19th Jun 2020 15:58
(Alliance News) - GlaxoSmithKline PLC on Friday said a US regulator is convening committee meeting to review data on the drugmaker's application for belantamab mafodotin in relapsed or refractory multiple myeloma.
The US Food & Drug Administration is to convene a virtual meeting of the Oncologic Drugs Advisory Committee in order to review data supporting Glaxo's biologics licence application for the drug in relapsed or refractory multiple myeloma patients who have already received four previous therapies.
Multiple myeloma is currently generally considered to be treatable but not curable and often becomes refractory to available treatments. It is the second most common blood cancer in the US.
The meeting will take place on July 14. Belantamab mafodotin was already given a breakthrough therapy designation in 2017 and the biologics licence application was given priority review status by the FDA in January based on data from Glaxo's Dreamm-2 study.
Shares in Glaxo were up 0.4% at 1,654.20 pence in London on Friday afternoon.
By Anna Farley; [email protected]
Copyright 2020 Alliance News Limited. All Rights Reserved.
Related Shares:
Glaxosmithkline