FDA Grants Priority Review to Roche’s Glofitamab BLA in Large B-Cell Lymphoma

The FDA has granted priority review to Roche’s biologics license application (BLA) for glofitamab for the treatment of adults with relapsed or resistant large B-cell lymphoma after two or more lines of systemic therapy.

The BLA is supported by data from a phase 1/2 study, which showed that participants taking glofitamab achieved a complete response of 40 percent, with 73.1 percent of those who had a complete response still experiencing a response at 12 months.

“Even for patients whose cancer is rapidly progressing, glofitamab given for a fixed duration has shown impressive efficacy and long-term durability, with patients continuing to experience a complete remission after treatment has concluded,” said Levi Garraway, Roche’s head of global product development.

The expected FDA decision date for the immunotherapy candidate is July 1.