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Gilead Sciences Files for Trodelvy FDA Approval in HR-Positive Breast Cancer, Buys Rights in Asia

NEW YORK – Gilead Sciences said on Monday that, following new clinical data on overall survival benefit, it has submitted a supplemental biologics licensing application to the US Food and Drug Administration for its antibody-drug conjugate Trodelvy (sacituzumab govitecan) for previously treated hormone receptor (HR)-positive, HER2-negative metastatic breast cancer.

Results from a planned interim analysis showed that in the Phase III TROPiCS-02 trial Trodelvy significantly improved overall survival — the trial's secondary endpoint — versus physician's choice of chemotherapy for patients with HR-positive, HER2-negative metastatic breast cancer who received prior endocrine therapy, CDK4/6 inhibitors, and two to four lines of chemo.

Foster City, California-based Gilead is waiting until an upcoming medical conference to share the full results, though it has already submitted them to the FDA and plans to share them with health authorities outside the US, too.

Though Trodelvy is not yet approved in this patient population, the National Comprehensive Cancer Network added the treatment to its breast cancer guidelines in June based on the progression-free survival results from TROPiCS-02 presented during the American Society of Clinical Oncology annual meeting.

In 2020, the FDA granted accelerated approval to Trodelvy for metastatic triple-negative breast cancer, and European regulators followed suit the next year. The TROP2-directed therapy is also approved for certain advanced urothelial carcinoma patients.

Separately on Monday, Gilead announced plans to acquire the remaining worldwide rights to Trodelvy from Everest Medicines, including rights to develop and commercialize the drug in greater China, South Korea, Singapore, Indonesia, the Philippines, Vietnam, Thailand, Malaysia, and Mongolia.

Trodelvy is approved for metastatic TNBC in China and Singapore, and Gilead says it is working closely with regulatory bodies in Hong Kong, South Korea, and Taiwan to net approvals in those regions, where marketing applications filed by Everest Medicines are already under review.

Everest Medicines has held rights to Trodelvy in these regions of Asia since 2019, when it inked an agreement with Trodelvy's former developer, Immunomedics. Gilead then acquired Immunomedics in 2020, gaining rights to develop the drug in all other countries.

Under the terms of the new agreement, Gilead will pay $280 million upfront to Everest. Everest will be eligible for an additional $175 million in milestone payments, and Gilead will be able to recruit Everest employees who are working on the Trodelvy program.

According to Gilead, the final transaction is expected to close later this year contingent on approval from Everest's shareholders.