Updated 7/23/2025
The FDA has announced a delay in its decision on Blenrep (belantamab mafodotin), signaling that more time is needed to complete its review. The deadline for approval is October 23, 2025.
The MMRF remains hopeful and continues to support approval of this therapy, which we believe offers important clinical benefits and addresses real access challenges for patients with relapsed/refractory multiple myeloma.
While we await further updates, here’s why the MMRF sees Blenrep as a valuable and potentially transformative option for the myeloma community.
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Blenrep specifically targets BCMA, a protein found on myeloma cells, and delivers chemotherapy directly to the cells. One of the most promising aspects of Blenrep is its effectiveness in clinical trials, especially for patients who had only one prior line of therapy. When combined with Velcade (bortezomib) and dexamethasone, Blenrep helped patients live longer without their disease progressing. It also increased overall survival.
Another key benefit? Access.
Unlike CAR T-cell therapy, which is also effective but harder to get, Blenrep is “off the shelf.” It is administered through a 30-minute, IV infusion that can be given in community oncology centers without the need to travel to a major academic hospital. For many, this could be a big step forward in health equity, especially for patients in rural or underserved areas.
Two Big Questions, Two Tough Calls
In a recent meeting, the FDA’s Oncology Drug Advisory Committee (ODAC) reviewed two new combinations involving Blenrep:
1. Blenrep + Velcade + dexamethasone (BVd)
2. Blenrep + Pomalyst (pomalidomide) + dexamethasone (BPd)
The ODAC was asked whether the benefits of these combinations outweigh the risks for patients who have already had at least one prior treatment. After reviewing the evidence, the committee voted 5 to 3 against the BVd combination and 7 to 1 against the BPd combination.
Does Dosing Make a Difference?
We know from earlier studies that Blenrep can cause eye-related side effects. But during the ODAC meeting, the biggest concern was the dose of Blenrep used in the most recent clinical trials. Many experts felt the dose was higher than necessary.
This challenge isn’t unique to Blenrep. In cancer treatment, there’s often a difficult balance between giving enough medication to fight the disease and keeping side effects under control. Sometimes, by the time a drug is ready for approval, the dose may not be fully optimized yet, but the benefits are strong enough to justify moving forward. That’s where programs like the MMRF’s Horizon platform come in. The MMRF is working to optimize dosing strategies for promising therapies like Blenrep—especially in patient groups that have often been left out of trials in myeloma, such as older adults and African Americans. These efforts help ensure the treatments are both effective and tolerable for a broader range of patients. With programs like Horizon in place to continue optimizing care, there’s even more reason to consider Blenrep a valuable option for the myeloma community.
The Patient Voice for Blenrep
In addition to Anne Quinn Young, Chief Mission Officer at the MMRF, as well as leaders from Healthtree and the IMF, several patients who are currently being treated with Blenrep spoke during the open testimony portion of the meeting. Uniformly, each offered stories of hope and gratitude, with most sharing that they had few or no other treatment options. Alternatives were often unavailable, not covered by insurance, or came with side effects they found more difficult to manage.
Patients appreciated that Blenrep was effective for them and that the treatment was easy to receive, requiring only a short 30-minute infusion. For many, the vision-related side effects were manageable with the use of eye drops, sunglasses, or reading glasses—tools they felt were a reasonable trade-off for the side effects experienced.
The Clinician’s Case for Blenrep
Doctors also acknowledged that eye-related side effects are real, but they stressed that these issues are predictable, reversible, and manageable. With regular check-ins and teamwork between oncologists and eye doctors, many patients can stay on treatment safely. Some providers also discussed how adjusting doses can reduce side effects without affecting how well the drug works. With these strategies and the right support, many doctors believe Blenrep could still be a valuable option for patients who need it.
What Happens Next and What this Means for You
While ODAC’s vote is influential, it is not the final decision. While the MMRF supports the FDA approval of Blenrep, the ODAC discussion sends an important message to the myeloma community regardless of approval status: It’s more important than ever to have open conversations with your care team about what treatments are available, what risks they carry, and how they fit into your specific situation.
Here are a few tips to help guide those conversations around shared-decision making:
· Ask your doctor what side effects you might expect and how to manage them.
· Talk about your treatment goals.
· Bring up your lifestyle and daily routines. Let your care team know what matters most to you.
· Ask if there are other treatment options through clinical trials.
Knowing what’s realistic and within reach can help shape next steps. Remember: You don’t have to make these decisions alone. The MMRF Patient Navigation Center is here to support you with one-on-one guidance, resources, and information tailored to your needs.
