The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Perjeta (pertuzumab) as part of a complete treatment regimen for patients with early stage breast cancer prior to surgery (neoadjuvant setting). Perjeta is the first FDA-approved drug for the neoadjuvant treatment of breast cancer.
The drug is already on the market, having been approved last year for the treatment of patients with advanced or late-stage (metastatic) HER2-positive breast cancer.
A new early-stage treatment
This latest FDA indication for Perjeta is meant for patients with HER2-positive, locally advanced, inflammatory or early stage breast cancer (tumor greater than 2 cm in diameter or with positive lymph nodes) who are at high risk of having their cancer return or spread (metastasize) or of dying from the disease. It is to be used in combination with trastuzumab and other chemotherapy prior to surgery and, depending upon the treatment regimen used, may be followed by chemotherapy after surgery. Following surgery, patients should continue to receive trastuzumab to complete one year of treatment.
Said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research:
We are seeing a significant shift in the treatment paradigm for early stage breast cancer. By making effective therapies available to high-risk patients in the earliest disease setting, we may delay or prevent cancer recurrences.
Trial for accelerated approval
In May of 2012, the FDA issued a draft guidance about the use of pathologic complete response (pCR), defined as the absence of invasive cancer in the breast and lymph nodes, as an endpoint to support accelerated approval of a drug for neoadjuvant treatment of high-risk, early stage breast cancer. Under the FDA’s accelerated approval program, patients are provided access to promising drugs to treat serious or life-threatening conditions while confirmatory clinical trials are conducted.
Perjeta’s accelerated approval for neoadjuvant treatment is based on a study designed to measure pCR. In the study, 417 participants were randomly assigned to receive one of four neoadjuvant treatment regimens: trastuzumab plus docetaxel, Perjeta plus trastuzumab and docetaxel, Perjeta plus trastuzumab or Perjeta plus docetaxel. About 39 percent of participants who received Perjeta plus trastuzumab and docetaxel achieved pCR, compared to about 21 percent who received trastuzumab plus docetaxel.
Meanwhile, the confirmatory trial for the accelerated approval of Perjeta is currently being conducted in participants with HER2-positive breast cancer who had prior breast cancer surgery and are at high risk of having their cancer return. More than 4,800 participants are enrolled in this trial, which will provide further data on efficacy, safety and long-term outcomes. Results are expected in 2016.
The information provided on CancerTreatment.net is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her health professional. This information is solely for informational purposes and does not constitute the practice of medicine. We encourage all visitors to see a licensed physician or nutritionist if they have any concerns regarding health issues related to diet, personal image and any other topics discussed on this site. Neither the owners or employees of CancerTreatment.net nor the author(s) of site content take responsibility for any possible consequences from any treatment, procedure, exercise, dietary modification, action or application of medication which results from reading this site. Always speak with your primary health care provider before engaging in any form of self treatment. Please see our Legal Statement for further information.