• 26 May 2025
• Admin
• News Article

GSK’s Blenrep Receives CHMP Recommendation for Use in Relapsed or Refractory Multiple Myeloma

London, UK – GSK plc announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Blenrep for:

• Use in adults with relapsed or refractory multiple myeloma
• In combination with:
  • Bortezomib + dexamethasone (BVd) for patients with at least one prior therapy
  • Pomalidomide + dexamethasone (BPd) for patients previously treated with lenalidomide

An approval decision by the European Commission is expected in Q3 2025.

Global Regulatory Momentum

This CHMP opinion follows recent approvals:

• UK MHRA: April 2025
• Japan's Ministry of Health, Labour and Welfare: May 2025

Backed by Strong Phase III Trial Data

Both DREAMM-7 and DREAMM-8 trials showed:

• Statistically significant and clinically meaningful progression-free survival (PFS)
• Overall survival (OS) benefit in DREAMM-7
• Safety profiles consistent with individual agents

GSK Commentary

“Today’s positive CHMP opinion is an important milestone toward bringing the benefits of Blenrep combinations to patients in Europe,”
— Hesham Abdullah, SVP, Global Head Oncology R&D, GSK

Key Advantages:

• Well-positioned to meet unmet patient needs
• Administered in-office, suitable for both academic and community settings
• No complex pre-administration or hospitalisation required

Disease Background

• ~50,000 new cases of multiple myeloma per year in Europe
• Most patients relapse after initial treatment
• Blenrep is the only anti-BCMA antibody-drug conjugate (ADC) available
• Suitable for treatment across different settings and patient types

Safety & Tolerability

Eye-related side effects:

• Reversible with dose modifications
• Low discontinuation rates (≤9%)

Most common non-ocular adverse events:

DREAMM-7:

• Thrombocytopenia (87%)
• Diarrhoea (32%)

DREAMM-8:

• Neutropenia (63%)
• Thrombocytopenia (55%)
• COVID-19 (37%)

Global Submissions Underway

Under review in major markets including:

• USA: PDUFA date – 23 July 2025
• China: With Breakthrough Therapy Designation & priority review
• Canada
• Switzerland

About the Clinical Trials

DREAMM-7 Overview

Design: Randomised Phase III
Participants: 494 patients
Comparison: BVd (Blenrep + bortezomib + dexamethasone) vs DVd (daratumumab + bortezomib + dexamethasone)

Key Results:

1. PFS: 36.6 months (BVd) vs 13.4 months (DVd)
   • HR: 0.41 | 95% CI: 0.31–0.53 | p < 0.00001
2. OS: 42% reduction in risk of death
   • HR: 0.58 | 95% CI: 0.43–0.79 | p = 0.00023
   • 3-year OS rate: 74% (BVd) vs 60% (DVd)

Published In:

• New England Journal of Medicine
• Presented at ASCO and ASH 2024

DREAMM-8 Overview

Design: Randomised Phase III
Participants: 302 patients
Comparison: BPd (Blenrep + pomalidomide + dexamethasone) vs PVd (bortezomib + pomalidomide + dexamethasone)

Key Results:

1. PFS: Not reached (BPd) vs 12.7 months (PVd)
   • HR: 0.52 | 95% CI: 0.37–0.73 | p < 0.001
2. 1-year PFS rate:
   • 71% (BPd) vs 51% (PVd)
3. OS: Positive trend (HR: 0.77), not yet statistically significant

Subgroups showing benefit:

• Lenalidomide-refractory patients
• Patients with high-risk cytogenetics

Published In:

• New England Journal of Medicine
• Presented at ASCO 2024

About Blenrep

Composition:

• ADC composed of humanised anti-BCMA monoclonal antibody + auristatin F
• Linked via a non-cleavable linker

Technology Partners:

• Drug linker tech: Seagen Inc.
• Monoclonal antibody tech: BioWa Inc. (Kyowa Kirin Group)

Approved Indications in the UK:

• With BVd in patients after ≥1 therapy
• With BPd in patients after ≥1 therapy including lenalidomide