FDA Approves Breast Cancer Medicine

(June 9, 2012) The U.S. Food and Drug Administration (FDA) approved a new anti-HER2 therapy, called Perjeta (pertuzumab) to treat patients with HER2-positive late-stage (metastatic) breast cancer.  Perjeta is combined with trastuzumab, another anti-HER2 therapy, and docetaxel, a type of chemotherapy.

 

HER2 is a protein involved in normal cell growth, and is found in increased amounts on some types of cancer cells (HER2-positive), including some breast cancers. The increased amount of HER2 protein in these HER2-positive breast cancers contributes to cancer cell growth., as well as survival.

 

Perjeta is intended for patients who have not received prior treatment for metastatic breast cancer with an anti-HER2 therapy or chemotherapy.

 

Perjeta is administered through an IV, and is a humanized monoclonal antibody, manufactured through biotechnology methods.

 

Currently, breast cancer is the second leading cause of cancer-related death among women. In fact, an estimated 226,870 women will be diagnosed this year, and 39,510 will die from the disease.

 

Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research, said,  “given the need for additional treatments for metastatic breast cancer, we made the decision to approve this drug today and not to delay its availability to patients pending resolution of the production issues relating to future supply.”

 

Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug and Research, said, “since trastuzumab was first approved more than a decade ago, continued research has allowed us to better understand the role HER2 plays in breast cancer. This research provided the background to combine two targeted drugs – trastuzuman and Perjeta with docetaxel to slow disease progression in breast cancer.”

 

In a study designed to measure the length of time a patient lived without the cancer progressing, progession-free survival (PFS), those treated with the combination containing Perjeta had a median PFS of 18.5 months, whereas those treated with the combination containing placebo had a median PFS of 12.4.

 

Common side effects are diarrhea, hair loss,  a decrease in infection-fighting white blood cells, nausea, fatigue, rash, and nerve damage.

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