Basel, Switzerland-based Roche (ROG: SIX) has been granted priority review status for its bid to broaden the label for blood cancer drug Gazyva (obinutuzumab) in the USA.
Roche has applied to extend the marketable use of the drug to include treatment in combination with chemotherapy, followed by Gazyva as a monotherapy, for people with previously untreated follicular lymphoma.
The application is supported by Phase III data comparing treatment with Rituxan (rituximab), the current standard of care. The company says the results show superior progression-free survival for its therapy.
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