Perjeta approved for advanced breast cancer

June 11, 2012

(HealthDay) -- Perjeta (pertuzumab) has been approved by the U.S. Food and Drug Administration to treat people with HER2-positive late-stage breast cancer, the agency said in a news release.

HER2 is a protein involved in cell growth. Increased amounts of the protein, which tend to fuel and survival, are found in about 20 percent of cases, the FDA said.

Perjeta was approved for people who haven't been previously treated with an anti-HER2 therapy for metastatic (spreading) breast cancer, the agency said.

But the FDA warned that unspecified "production issues" facing manufacturer Genentech "could affect the long-term supply of the drug." The agency said the drug maker "has committed to take steps designed to resolve these production issues in a timely manner."

The drug's safety and effectiveness were evaluated in a clinical study of 808 people with HER2-positive breast cancer. The most common side effects noted were diarrhea, hair loss, a decrease in , nausea, fatigue, rash and nerve damage.

The drug was approved with the agency's "black box" label warning of the potential for death or severe effects to a fetus. A woman's pregnancy status must be verified before she starts treatment with the drug, the FDA said.

San Francisco-based Genentech is a unit of the Roche Group.

Explore further: Herceptin targets breast cancer stem cells

More information: The FDA has more about this approval.


Related Stories

Herceptin targets breast cancer stem cells

July 9, 2008

A gene that is overexpressed in 20 percent of breast cancers increases the number of cancer stem cells, the cells that fuel a tumor's growth and spread, according to a new study from the University of Michigan Comprehensive ...

FDA says breast cancer drug did not extend lives

July 16, 2010

(AP) -- Federal health scientists said Friday that follow-up studies of a Roche breast cancer drug show it failed to slow tumor growth or extend patient lives, opening the door for a potential withdrawal in that indication.

New therapy for HER2-positive breast cancer developed

July 26, 2011

Patients with HER2-positive breast cancer may soon have an alternative therapy when they develop resistance to trastuzumab, also known as Herceptin, according to a laboratory finding published in Clinical Cancer Research.

Recommended for you

Molecularly shutting down cancer cachexia

August 30, 2016

Healthy fat tissue is essential for extended survival in the event of tumor-induced wasting syndrome (cachexia). In Nature Medicine, researchers at Helmholtz Zentrum München show that selective manipulation of an enzyme ...

Radiologists detect breast cancer in 'blink of an eye'

August 29, 2016

A new study by investigators at Brigham and Women's Hospital in collaboration with researchers at the University of York and Leeds in the UK and MD Andersen Cancer Center in Texas puts to the test anecdotes about experienced ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.