The Food and Drug Administration approved drug Perjeta for pre-surgical use in treating early-stages of breast cancer on Monday.
Perjeta (pertuzumab) was originally approved in 2012 for treatment in patients with advanced or late-stage (metastatic) HER2-positive breast cancer, who have increased amounts of the HER2 protein that "contributes to cancer cell growth and survival," the FDA said in a new release.
Perjeta is the first FDA-approved drug for the neoadjuvant treatment of breast cancer:
Perjeta's new use is intended 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.
"We are seeing a significant shift in the treatment paradigm for early stage breast cancer," said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research. "By making effective therapies available to high-risk patients in the earliest disease setting, we may delay or prevent cancer recurrences.''
(Read the FDA's full news release here)
A member of the Roche Group markets the breast cancer drug; Roche has also made another major stride in cancer research and treatment.
Experimental immunotherapy drug called MPDL3280A has seen "encouraging numbers" in early-stage trial data presented at the European Cancer Congress (ECC) in Amsterdam. The treatment seemed to work best for smokers who developed lung cancer than non-smokers.
"Of 53 patients with NSCLC tumours treated with the drug, 23 percent saw their tumours shrink, according to results presented at the [ECC]," Reuters reports.
"But the most encouraging numbers were among smokers, where the response rate was 26 percent compared with 10 percent of patients who had never smoked," said Professor Jean-Charles Soria of France's Institut Gustave Roussy, who led the study.
(Read more about Roche's experimental immunotherapy drug here)
