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FDA grants Genentech's Perjeta® (pertuzumab) accelerated approval for use before surgery in people with HER2-positive early stage breast cancer
Date:10/1/2013

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Background on Neoadjuvant Treatment:

Upon receiving an early stage breast cancer diagnosis, a person typically undergoes surgery and may then receive a medicine in the "adjuvant" (post-surgery) setting. Neoadjuvant treatment is another treatment option given after diagnosis but before surgery. Neoadjuvant treatment may allow a doctor to quickly access whether a medicine is working, and may also reduce a tumor's size so it is easier to surgically remove.

WHY THIS APPROVAL IS IMPORTANT

  • Treating people with breast cancer early, before the cancer has spread, may offer the best chance of preventing the disease from returning.
  • The Perjeta regimen is the first treatment approved under a new FDA pathway for neoadjuvant use in breast cancer.
  • This new approval pathway makes Perjeta available to people with high-risk, early stage breast cancer more quickly than is possible with traditional approvals.
  • HER2-positive breast cancer is a particularly aggressive form of the disease that affects approximately 25 percent of people with breast cancer.


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Contact: Russell Grant
grantr@fleishman.com
212-453-2430
Fleishman-Hillard
Source:Eurekalert

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