FDA review underway for combination therapy in multiple myeloma

The US Food and Drug Administration (FDA) has accepted a new application for Blenrep (belantamab mafodotin) in combination with other drugs to treat patients with relapsed or refractory multiple myeloma, a form of blood cancer. This treatment is being considered for patients who have already undergone at least one prior therapy. A decision is expected by July 23, 2025.

This application is supported by two large studies, DREAMM-7 and DREAMM-8, which showed that Blenrep combinations significantly improved outcomes like delaying disease progression and, in some cases, extending patients’ lives compared to standard treatments.

What makes this important?

Multiple myeloma is a challenging cancer to treat because it often becomes resistant to existing therapies. Blenrep, when paired with other drugs like bortezomib (BorDex) or pomalidomide (PomDex), may offer new hope by improving survival rates while remaining manageable in terms of side effects.

These new treatment combinations could change how we manage relapsed multiple myeloma, offering patients better outcomes and more accessible care.
— Hesham Abdullah, GSK’s global head of oncology research

The data behind the decision

The DREAMM-7 and DREAMM-8 trials tested Blenrep in combination with widely used cancer drugs. Key findings include:

• Improved survival: Patients lived longer and had better control over their disease compared to those on standard treatments.

• Deeper and longer-lasting responses: Patients had more durable improvements in their condition.

• Safety: Side effects were consistent with what doctors already know about these drugs, making the combinations predictable and manageable for patients.

In one of the studies, DREAMM-7, Blenrep showed a significant improvement in overall survival rates, a key measure of its effectiveness. These findings will be presented at a major cancer conference in December 2024.

Why this matters

Every year, over 35,000 people in the US are diagnosed with multiple myeloma. While treatments have improved in recent years, many patients eventually stop responding to available options. New therapies like Blenrep combinations could fill this gap, providing more effective solutions after the first signs of relapse.

If approved, this would mark the sixth major regulatory acceptance for Blenrep combinations in 2024 alone, reflecting growing global confidence in this approach. Regulatory reviews are also underway in Europe, Japan, Canada, and China, further highlighting its potential impact.

What’s next?

The FDA decision is expected in July 2025. In the meantime, GSK will continue working with regulators and presenting new data to demonstrate the value of this therapy. If successful, Blenrep combinations could become a game-changer in the fight against relapsed multiple myeloma.

For more information on Blenrep or multiple myeloma, visit GSK's official webpage.