FDA approves Perjeta for neoadjuvant Breast Cancer
The FDA on 30 September 2013, granted accelerated approval to Perjeta (pertuzumab) from Genentech/Roche as part of a complete treatment regimen for patients with early stage Breast Cancer before surgery (neoadjuvant setting). Perjeta is the first FDA-approved drug for the neoadjuvant treatment of Breast Cancer.
Perjeta was approved in 2012 for the treatment of patients with advanced or late-stage (metastatic) HER2-positive Breast Cancer. HER2-positive breast cancers have increased amounts of the HER2 protein that contributes to cancer cell growth and survival. Perjeta�s new use is intended for patients with HER2-positive, locally advanced, inflammatory or early stage Breast Cancer (tumour 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.
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