(Alliance News) - GlaxoSmithKline PLC on Friday said it has received a positive opinion from the European medicines regulator for blood cancer treatment Belantamab Mafodotin.
The Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion recommending the approval of Belantamab Mafodotin as a monotherapy for the treatment of multiple myeloma in adult patients, the London-based pharmaceutical company said.
Multiple myeloma is a cancer that forms in a type of white blood cell called a plasma cell.
Belantamab Mafodotin was granted Prime designation in 2017, and the conditional marketing authorisation application was reviewed under European Medicines Agency's accelerated assessment procedure.
The positive opinion is one of the final steps before marketing authorisation is granted by the European Commission.
If approved, Belantamab Mafodotin will be marketed as Blenrep, Glaxo said.
The conditional marketing authorisation application for Belantamab Mafodotin is based on data from the Driving Excellence in Approaches to Multiple Myeloma study including 13-month follow-up data.
The data demonstrated that treatment with single-agent Belantamab Mafodotin resulted in an overall response rate of 32%. Median duration of response was 11 months and median overall survival was 13.7 months.
Belantamab Mafodotin is also under review by the US Food & Drug Administration which granted a priority review for the company's Biologics License Application.
Shares in Glaxo were down 1.9% at 1,577.20 pence each in London on Friday afternoon.
By Tapan Panchal; tapanpanchal@alliancenews.com
Copyright 2020 Alliance News Limited. All Rights Reserved.
Glaxosmithkline (GSK)