Perjeta OK’d for Adjuvant Treatment of Certain Breast Cancer Cases

Accelerated approval for neoadjuvant use also converted to full approval

The FDA has approved pertuzumab (Perjeta, Genetech), in combination with trastuzumab (Herceptin, Genentech) and chemotherapy, for adjuvant treatment of HER2-positive early breast cancer at high risk of recurrence. People should receive the adjuvant pertuzumab-based regimen for one year.

The FDA also converted the previously granted accelerated approval of the pertuzumab-based regimen to full approval for neoadjuvant treatment of HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node-positive). People receiving the neoadjuvant pertuzumab-based regimen should continue pertuzumab and trastuzumab after surgery to complete one year of treatment.

The FDA-approved use of the pertuzumab-based regimen for adjuvant treatment of HER2-positive early breast cancer at high risk of recurrence is based on results of the phase 3 APHINITY study. At the time of the primary analysis, with a median of 45.4 months follow-up, pertuzumab, trastuzumab, and chemotherapy significantly reduced the risk of invasive breast cancer recurrence or death by 18% in the overall study population compared to trastuzumab and chemotherapy alone (hazard ratio [HR], 0.82; 95% confidence interval [CI], 0.67–1.00, P = 0.047).

Results were also analyzed for high-risk patient groups: lymph node-positive (HR, 0.77; 95% CI, 0.62–0.96); hormone receptor-negative (HR, 0.76; 95% CI, 0.56–1.04); hormone receptor-positive, (HR, 0.86; 95% CI, 0.66–1.13); and lymph node-negative (HR, 1.13; 95% CI, 0.68–1.86).

The most common grade 3–4 side effects with the pertuzumab-based regimen are low levels of white blood cells with or without a fever, diarrhea, decrease in certain types of white blood cells, decrease in red blood cells, fatigue, nausea, and mouth blisters or sores. The most common side effects are diarrhea, nausea, hair loss, fatigue, nerve damage, and vomiting.

The supplemental biologics license application for the pertuzumab-based regimen for adjuvant treatment of HER2-positive early breast cancer was granted priority review by the FDA.

Pertuzumab is also approved for use in combination with trastuzumab and docetaxel in people who have HER2-positive metastatic breast cancer and who have not received anti-HER2 therapy or chemotherapy for metastatic breast cancer.

Source: Genentech; December 20, 2017.