Date Published: 8 June 2012

Perjeta (pertuzumab) approved to treat HER2-positive metastatic breast cancer

The United States Food and Drug Administration (FDA) has approved the drug Perjeta for a type of late-stage breast cancer. Perjeta (pertuzumab) is a new anti-HER2 therapy to treat patients with HER2-positive late-stage (metastatic) breast cancer.

According to the FDA, Perjeta is intended for patients who have not received prior treatment for metastatic breast cancer with an anti-HER2 therapy or chemotherapy. Perjeta is combined with trastuzumab, another anti-HER2 therapy, and docetaxel, a type of chemotherapy.

HER2 is a protein that is involved in normal cell growth. It is found in larger quantities in some types of cancer cells (HER2-positive), including some breast cancers. In these HER2-positive breast cancers, the increased amount of the HER2 protein contributes to cancer cell growth and survival.

Perjeta is a humanized monoclonal antibody, manufactured through biotechnology methods. It is administered intravenously - which means by injection directly into the bloodstream. It is thought to work by targeting a different part of the HER-protein than trastuzumab, resulting in further reduction in growth, and reduced survival of HER2-positive breast cancer cells.

Due to manufacturing issues that could adversely affect long-term supply of the drug, the FDA limited its recent approval (on 8 June 2012) to a drug product that has not been affected by those known production issues. Genentech, the manufacturer of Perjeta, has agreed to take action to resolve any supply problems as quickly as reasonably possible.

" 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," said Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research.
" Genentech is currently developing a plan to mitigate the effect on patients of any potential shortage of Perjeta."

" 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," said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research.
" This research provided the background to combine two targeted drugs ? trastuzumab and Perjeta with docetaxel to slow disease progression in breast cancer."

The safety and effectiveness of Perjeta were evaluated in a single clinical trial involving 808 patients with HER2-positive metastatic breast cancer who were tested prior to treatment to determine if the HER2 protein was increased. Patients were randomly assigned to receive Perjeta, trastuzumab and docetaxel or trastuzumab and docetaxel with a placebo. The research study was designed to measure the length of time a patient lived without the cancer progressing, progression-free survival (PFS). Those treated with the combination containing Perjeta had a median PFS of 18.5 months, while those treated with the combination containing placebo had a median PFS of 12.4.

Side-effects of Perjeta

The most common side-effects that have been observed so far in patients receiving Perjeta in combination with trastuzumab and docetaxel are:

• diarrhea,
• hair loss,
• reduction in the quantity of infection-fighting white blood cells (leucocytes),
• nausea,
• fatigue,
• skin rash, and
• nerve damage (peripheral sensory neuropathy).

Although Perjeta has been approved by the FDA, it is supplied with a Boxed Warning alerting patients and health care professionals to the "potential risk of death or severe effects to a fetus". Pregnancy status must be verified prior to the start of Perjeta treatment.

This drug was reviewed under the FDA's priority review program, which provides for an expedited six-month review of drugs that may offer major advances in treatment.

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