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GlaxoSmithKline myeloma treatment gets nod from FDA committee

By Josh White

Date: Wednesday 15 Jul 2020

GlaxoSmithKline myeloma treatment gets nod from FDA committee

(Sharecast News) - GlaxoSmithKline announced on Wednesday that the oncologic drugs advisory committee of the US Food and Drug Administration (FDA) has voted in favour of "the demonstrated benefit" of monotherapy treatment with 'belantamab mafodotin'.

The FTSE 100 pharmaceuticals giant said the committee believed the benefit outweighed the risks for patients with relapsed or refractory multiple myeloma, who received at least four prior therapies including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.

It noted that two committee members could not participate in the final vote.

The recommendation was based on data from the 'DREAMM' clinical trial programme, including the pivotal 'DREAMM-2' study, which enrolled "heavily pretreated" patients who had actively progressing multiple myeloma that had worsened despite current standard of care.

It said the six-month primary results from the study were published in the Lancet Oncology in December, and served as the basis for the biologics license application.

The FDA would consider the recommendation of the committee, but was not obliged to follow it.

GSK said the FDA granted 'breakthrough therapy designation' to belantamab mafodotin in 2017, and priority review designation for the biologics license application earlier in the year.

A marketing authorisation application for belantamab mafodotin was also under accelerated assessment by the European Medicines Agency.

Belantamab mafodotin is not currently approved for use anywhere in the world, the company confirmed.

"We are pleased the committee recognised the potential for belantamab mafodotin to help patients who have relapsed or refractory multiple myeloma, an incurable disease with limited treatment options," said senior vice-president and head of oncology research and development Dr Axel Hoos.

"We look forward to working with the FDA as they complete their review of our biologics license application."

At 0811 BST, shares in GlaxoSmithKline were up 1.21% at 1,624.20p.

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