The U.S. Food and Drug Administration (FDA) has approved Perjeta® (pertuzumab) for the treatment of HER2-positive, metastatic breast cancer. The drug is approved for use in combination with Herceptin® (trastuzumab) and docetaxel chemotherapy in patients who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.
Breast cancer is the second leading cause of cancer-related death among women. This year an estimated 226,870 women will be diagnosed with breast cancer, and 39,510 will die from the disease. Approximately 20-25 percent of breast cancers overexpress (make too much of) the human epidermal growth factor receptor 2 (HER2), which is part of a biological pathway involved in growth and spread of cancer cells.
HER2-targeted therapies such as Herceptin have dramatically improved outcomes for women with HER2-positive breast cancer, but researchers continue to explore new approaches to treatment.
Perjeta is given intravenously and targets a different part of the HER2 protein than Herceptin. Since the two drugs target different regions of HER2, they are believed to work in a way that is complementary to each other.
The approval was based on data from an international, phase III, randomized, double-blind, placebo-controlled study that involved 808 patients with HER2-positive metastatic breast cancer. Patients were randomly assigned to receive Perteja/Herceptin/docetaxel or Herceptin/docetaxel/placebo. The results indicated that patients who received the combination of Perjeta/Herceptin/docetaxel lived longer without their cancer getting worse—median progression-free survival (PFS) in the Perjeta group was 18.5 months compared to 12.4 months in the placebo group.
The most common adverse events in patients receiving Perteja in combination with Herceptin and docetaxel were diarrhea, hair loss, low white blood cell count, nausea, fatigue, rash, and peripheral neuropathy (numbness or tingling in the extremities).
Perteja will include a Boxed Warning, which will alert patients and physicians to the potential risk of death or severe defects to a fetus. It is imperative to confirm a negative pregnancy status prior to starting treatment with Perjeta.
The drug was reviewed under the agency’s priority review program, which allows an expedited six-month review of drugs that may offer major advances in treatment.
FDA approves Perjeta for type of late-stage breast cancer [FDA News Release]. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm307549.htm
Posted June 18, 2012