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FDA gives green light to Roche for early Perjeta in breast cancer

Oncology drug can now be used before surgery in the US
Roche's Perjeta pertuzumab

The US Food and Drug Administration (FDA) has approved the use of Roche's oncology drug Perjeta for the treatment of people in the early stages of breast cancer.

The decision means that Roche can market Perjeta (pertuzumab) as the first medicine available for use before surgery in women with early-stage breast cancer who have increased levels of the HER2 protein and who are at high risk of having their cancer return or spread.

Perjeta is to be used in combination with Roche's Herceptin (trastuzumab) and other chemotherapy prior to surgery, and after surgery patients should continue to receive Herceptin to complete one year of treatment.

This expands the use of Perjeta beyond its current indication for the treatment of patients with advanced or metastatic HER2-positive breast cancer, which Roche won approval for in 2012.

Since then, Perjeta has become one of Roche's key oncology products, winning approval in Europe in 2013 and making 106m Swiss francs in the first half of this year.

The latest approval should see this growth trend continue as Roche banks on Perjeta and another new oncology drug, Kadcyla (trastuzumab emtansine), to lead the way in HER2-positive breast cancer and succeed the hugely successful Herceptin (trastuzumab) once its patents begin to expire in 2014.

Hopes are high for Perjeta's blockbuster potential, and the FDA decision on the drug in early breast cancer was made under a priority review programme, which speeds up the regulatory process for drugs that offer major advances in treatment.

The FDA also granted Perjeta accelerated approval status, which allows drugs for serious conditions to be approved using a 'surrogate' endpoint while confirmatory clinical trials are conducted after the drug reaches market.

Under this review process, Roche was able to use the pathologic complete response (pCR) – the absence of invasive cancer in the breast and lymph nodes - as an endpoint to support to the latest approval for Perjeta.

Results from the confirmatory trial are expected in 2016 and will provide further data on efficacy, safety and long-term outcomes.

“Together with the FDA, we've charted new territory,” commented Dr Hal Barron, chief medical officer at Roche. “A new approval pathway has made Perjeta available to people with HER2-positive early breast cancer several years earlier than previously possible.”

Roche also confirmed it was discussing the option of submitting Perjeta in the neoadjuvant setting in regions outside the US.

Article by
Thomas Meek

1st October 2013

From: Sales, Regulatory

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