Combination therapy for breast cancer accelerated

Genentech announced the FDA has approved Perjeta (pertuzumab), in combination with Herceptin (trastuzumab) and chemotherapy (the Perjeta-based regimen), for adjuvant (after surgery) treatment of HER2-positive early breast cancer (EBC) at high risk of recurrence. People should receive the adjuvant Perjeta-based regimen for one year (up to 18 cycles). The FDA has also converted the previously granted accelerated approval of the Perjeta-based regimen to full approval for neoadjuvant (before surgery) treatment of HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than two centimeters in diameter or node-positive). People receiving the neoadjuvant Perjeta-based regimen should continue Perjeta and Herceptin after surgery to complete one year of treatment.

The FDA-approved use of the Perjeta-based regimen for adjuvant treatment of HER2-positive EBC at high risk of recurrence is based on results of the Phase III APHINITY study. At the time of the primary analysis with a median of 45.4 months follow-up, in the overall study population, Perjeta, Herceptin and chemotherapy significantly reduced the risk of invasive breast cancer recurrence or death by 18 percent compared to Herceptin and chemotherapy alone (HR=0.82, 95% CI 0.67-1.00, p=0.047). High-risk patients included patients such as those with lymph node-positive or hormone receptor-negative breast cancer.

The most common severe (Grade 3-4) side effects with the Perjeta-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.