FDA Grants Regular Approval to Pertuzumab for Adjuvant Treatment of HER2-Positive Breast Cancer


Get Permission


On December 20, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to pertuzumab (Perjeta) for use in combination with trastuzumab (Herceptin) and chemotherapy as adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence.

Approval was based on data from the multicenter APHINITY trial (NCT01358877) in 4,804 patients with HER2-positive early breast cancer who had their primary tumor excised prior to randomization.1 Patients were randomized to receive pertuzumab or placebo, in combination with adjuvant trastuzumab and chemotherapy. The main efficacy outcome was invasive disease–free survival.

Study Results

After a median follow-up of 45.4 months, the proportion of invasive disease events in the intent-to-treat population was 7.1% (n = 171) in the pertuzumab arm and 8.7% (n = 210) for those receiving placebo (hazard ratio [HR] = 0.82; 95% confidence interval [CI] = 0.67, 1.00; P = .047). Patients at high risk included those with hormone receptor–negative disease or those with node-positive breast cancer. The proportion of invasive disease events in patients with hormone receptor–negative disease was 8.2% (n = 71) and 10.6% (n = 91) in the pertuzumab and placebo arms, respectively (HR = 0.76, 95%, CI = 0.56–1.04). The proportion of invasive disease events for patients with node-positive disease was 9.2% (n = 139) and 12.1% (n = 181) in the pertuzumab and placebo arms, respectively (HR = 0.77, 95% CI = 0.62–0.96).

Adverse reactions reported in at least 30% of patients receiving pertuzumab in combination with trastuzumab and chemotherapy in APHINITY were diarrhea, nausea, alopecia, fatigue, peripheral neuropathy, and vomiting. The most common grade 3-4 adverse reactions (>2%) were neutropenia, febrile neutropenia, diarrhea, neutrophil count decreased, anemia, white blood cell count decreased, leukopenia, fatigue, nausea, and stomatitis.

Previous Indications

In 2012, the FDA granted regular approval to pertuzumab combined with trastuzumab and docetaxel for patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. The FDA granted accelerated approval to pertuzumab in 2013 as neoadjuvant treatment.

Reference

1. von Minckwitz G, Procter M, de Azambuja E, et al: N Engl J Med 377:122–131, 2017.


Advertisement

Advertisement



Advertisement