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FDA panel backs Perjeta in early breast cancer

Unanimous recommendation for use alongside Herceptin

FDA headquarters White Oak 

Roche achieved a major objective yesterday after an FDA advisory committee backed expanded used of Perjeta alongside Herceptin and docetaxel as neoadjuvant treatment for breast cancer.

The panel voted 13-0 that the combination of Perjeta (pertuzumab) and Herceptin (trastuzumab) should be approved for use before surgery in high-risk patients with early-stage, HER2-positive breast cancer.

If the FDA follows its committee's advice, Perjeta would become the cornerstone of the first regimen to get the go-ahead for neoadjuvant use in the US. The combination with Herceptin is designed to provide a more comprehensive blockade of the HER signalling pathways than Herceptin alone.

Perjeta was approved for use alongside Herceptin in treatment-naïve patients with HER2-positive, metastatic breast cancer in June 2012, bringing in sales of 108m Swiss francs ($115m) in the first half of this year.

Analysts have predicted that expansion of its use into the neoadjuvant setting could boost Perjeta to annual sales of almost $2bn by 2016.

Trials presented at the panel meeting showed that the combination of Perjeta, Herceptin and docetaxel achieved a pathological complete response (pCR) in just under 40 per cent of patients - defined as the absence of invasive cancer in the breast - compared to 21.5 per cent in patients on Herceptin plus docetaxel alone.

The use of pCR as an endpoint instead of the more usual progression-free survival (PFS) raised some eyebrows amongst the panel.

Roche is however in the process of carrying out a confirmatory trial of the regimen called APHINITY - a condition of accelerated approval under the FDA's priority review programme - and the committee seemed comfortable to accept the pCR measure in the interim with PFS data in the offing.

The FDA has been trying to secure approval quickly for new cancer therapies with potential to prevent cancer recurring in patients with early-stage disease. Herceptin was first approved for metastatic breast cancer in 1998 but did not have it use extended to early forms of the disease until eight years later.

Article by
Phil Taylor

13th September 2013

From: Research



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