FDA prepares to approve Perjeta for use pre-surgery

September 19, 2013

The Food and Drug Administration’s (FDA) advisory committee cleared the way for the approval of pertuzumab (Perjeta) to treat patients before they have surgery to remove their HER2-positive tumors. If approved, pertuzumab would be the first neoadjuvant drug approval for any form of cancer. The drug was already approved by the FDA for treatment of late-stage breast cancer last year.

 

The Food and Drug Administration’s (FDA) advisory committee cleared the way for the approval of pertuzumab (Perjeta) to treat patients before they have surgery to remove their HER2-positive tumors. If approved, pertuzumab would be the first neoadjuvant drug approval for any form of cancer. The drug was already approved by the FDA for treatment of late-stage breast cancer last year.

The drug would be used only on a minority of patients, particularly those with large tumors or other serious risk factors. According to the drug’s manufacturer, it would be indicated account for roughly 15,000 women out of the 220,000 new cases of early-stage breast cancer.

The recommendation was based on 2 Phase II studies of pertuzumab in high-risk, HER2-positive early-stage breast cancer. A Phase III study evaluating the effectiveness of the drug after surgery is ongoing, with data expected in 2016.

Some of the committee’s members expressed concern over potential cardiac effects of the drug.

 

 

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