FDA approves first pre-surgical breast cancer drug

Federal health officials say they have approved a biotech drug from Roche as the first medicine labeled for the treatment of breast cancer before surgery.

The Food and Drug Administration approved Perjeta for women with a form of early-stage who face a high risk of having their spread to other parts of the body.

Surgery to remove tumors is usually the first step in treating most forms of cancer. Perjeta is the first drug to be approved as a pre-surgical step.

The FDA gave the drug accelerated approval based on a study showing women who received the drug as an initial treatment were more likely to be cancer-free 12 weeks later than women who received older drug combinations.

not rated yet
add to favorites email to friend print save as pdf

Related Stories

FDA: Roche drug works in early-stage breast cancer

Sep 10, 2013

The U.S. Food and Drug Administration has issued a positive review of a breast cancer drug from Roche that could soon become the first pharmaceutical option approved for treating early-stage disease before ...

FDA approves genetic test for lung cancer drug

May 14, 2013

The Food and Drug Administration says it approved a genetic test from Roche to help doctors identify patients who can benefit from a lung cancer drug made by Genentech.

Perjeta approved for advanced breast cancer

Jun 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.

Recommended for you

A new tool in drug overdose prevention

Oct 30, 2014

The Center for Disease Control reported earlier this month that the heroin overdose death rate across 28 states it surveyed doubled between 2010 and 2012. This sharp increase and the chilling statistics that say more than 11 ...

Nasal spray treats heroin overdose

Oct 28, 2014

"Every year, drug overdoses are responsible for roughly 1000 ambulance calls in Oslo," says Arne Skulberg, an anaesthesiologist, a PhD candidate at NTNU and the 2014 winner of Norway's Researcher Grand Prix ...

User 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.