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FDA Grants Frontline Obinutuzumab Priority Review for Follicular Lymphoma

Jason Harris
Published: Monday, Aug 28, 2017

Dr. Sandra Horning

Sandra Horning, MD
The FDA has granted a priority review to a supplemental biologics license application (sBLA) for obinutuzumab (Gazyva) in combination with chemotherapy, followed by obinutuzumab alone, for the first-line treatment of patients with follicular lymphoma, according to Genentech, the manufacturer of the therapy.

The FDA previously approved obinutuzumab for use in combination with bendamustine for patients with follicular lymphoma who have received prior therapy.

References

  1. FDA Grants Priority Review for Genentech’s Gazyva in Previously Untreated Follicular Lymphoma. Available at: https://www.gene.com/media/press-releases/14678/2017-08-27/fda-grants-priority-review-for-genentech. Posted August 27, 2017. Accessed August 27, 2017.
  2. Shah, NN, Stetler-Stevenson M, Yuan CM, et al. Minimal residual disease negative complete remissions following anti-CD22 chimeric antigen receptor (CAR) in children and young adults with relapsed/refractory acute lymphoblastic leukemia (ALL). Presented at: 58th ASH Annual Meeting and Exposition; San Diego, California; December 2-6, 2016. Abstract 650.

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