March 26, 2018

FDA Approves Perjecta for Adjuvant Treatment of HER2-positive Breast Cancer

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CancerConnect News: On December 20, 2017, the Food and Drug Administration granted regular approval to Perjeta (pertuzumab) for use in combination with Herceptin (trastuzumab) and chemotherapy as adjuvant treatment of patients with HER2-positive early stage breast cancer at high risk of recurrence.

About Perjeta

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.

Perjeta is given intravenously and targets the HER2 protein. It was approved in 2012 for the treatment of patients with advanced or late-stage (metastatic) HER2-positive breast cancer. Its 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 Herceptin® and other chemotherapy prior to surgery and, depending upon the treatment regimen used, may be followed by chemotherapy after surgery.

Approval of Perjeta was based on data from the APHINITY multicenter, clinical trial performed in 4804 patients with HER2-positive early stage breast cancer who had their primary tumor removed by surgery. Patients were then treated with either Perjeta or placebo, in combination with adjuvant both Herceptin and chemotherapy.

In the current trial patients were followed for evidence of invasive disease-free survival (IDFS) – defined as the time to first occurrence of cancer recurrence, development of a contralateral invasive breast cancer, or death from any cause.

After a median follow-up of 45.4 months, the proportion of IDFS events was 7.1% for Perjeta caompared to 8.7% (n=210) for those receiving placebo.  High-risk patients included patients such as those with hormone receptor negative or those with node positive breast cancer. The proportion of IDFS events in patients with hormone receptor negative disease was 8.2% for Perjeta compared to 10.6% for placebo. The proportion of IDFS events for patients with node positive disease was 9.2% for Perjeta and 12.1% for placebo.  Overall survival data are not yet mature.

Reference: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm358301.pdf.

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Tags: Breast Cancer, HER-2, neu positive, News, perjeta, pertuzumab, Uncategorized