The FDA has granted Priority Review status to pertuzumab (Perjeta) for the treatment of HER2-positive early breast cancer. The FDA will review the agent in combination with trastuzumab and chemotherapy, for use in the adjuvant setting.
The US Food and Drug Administration (FDA) has granted Priority Review status to pertuzumab (Perjeta, Genentech) for the treatment of HER2-positive early breast cancer. The FDA will review the agent in combination with trastuzumab and chemotherapy, for use in the adjuvant setting.
“The goal of treating breast cancer early is to provide people with the best chance for a cure,” said Sandra Horning, MD, chief medical officer of the drug’s developer, in a press release. “Despite advances in the treatment of this disease, many people treated with the current standard of care still see their cancer return.”
The Priority Review was granted based on results of the phase III APHINITY trial. The trial, which included 4,804 HER2-positive breast cancer patients, was presented earlier this year at the 2017 American Society of Clinical Oncology Annual Meeting in Chicago, and published simultaneously in the New England Journal of Medicine.
Investigators randomized patients to receive pertuzumab, trastuzumab, and chemotherapy (2,400 patients), or placebo along with trastuzumab and chemotherapy (2,404 patients). They were followed for a median of 45.4 months.
In the pertuzumab group there were 171 invasive disease-free survival (iDFS) events at 3 years, compared with 210 in the placebo group, resulting in a hazard ratio for iDFS of 0.81 (95% CI, 0.66–1.00; P = .045). Among the 3,005 patients who were node-positive, the HR for iDFS was 0.77 (95% CI, 0.62–0.96; P = .019), while it was not significantly different between the groups for node-negative patients, or for a subgroup of hormone receptor–positive patients.
Grade 3 or higher adverse events (AEs) occurred in 64.2% of pertuzumab patients and in 57.3% of placebo patients; 0.8% of each group suffered a fatal AE. Primary cardiac events were slightly more common with pertuzumab, at 0.7% compared with 0.3%. The most common severe AEs included neutropenia, febrile neutropenia, and diarrhea.
Pertuzumab is already approved in combination with trastuzumab and docetaxel as neoadjuvant treatment for HER2-positive, locally advanced, inflammatory, or early-stage breast cancer, and in the same regimen for the treatment of HER2-positive metastatic disease who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. The FDA will make a determination on the new indication by January 28, 2018.