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: FDA approves Roche skin cancer drug Erivedge

More information: The FDA has more about this approval.


Related Stories

FDA approves Roche skin cancer drug Erivedge

January 30, 2012
(AP) -- Federal regulators on Monday approved a pill that treats the most common type of skin cancer, basal cell carcinoma.

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

Encouraging oxygen's assault on iron may offer new way to kill lung cancer cells

November 22, 2017
Blocking the action of a key protein frees oxygen to damage iron-dependent proteins in lung and breast cancer cells, slowing their growth and making them easier to kill. This is the implication of a study led by researchers ...

One-size treatment for blood cancer probably doesn't fit all, researchers say

November 22, 2017
Though African-American men are three times more likely to be diagnosed with a blood cancer called multiple myeloma, most scientific research on the disease has been based on people of European descent, according to a study ...

Combination immunotherapy targets cancer resistance

November 22, 2017
Cancer immunotherapy drugs have had notable but limited success because in many cases, tumors develop resistance to treatment. But researchers at Yale and Stanford have identified an experimental antibody that overcomes this ...

One in four U.S. seniors with cancer has had it before

November 22, 2017
(HealthDay)—For a quarter of American seniors, a cancer diagnosis signals the return of an old foe, new research shows.

Researchers discover specific tumor environment that triggers cells to metastasize

November 21, 2017
A team of bioengineers and bioinformaticians at the University of California San Diego have discovered how the environment surrounding a tumor can trigger metastatic behavior in cancer cells. Specifically, when tumor cells ...

New study points the way to therapy for rare cancer that targets the young

November 21, 2017
After years of rigorous research, a team of scientists has identified the genetic engine that drives a rare form of liver cancer. The findings offer prime targets for drugs to treat the usually lethal disease, fibrolamellar ...

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.