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Genentech Says FDA Grants Priority Review For Gazyva

Genentech, a member of the Roche Group (RHHBY), said that the U.S. Food and Drug Administration has accepted the company's supplemental Biologics License Application or sBLA and granted Priority Review for Gazyva or obinutuzumab in combination with chemotherapy followed by Gazyva alone for people with previously untreated follicular lymphoma, one of the most common blood cancers among adults.

Follicular lymphoma, a slow-growing (indolent) form of non-Hodgkin's lymphoma, is incurable and characterized by cycles of remission and relapse.

The sBLA is based on results of the GALLIUM study, which is the first Phase III study in previously untreated follicular lymphoma to show superior progression-free survival over Rituxan (rituximab)-based treatment, the current standard of care. Adverse events (AEs) with either Gazyva or Rituxan were consistent with those seen in previous studies.

The FDA is expected to make a decision on approval under Priority Review by December 23, 2017.

Priority Review designation is granted to medicines that the FDA has determined to have the potential to provide significant improvements in the safety and effectiveness of the treatment, prevention or diagnosis of a serious disease. Additional submissions of the GALLIUM data to health authorities around the world are ongoing.

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