Roche: FDA grants priority review to lymphoma drug.
(CercleFinance.com) - US health regulators granted a priority review for Roche's follicular lymphoma drug Gazyva, potentially speeding up the monoclonal antibody's route to market with this indication.
The Food and Drug Administration (FDA) has accepted the company's supplemental biologics license application (sBLA) and granted priority review for Gazyva, in combination with chemotherapy, followed by Gazyva alone, for people with previously untreated follicular lymphoma, one of the most common blood cancers among adults.
A slow-growing form of non-Hodgkin lymphoma, follicular lymphoma is incurable and characterized by cycles of remission and relapse.
The FDA is expected to make a decision on its approval by the end of the year.
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