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Roche's blood cancer antibody wins priority review in US

Obinutuzumab is fast-tracked by FDA in treatment of chronic lymphocytic leukaemia

Roche Basel Switzerland

Roche today announced that its investigational blood cancer antibody obinutuzumab will undergo a fast-tracked regulatory process in the US under the Food and Drug Administration's (FDA) priority review programme.

It is the second FDA priority review for a Roche product announced this week, following the news that Perjeta (pertuzumab) will face a similar regulatory pathway for use before surgery (neoadjuvant treatment) in women with HER2-positive breast cancer.

The priority review for obinutuzumab covers the antibody's use in the treatment of chronic lymphocytic leukaemia, one of the most common forms of blood cancer, which is thought to cause the deaths of nearly 5,000 people each year in the US.

The designation can cut months off the approval time for new medicines, and Roche said an FDA decision is expected by the end of 2013.

Obinutuzumab – formerly known as GA101 – has shown great promise in early-stage trials, outperforming the company's Mabthera/ Rituxan (rituximab) in a head-to-head study in patients with non-Hodgkin's lymphoma (NHL).

The drug's success is especially important considering that Mabthera is set to lose patent exclusivity in 2015, leaving it open to generic competition.

Roche has also boosted its efforts in the diagnosis of blood disorders, such as leukaemia, with the purchase of Constitution Medical Investors and its 'Bloodhound' technology to provide fast, accurate analysis of blood.

The FDA seems to have as much hope for obinutuzumab as Roche does, and the priority review designation follows a previous 'breakthrough therapy' designation assigned to the drug in May 2013.

This breakthrough therapy designation is a relatively new FDA label for medicines intended to treat serious and life-threatening diseases, and is designed to speed up the development and review process by providing intensive FDA guidance on an efficient drug development programme.

“These FDA designations acknowledge the promising trial results with GA101 and will hopefully allow this novel medicine to reach the people who need it in an expedited time frame,” said Dr Hal Barron, chief medical office of Roche.

Obinutuzumab is also under review in the Europe after Roche submitted a marketing application in April 2013.

3rd July 2013

From: Sales

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