The US Food and Drug Administration (FDA) has accepted GSK PLC's (LSE:GSK, NYSE:GSK) application to review the use of Blenrep (belantamab mafodotin) in treating relapsed or refractory multiple myeloma, a blood cancer.
If approved, Blenrep could be combined with bortezomib and dexamethasone (BorDex) or pomalidomide and dexamethasone (PomDex) for patients who have already undergone at least one prior therapy.
A final decision is expected by July 23 next year.
The application is supported by phase III trials, DREAMM-7 and DREAMM-8, which showed that Blenrep combinations significantly delayed disease progression compared to standard treatments.
The DREAMM-7 trial also demonstrated an improvement in overall survival rates, though results in DREAMM-8 are still being followed.
Multiple myeloma is the third most common blood cancer worldwide, with 180,000 cases diagnosed annually.
Despite being treatable, the disease often becomes resistant to current therapies, highlighting the need for new treatments.
Experts at GSK believe these results represent a major advancement, providing effective options with manageable side effects. Data from the trials, which include deeper and longer-lasting responses, will be shared at a medical conference in December.
This marks the sixth major regulatory submission for Blenrep this year across several countries.