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Roche's Gazyva Approved in the U.S.

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Roche (RHHBY - Free Report) is a leader in oncology drugs with strong demand for breast cancer drugs like Herceptin, Perjeta and Kadcyla.

Apart from making efforts to develop its breast cancer franchise, Roche is also keen to develop drugs for other indications. One of the leading drugs in Roche’s portfolio is MabThera (branded as Rituxan in the U.S.) which is indicated for blood cancers like non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukemia (CLL).

Roche received positive news when the U.S. Food and Drug Administration (FDA) approved another drug, Gazyva (obinutuzumab), for the treatment of CLL.

The approval was based on positive results from the CLL11 trial wherein it was observed that Gazyva in combination with chlorambucil chemotherapy led to a significant reduction in the risk of disease progression or death. Moreover, it also improved the life span of patients without their disease getting worse as compared to chlorambucil alone.

Roche will present final data from the CLL11 trial in Dec 2013. The trial is evaluating Gazyva in combination with chlorambucil and MabThera/Rituxan in combination with chlorambucil.

We note that the FDA granted ‘Breakthrough Therapy Designation’ to Gazyva in May 2013 following the release of positive data from the CLL11 trial.

The successful commercialization of Gazyva would help Roche replace revenues that may be lost to biosimilar versions of Rituxan once they enter the market.

We note that companies like Amgen (AMGN - Free Report) are working on biosimilar versions of Rituxan.

Rituxan is approved for the treatment of CLL. Rituxan was one of the best selling drugs for Roche in the first nine months of 2013 with sales of CHF 5.2 billion, up 6% year over year.

We remind investors that Roche has another pipeline candidate, RG7601, which is being developed for the treatment of relapsed/refractory (R/R) CLL and R/R non-Hodgkin lymphoma (NHL) in collaboration with AbbVie (ABBV - Free Report) .

Roche currently carries a Zacks Rank #3 (Hold). Right now, Novo Nordisk (NVO - Free Report) looks attractive with a Zacks Rank #2 (Buy). 

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