FDA Gives Priority Review for HR+, HER2– Advanced Breast Cancer Therapy

The FDA granted priority review to a supplemental biologics license application for sacituzumab govitecan-hziy in treating HR-positive, HER2-negative locally advanced or metastatic breast cancer after failure with endocrine therapy and at least two lines of other systemic therapies, according to an announcement from the drug’s manufacturer.

Gilead based its application on findings from the TROPiCS-02 study, a global phase 3 trial evaluating the efficacy of sacituzumab govitecan-hziy compared with that of physician’s choice of chemotherapy in patients with advanced, heavily pretreated HR-positive, HER2-negative breast cancer.

Sacituzumab govitecan-hziy reportedly reduced the risk for disease progression or death by 34% compared with chemotherapy (median PFS = 5.5 vs 4 months; HR = 0.66; 95% CI, 0.53-0.83; P = .0003) and reduced the risk for death by 21% (OS = 14.4 months vs 11.2 months; HR = 0.789; 95% CI, 0.646-0.964; P = .02).

HR-positive, HER2-negative breast cancer is the most common type of breast cancer, with the National Cancer Institute estimating that this cancer accounts for more than two-thirds of all breast cancers.

“[Sacituzumab govitecan-hziy] has already changed the treatment landscape in second-line metastatic triple-negative breast cancer and pre-treated metastatic urothelial cancer, and today’s news marks our third supplemental application acceptance within the last two years,” Bill Grossman, MD, PhD, senior vice president and therapeutic area head at Gilead Oncology, said in the press release announcing the priority review.

The FDA is set to respond to the application in February of 2023.
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References:
https://investors.gilead.com/news/news-details/2022/U.S.-FDA-Accepts-for-Priority-Review-the-Supplemental-Biologics-License-Application-for-Gileads-Trodelvy-for-Pre-Treated-HRHER2--Metastatic-Breast-Cancer/default.aspx
https://clinicaltrials.gov/ct2/show/NCT03901339
https://seer.cancer.gov/statfacts/html/breast-subtypes.html

Disclosures: Grossman is an employee of Gilead Sciences. TROPiCS-02 is being supported by Gilead Sciences.

Photo Credit: Getty Images.

By Andrew John, MD /alert Contributor

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