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Home Industry News Roche receives FDA approval for breast cancer drug

Roche receives FDA approval for breast cancer drug

2nd October 2013

Roche has been granted approval for its pioneering pre-surgery breast cancer drug Perjeta from the US Food and Drug Administration (FDA).

The treatment, which is also known as pertuzumab, will be permitted for use as part of a complete treatment for patients prior to surgery. 

Perjeta received regulatory approval from the European Union in 2012 and has been used to treat patients with advanced or metastatic HER2-positive breast cancer.

These cancers have higher levels of HER2 protein, which boosts the growth of the cancerous cells and increases their survival. 

The drug has been granted accelerated approval through the FDA's priority review programme, but this is on the provision that Roche now conducts a confirmatory trial. More than 4,800 patients have already been enlisted and the results are expected in 2016.

Dr Hal Barron, chief medical officer and head of global product development at Roche, said: "A new approval pathway has made Perjeta available to people with HER2-positive early breast cancer several years earlier than previously possible. Together with the FDA, we've charted new territory."ADNFCR-8000103-ID-801645078-ADNFCR

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