The Food and Drug Administration (FDA) has approved Perjeta (pertuzumab; Genentech), for use in combination with trastuzumab (Herceptin; Genentech) and chemotherapy as adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence. 

The approval was based on the APHINITY study, a multicenter, randomized, double-blind, placebo-controlled study conducted in 4804 patients with HER2-positive early breast cancer who had their primary tumor excised prior to randomization. Patients were randomized to receive pertuzumab or placebo, in combination with adjuvant trastuzumab and chemotherapy (investigator-selected). The primary 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. 

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The results showed that after a median follow-up of 45.4 months, pertuzumab plus trastuzumab and chemotherapy significantly reduced the risk of invasive breast cancer recurrence or death by 18% compared to trastuzumab and chemotherapy alone (hazard ratio [HR] 0.82, 95% CI 0.67–1.00; P=0.047). With regard to the high-risk groups, the proportion of IDFS events in patients with hormone receptor negative disease was 8.2% in the pertuzumab arm and 10.6% in the placebo arm, (HR 0.76, 95% CI 0.56–1.04). The proportion of IDFS events for patients with node positive disease was 9.2% in the pertuzumab group and 12.1% in the placebo group (HR 0.77, 95% CI 0.62–0.96). 

Perjeta, an HER2/neu receptor antagonist, is also indicated for use in combination with trastuzumab and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. In addition, the FDA has converted the previously granted accelerated approval of the Perjeta-based regimen to full approval for neoadjuvant treatment of HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either >2cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer.

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