GSK PLC on Tuesday said its Blenrep cancer treatment will undergo review in Japan after successful authorisations recently in the UK and Europe.
The London-based pharmaceutical company said Japan’s Ministry of Health, Labour and Welfare has accepted the application to review its Blenrep antibody drug in combination with BorDex or PomDex as a treatment for relapsed or refractory multiple myeloma, forms of bone marrow cancer.
Multiple myeloma is the third most common type of blood cancer with more than 180,000 new cases diagnosed globally each year, with Japan accounting for approximately 7,200 cases annually.
Although multiple myeloma is regarded as treatable, new therapies are needed as cases often become resistant to available treatments.
‘The application is based on interim results from the DREAMM-7 and DREAMM-8 phase III trials, which both met their primary endpoints, showing statistically significant and clinically meaningful improvements in progression-free survival,’ GSK said.
This is the third major regulatory filing acceptance for Blenrep combinations in the treatment of relapsed and refractory multiple myeloma, following the acceptance of marketing authorisation applications by the European Medicines Agency in July and the UK Medicines and Healthcare products Regulatory Agency earlier this month.
GSK shares were up 0.5% at 1,640.50 pence each in London on Tuesday morning.
Copyright 2024 Alliance News Ltd. All Rights Reserved.
