Frank Vinluan
Gilead Sciences is voluntarily withdrawing cancer drug Trodelvy from the U.S. market as a treatment for advanced cases of urothelial carcinoma, a move that comes nearly five months after the therapy’s failure in a confirmatory study.
Gilead made the decision in consultation with the FDA, the company said in its announcement Friday. The withdrawal in metastatic urothelial carcinoma, an aggressive form of bladder cancer, does not affect the drug’s status in its other approved indications in the U.S. as well as other markets. Foster City, California-based Gilead said clinicians will be notified of Trodelvy’s withdrawal in urothelial carcinoma, adding that patients who have this type of cancer should discuss their treatment options with their provider.
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Trodelvy is an antibody drug conjugate (ADC), a type of therapy comprised of a targeting antibody linked to a toxic drug payload. ADCs’ ability to offer targeted way of killing cancer cells has made this drug class one of the hottest areas of cancer drug research. The target of Trodelvy Gilead drug is TROP-2, a protein abundant on the surface of many types of cancer cells.
In 2021, the FDA awarded Trodelvy accelerated FDA approval for treating cases of urothelial carcinoma that is locally advanced or metastatic after treatment with chemotherapy or a type of immunotherapy called a checkpoint inhibitor. This approval was based on Phase 2 data measuring tumor response rate and duration of response. Drugs that reach the market through the accelerated approval pathway must confirm their safety and efficacy in a larger and longer Phase 3 confirmatory study.
This past May, Gilead announced Trodelvy failed its confirmatory test in urothelial carcinoma with results that fell short of statistical significance against the main goal of measuring overall survival. The company did not disclose more detail, saying only that data would be presented at a medical meeting. The data still have not been presented, but Gilead on Friday reiterated its pledge to present them at an unspecified upcoming medical meeting.
Trodelvy first reached the market in 2020 as a treatment for advanced cases of triple negative breast cancer. In 2021, the drug converted its accelerated approval to a full approval in this indication. Last year, Trodelvy expanded its label with accelerated approval for treatment of advanced HR positive HER2 negative breast cancer. But Gilead has encountered setbacks in its efforts to expand the drug’s label. At the beginning of this year, Gilead reported Trodelvy failed a Phase 3 test in non-small cell lung cancer.
Across all of its approved indications, Trodelvy accounted for more than $1 billion in sales in 2023, according to Gilead financial reports. In the first half of this year, the drug generated $628 million in revenue, a 30% increase compared to the same period in 2023. The company attributed the sales growth to higher demand in both of its approved breast cancer indications.
Gilead says Trodelvy has approvals in more than 50 countries. The drug’s clinical development program includes tests in other populations of breast cancer patients as well as lung cancer, head and neck cancer, and gynecological cancers.