Roche Holding AG (RHHBY) announced positive results from a phase III study, GADOLIN, on leukemia drug Gazyva.
The study evaluated treatment options for patients suffering from indolent non-Hodgkin’s lymphoma (iNHL) who are refractory to Rituxan.
The study showed patients surviving significantly longer without their disease worsening or death when treated with Gazyva plus Treanda followed by only Gazyva when compared to only Treanda.
An independent data monitoring committee determined that the study met its primary endpoint of progression-free survival during a pre-planned interim analysis. Consequently, the study was stopped before its protocol-specified final analysis.
Gazyva generated sales of CHF49 million in 2014. We remind investors that Gazyva was approved by the FDA for use in combination with chlorambucil in people with previously untreated chronic lymphocytic leukemia on Nov 1, 2013 under Breakthrough Therapy designation. The drug was approved for the same indication by the European Commission in Jul 2014 under the brand name Gazyvaro.
Initial uptake of the drug was positive in Europe, while competition and limited use of chlorambucil negatively impacted its uptake in the U.S.
In Dec 2014, the FDA approved a supplemental biologics license application expanding Gazyva's label to include data that showed significant improvements of Gazyva plus chlorambucil over MabThera/Rituxan plus chlorambucil.
Roche’s efforts to expand Gazyva’s label for iNHL will boost its sales further.
Roche currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the broader health care sector include Allergan (AGN), Biodel Inc. (BIOD) and Sucampo Pharmaceuticals (SCMP). While Biodel and Sucampo carry a Zacks Rank #1 (Strong Buy), Allergan is a Zacks Rank #2 (Buy) stock.
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