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

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.

APHINITY

Approval was based on data from the APHINITY trial, a multicenter, randomized, double-blind, placebo-controlled trial in 4,804 patients with HER2-positive early breast cancer who had their primary tumor excised prior to randomization. Patients were then randomized to receive pertuzumab or placebo in combination with adjuvant trastuzumab and chemotherapy. The main efficacy outcome was invasive disease–free survival (IDFS), defined as the time from randomization to first occurrence of ipsilateral local or regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, or death from any cause.

After a median follow-up of 45.4 months, the proportion of IDFS 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). High-risk patients included patients such as those classified as hormone receptor–negative or those with node-positive breast cancer. The proportion of IDFS 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 IDFS 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). Overall survival data are not yet mature.

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, decreased neutrophil count, anemia, decreased white blood cell count, leukopenia, fatigue, nausea, and stomatitis.

The initial pertuzumab dose is 840 mg administered as a 60-minute intravenous infusion, followed every 3 weeks thereafter by 420 mg administered as a 30- to 60-minute intravenous infusion.

Full prescribing information is available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125409s113s118lbl.pdf.

In 2012, FDA granted regular approved to pertuzumab for use in combination with trastuzumab and docetaxel for treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.

FDA granted accelerated approval to pertuzumab in 2013 as neoadjuvant treatment. With this latest adjuvant approval, the accelerated approval post-marketing requirement is fulfilled and regular approval is granted to pertuzumab for use in combination with trastuzumab and chemotherapy as neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early-stage breast cancer (either greater than 2 cm in diameter or node-positive) as part of a complete treatment regimen for early breast cancer.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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