Roche Granted FDA Priority Review for Blood Cancer Treatment

By FeaturesDow Jones Newswires

Roche Holding AG (ROG.EB) on Monday said the U.S. Food and Drug Administration has granted priority review to its treatment for follicular lymphoma, one of the most common blood cancers among adults.

The FDA gave the treatment, Gazyva, priority after seeing positive results in phase III clinical trials and is expected to make a decision on approval by Dec. 23.

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The treatment consists of an antibody that works with the immune system to attack cancerous cells. It is aimed at people with untreated follicular lymphoma, Roche said, adding that the cancer is considered incurable.

Trial results showed that Gazyva-based treatment significantly lengthened the time between relapses when compared with the current standard of care and also reduced the risk of the disease worsening or causing death.

It is estimated that every year, more than 75,000 people worldwide are diagnosed with follicular lymphoma, Roche said, adding that relapses are common.

Write to Marc Bisbal Arias at marc.bisbalarias@dowjones.com

(END) Dow Jones Newswires

August 28, 2017 04:58 ET (08:58 GMT)