FDA Approves Perjeta to Treat Advanced Breast Cancer

Article date: June 13, 2012

By Stacy Simon

The US Food and Drug Administration (FDA) has approved a new drug, Perjeta (pertuzumab), to treat HER2-positive breast cancer that has metastasized (spread to other parts of the body). HER2 is a growth-promoting protein that can be present on the surface of the breast cancer cells. Breast cancers with too much of this protein tend to grow and spread more aggressively. The new drug is intended for patients who have not previously received treatment for metastatic breast cancer with chemotherapy or an anti-HER2 drug like Herceptin (trastuzumab) or Tykerb (lapatinib).

Perjeta is given intravenously and is meant to be combined with Herceptin and docetaxel (Taxotere), a type of chemotherapy. Perjeta is believed to work by targeting a different part of the HER2 protein than Herceptin, resulting in further reduction in growth and survival of HER2-positive breast cancer cells. The treatment was tested in a clinical trial involving more than 800 women. Those who received all 3 drugs delayed a worsening of their breast cancer by an average of about 1 ½ years. Those who received Herceptin and docetaxel without Perjeta delayed a worsening of their breast cancer by an average of about a year.

Genentech manufactures Perjeta and Herceptin and funded the trial. Genentech said the drug would be available to patients in about 2 weeks, however, the company warned that problems with its manufacturing process could result in a shortage after current supplies run out. The company said it is working with the FDA to resolve the production issues and make sure patients who need the drug will be able to get it.

The most common side effects reported by people taking the 3-drug combination of Perjeta, Herceptin, and docetaxel were diarrhea, hair loss, a decrease in infection-fighting white blood cells, nausea, fatigue, rash, and nerve damage. Pregnant women should not take Perjeta.

Reviewed by: Members of the ACS Medical Content Staff

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