GSK: FDA' ODAC Votes In Favour Of Positive Benefit/risk Profile For Belantamab Mafodotin

(RTTNews) - GlaxoSmithKline plc (GSK, GSK.L) announced that the U.S. FDA Oncologic Drugs Advisory Committee has voted 12-0 in favour of positive benefit/risk profile for belantamab mafodotin for patients with relapsed/refractory multiple myeloma. Two committee members could not participate in the final vote.

The recommendation was based on review of DREAMM clinical trial programme, including the pivotal DREAMM-2 study.

The company said it looks forward to working with the FDA as they complete their review of Biologics License Application. The company added that, if approved, belantamab mafodotin will be a first-in-class anti-BCMA therapy for the treatment of relapsed/refractory multiple myeloma.

The FDA granted breakthrough therapy designation to belantamab mafodotin in 2017 and priority review designation for BLA earlier this year.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


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