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.

Related Stories

FDA: Roche drug works in early-stage breast cancer

date 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

date 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

date 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

Mylan rebuffs Teva again; calls bid low, insincere

date 19 hours ago

Generic drug company Mylan rejected for the second time Monday a $40.1 billion takeover offer from Israeli pharmaceutical power Teva, just days after Mylan's own bid for rival Perrigo was rebuffed.

Rising antibiotic shortages raise concerns about patient care

date Apr 23, 2015

Shortages of key antibiotics, including gold-standard therapies and drugs used to treat highly resistant infections, are on the rise, according to a new study of shortages from 2001 to 2013 published in Clinical Infectious Di ...

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.