FDA Approves New Breast Cancer Drug Perjeta

New Drug Halts Disease Progression for an Average of 18.5 Months

By Matt McMillen
WebMD Health News

Reviewed by Louise Chang, MD

June 12, 2012 -- The FDA on Monday approved a new drug for the treatment of a type of late-stage breast cancer. The drug helped stop cancer growth for about six months longer than existing medications.

Pertuzumab, to be marketed under the name Perjeta, targets the HER2 protein, which is found in greater-than-normal amounts in one in five breast cancers. These high levels of the protein speed the advance of the disease.

Taken with existing medications, Perjeta stops cancer growth for an average of 18.5 months. That's six months longer than when taking the existing medications alone.

The approval follows a single clinical trial that enrolled 808 women with HER2-positive metastatic breast cancer. All of the participants received trastuzumab (Herceptin) and docetaxel, half of them in combination with Perjeta, the other half with a placebo. Those taking Perjeta showed a significantly longer progression-free survival rate. The Perjeta group also had a 38% reduction in the risk of their disease worsening or death compared to those in the placebo group.

Perjeta's approval came after an expedited review process that FDA reserves for experimental drugs that have the potential to offer "major advances in treatment," according to an agency news release.

Breast cancer is the second deadliest cancer for women, after lung cancer. The American Cancer Society estimates that more than 226,000 women will be diagnosed with the disease this year. Nearly 40,000 will die from it. While Genentech states that the drug will be available to patients within two weeks, production issues may affect its supply. Parent company Roche says work is underway to resolve the problem, which they describe as a "cell growth issue."

"We take this very seriously and are working with the FDA to ensure a consistent manufacturing process that maintains drug supply for the people who need it," Patrick Y. Yang, PhD, head of Roche's Pharma Global Technical Operations, says in a statement.

"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," Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, says in the FDA news release.

The FDA has placed a black box warning, the FDA's most serious warning, that the new drug, which is administered intravenously, may be harmful or fatal to a fetus. Women who are pregnant should not take Perjeta.

The most common side effects, when taken in combination with Herceptin and docetaxel, include: diarrhea, hair loss, a decrease in infection-fighting white blood cells, nausea, fatigue, rash, and nerve damage (peripheral sensory neuropathy).

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SOURCES: News release, FDA. News release, Roche. Genentech: "Full Prescribing Information." American Cancer Society: "What are the key statistics about breast cancer?" American Cancer Society: "Breast cancer survival rates by stage."

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