Roche (RHHBY) announced that the FDA has approved a supplemental biologics license application (sBLA) for its blood cancer drug, Gazyva in combination with chlorambucil chemotherapy in patients suffering from treatment-naïve chronic lymphocytic leukemia (CLL).
The approval of the sBLA adds positive data from stage II of the CLL11 study to its label, wherein it was observed that Gazyva plus chlorambucil showed significant improvement across multiple clinical endpoints when compared head-to-head with Rituxan plus chlorambucil.
The approval also came on the complete response and minimal residual disease data from the above mentioned study along with overall survival data from stage I of the study, which compared Gazyva plus chlorambucil to chlorambucil alone and Rituxan plus chlorambucil to chlorambucil alone.
We remind investors that Gazyva had been approved by the FDA for use in combination with chlorambucil for previously untreated CLL on Nov 1, 2013 under its Breakthrough Therapy designation.
The drug was also approved for the same indication by the European Commission in Jul 2014 under the brand name Gazyvaro.
Gazyva generated sales of $32 million in the first nine months of 2014. Roche is evaluating Gazyva for various types of blood cancers such as non-Hodgkin’s lymphoma, which is currently in multiple phase III studies for the same indication.
We are encouraged by Roche’s performance so far in 2014. The oncology portfolio looks solid as ever and we expect further traction. We are also impressed by the company's efforts to grow its portfolio beyond oncology to immunology and ophthalmology. However, generic competition for Xeloda and Pegasys will negatively impact sales in the coming quarters.
Roche currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the broader health care sector include AbbVie (ABBV), Allergan (AGN) and Biodel Inc. (BIOD). While Biodel carries a Zacks Rank #1 (Strong Buy), the other two carry a Zacks Rank #2 (Buy).
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