FDA approves Gilead drug for metastatic breast cancer

Feb. 6, 2023

Gilead Sciences announced this week that the U.S. FDA has approved its breast cancer drug for the treatment of adults with HR+/HER2- metastatic breast cancer.

Sold as Trodelvy, the drug is a first-in-class Trop-2-directed antibody-drug conjugate. Trop-2 s a cell surface antigen that can be found in more than 90% of breast and bladder cancers, and Gilead designed Trodelvy to include a proprietary linker that enhances delivery potency to cancer cells. 

The drug is already approved in more than 40 countries, with multiple additional regulatory reviews underway worldwide, for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer.

The recent indication was supported by results from the phase 3 trial TROPiCS-02. The global, multicenter, open-label, study included 543 patients with HR+/HER2- metastatic breast cancer who had been previously treated with endocrine therapy, CDK4/6 inhibitors, and two to four lines of chemotherapy for metastatic disease. All primary and secondary endpoints were met, not only did Trodelvy improved progression-free survival for patients in comparison to chemotherapy but it also demonstrated a positive overall safety and tolerability profile. 

Gilead picked up the drug back in 2020, with its $21 billion Immunomedics buy.

Since the approval last Friday, Gilead's shares surged by nearly 3%.