player in the cancer treatment landscape, with ongoing trials and approvals in various cancer types. Gilead's focus remains on providing effective treatment options and expanding the clinical utility of Trodelvy.