GSK (GSK) said Monday that Japan's Ministry of Health, Labor and Welfare approved Blenrep combinations for adults with relapsed or refractory multiple myeloma.
The company said the decision was based on results from two phase 3 trials that evaluated Blenrep with bortezomib plus dexamethasone and Blenrep combined with pomalidomide plus dexamethasone in multiple myeloma patients who have received at least one prior therapy.
The studies showed statistically significant and clinically meaningful improvements in progression-free survival compared with standard treatments, GSK said. The trial evaluating Blenrep combined with bortezomib plus dexamethasone also showed significant improvement in overall survival, GSK said.
Blenrep combinations for multiple myeloma were approved in the UK last month and are under review in other major markets, including the US, where a decision is expected by July 23, the company said.
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