U.S. FDA Approves Roche's Gazyva for Untreated Follicular Lymphoma

By Marc Bisbal Arias Features Dow Jones Newswires

Roche Holding AG (RO.EB) said Friday that the U.S. Food and Drug Administration approved Gazyva for previously untreated advanced follicular lymphoma, a form of blood cancer.

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The company said that the approval is based on results from a phase 3 study that showed superior progression-free survival for patients who received a Gazyva-based regimen when compared with standard therapy.

"We're pleased we can now offer...an initial treatment option shown to improve upon...the standard of care in this setting for more than 10 years," Roche's Chief Medical Officer Sandra Horning said.

Follicular lymphoma--the most common slow-growing form of non-Hodgkin lymphoma--is incurable and becomes harder to treat each time it returns, the company said. It is estimated that more than 75,000 people are diagnosed with it every year worldwide, Roche added.

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

(END) Dow Jones Newswires

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November 17, 2017 01:41 ET (06:41 GMT)