Perjeta approved by FDA for early-stage breast cancer

Farydak (panobinostat) now FDA-approved for multiple myeloma
Farydak (panobinostat) now FDA-approved for multiple myeloma

(HealthDay News) -- The drug Perjeta (pertuzumab) has been approved by the U.S. Food and Drug Administration to treat early-stage breast cancer before surgery, the agency said Monday.

In 2012, the drug was approved to treat advanced or late-stage (metastatic) HER2 (human epidermal growth factor receptor 2)-positive breast cancer, the FDA said in a news release.

The drug's new use is meant for people with HER2-positive early-stage breast cancer who are at increased risk of the cancer returning or spreading or of dying from the disease, the agency said. The drug is to be used in combination with chemotherapy before surgery.

Perjeta's safety and effectiveness were evaluated for the new use in a clinical study involving 417 people, the FDA said. A confirmatory study involving more than 4,800 people is ongoing, with results expected in 2016.

Perjeta is marketed by San Francisco-based Genentech, a member of the Roche Group.

More Information

Loading links....
You must be a registered member of ONA to post a comment.

Sign Up for Free e-newsletters

Regimen and Drug Listings


Bone Cancer Regimens Drugs
Brain Cancer Regimens Drugs
Breast Cancer Regimens Drugs
Endocrine Cancer Regimens Drugs
Gastrointestinal Cancer Regimens Drugs
Genitourinary Cancer Regimens Drugs
Gynecologic Cancer Regimens Drugs
Head and Neck Cancer Regimens Drugs
Hematologic Cancer Regimens Drugs
Lung Cancer Regimens Drugs
Other Cancers Regimens
Rare Cancers Regimens
Skin Cancer Regimens Drugs