UK-based pharmaceutical company GSK announced that the US Food and Drug Administration (FDA) has accepted its application to obtain a new indication for Nucala.
Nucala (mepolizumab) is a monoclonal antibody that targets and binds to interleukin-5 (IL-5), a key messenger protein (cytokine) in type 2 inflammation.
It is already approved in the US, for Eosinophilic granulomatosis with polyangiitis (EGPA), Hypereosinophilic syndrome (HES), and Chronic rhinosinusitis with nasal polyps (CRSwNP).
Currently, GSK seeks FDA approval for Nucala as an add-on maintenance treatment for patients with chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype.
The US health agency fixed 7 May 2025 as Prescription Drug User Fee Act (PDUFA) date.
The British drugmaker’s submission is based on data from the MATINEE study, which assessed the efficacy and safety of Nucala in 804 COPD patients with type 2 inflammation.
The study met its primary endpoint, achieving a statistically significant and clinically meaningful reduction in the annualised rate of exacerbations versus placebo.
In a separate development, GSK announced positive results for evaluating Blenrep (belantamab mafodotin) in combination with bortezomib plus dexamethasone (BVd).
The announcement is based on results from a planned interim analysis of the DREAMM-7, a randomised, multicentre, open-label, Phase 3 clinical trial.
In the Phase 3 study, the Blenrep combination was compared with daratumumab plus bortezomib plus dexamethasone (DVd), for relapsed or refractory multiple myeloma.
The regimen showed statistically significant and clinically meaningful overall survival (OS) results and improvement in progression-free survival (PFS).
GSK R&D oncology global head and senior vice president Hesham Abdullah said: “The compelling overall survival data from the DREAMM-7 trial establish the potential of Blenrep in combination to significantly extend the lives of patients with multiple myeloma at or after first relapse.
“This represents an important advancement that could redefine the treatment of relapsed or refractory multiple myeloma.”
China’s National Medical Products Administration (NMPA) has accepted GSK’s new drug application (NDA) for Blenrep plus BVd to treat relapsed or refractory multiple myeloma.
The announcement follows NMPA’s priority review and Breakthrough Therapy Designation for BVd combination, granted earlier this year.
Hesham added: “Today’s regulatory filing acceptance, with a priority review, is a meaningful step forward in our efforts to bring the benefits of Blenrep in combination to patients in China.
“Multiple myeloma patients need new options that may improve outcomes, particularly at first relapse. The DREAMM-7 trial shows statistically significant efficacy, including overall survival and could redefine treatment in this patient population.”
