GSK Gets CHMP Nod for Blenrep Combos in Multiple Myeloma

The European Medicines Agency's CHMP issued a positive opinion recommending approval of GSK's Blenrep combination therapy for relapsed or refractory multiple myeloma, based on Phase III DREAMM-7 and DREAMM-8 data showing statistically significant improvements in progression-free and overall survival; the European Commission is expected to make a final decision in Q3 2025. This follows Blenrep's prior withdrawal from the US and EU markets in 2022 after a failed confirmatory study, and recent approvals of the Blenrep combo in the UK and Japan, with a US FDA decision anticipated on July 23, 2025.

Analysis

GSK plc has received a significant regulatory endorsement from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), which issued a positive opinion recommending approval for Blenrep (belantamab mafodotin) combination therapies for relapsed or refractory multiple myeloma. This recommendation is supported by data from the Phase III DREAMM-7 and DREAMM-8 studies, which demonstrated statistically significant and clinically meaningful improvements in progression-free survival (PFS) and overall survival for patients who had received at least one prior therapy. The European Commission is expected to deliver a final decision in the third quarter of 2025. This development marks a potential comeback for Blenrep, which was withdrawn as a monotherapy from the U.S. market in November 2022 and subsequently from the EU market following the failure of the DREAMM-3 confirmatory study. The Blenrep combination therapies have already secured approval in the United Kingdom (April 2025) and Japan (May 2025), with a U.S. FDA decision anticipated by July 23, 2025, and reviews ongoing in other key markets including China, Canada, and Switzerland. GSK's stock has reflected positive sentiment, rallying 14.3% year-to-date, contrasting with the industry's 5.5% decline, indicating investor confidence in the drug's revised prospects and GSK's broader pipeline.

Key Decisions for Investors

• Investors should closely monitor the upcoming U.S. FDA decision on Blenrep combination therapy by July 23, 2025, and the European Commission's final decision in Q3 2025, as these are critical catalysts for GSK's oncology franchise and future revenue streams from Blenrep.
• Considering GSK's strong year-to-date stock performance of +14.3% driven by positive news flow including the CHMP opinion, investors may evaluate the current valuation in anticipation of these regulatory milestones, which could further de-risk the asset and unlock value.
• It is important to assess the competitive environment in the multiple myeloma space and how the re-introduction of Blenrep, now as a combination therapy with improved efficacy data, could impact market share and GSK's long-term growth trajectory in oncology.