GSK PLC said on Monday that the US Food & Drug Administration accepted a biologics license application for its Blenrep combinations for the treatment of relapsed and refractory multiple myeloma, both forms of bone marrow cancer.

GSK, the UK’s second-largest pharmaceutical firm, said the application covers the use of Blenrep in combination with BorDex and PomDex for patients with relapsed or refractory multiple myeloma who have undergone at least one prior line of therapy.

GSK said it expects a decision from the US regulator by July 23.

Multiple myeloma is the third most common type of blood cancer with more than 180,000 new cases diagnosed globally each year. More than 35,000 cases are expected to be diagnosed in 2024.

Although multiple myeloma is regarded as treatable, GSK said new therapies are needed as cases often become resistant to available treatments.

This marks the sixth major regulatory filing acceptance for Blenrep combinations in the treatment of relapsed and refractory multiple myeloma, following recent approvals in the UK and Europe.

Global Head Oncology, R&D, Hesham Abdullah said: ‘The US application is based on 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 shares were up 0.2% at 1,344.50 pence each in London on Monday morning.

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