FDA Votes Against Proposed Blenrep Treatment Combo’s for Multiple Myeloma

The FDA's Oncologic Drugs Advisory Committee has casted their votes on the utilization of certain treatments in the multiple myeloma patient population.

The U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) has casted their votes on the utilization of certain treatments in the multiple myeloma patient population, according to information shared from the ODAC during a regulatory meeting.

According to the official U.S. FDA website, the ODAC is an expert panel made up of 13 individuals who evaluate clinical data on the safety and effectiveness of both approved and investigational cancer therapies. Based on the panels review, the committee offers recommendations to the FDA Commissioner to support regulatory decision-making.

Committee members are chosen for their expertise in areas such as general oncology, pediatric oncology, hematologic and immunologic oncology, biostatistics, and related fields. The committee may also include a non-voting industry representative who offers insights from the pharmaceutical sector but does not take part in voting.

For adult patients with relapsed/refractory multiple myeloma who have received at least one prior line of therapy, the ODAC voted five to three against the risk/benefit profile for the new proposed dosage of Blenrep (belantamab mafodotin) plus Velcade (bortezomib) and dexamethasone (also referred to as BVd).

Moreover, the committee voted seven to one against the risk/benefit profile of the new proposed dosage of Blenrep plus pomalidomide (Pomalyst) and dexamethasone (also referred to as BPd) for the same patient population.

ODAC’s Vote on the Risk/Benefit Profile of Blenrep Combo’s in Myeloma

The FDA voted against approving both the BVd and BPd combinations for patients with previously treated, relapsed/refractory multiple myeloma due to concern that the benefits of the treatment combinations at their proposed dosages did not outweigh the treatment risks.

Notably, the committee cited the high rate of eye-related side effects (ocular toxicity) as cause for concern. High rates of vision problems, such as blurry vision and corneal damage, were seen in up to 93% of patients; many patients needed dose delays or reductions, and some discontinued treatment. Moreover, vision changes often lasted weeks or months, and some still had unresolved eye issues at the time of review.

The FDA committee also noted that they are unsure if the correct dose was chosen. If a less aggressive dosing option was utilized, this may have reduced side effects; however, this was never fully explored. Another cause for concern for the regulatory agency was that most trial participants were not from the U.S., and key populations were underrepresented, such as older adults and black patients. Therefore, the agency things that this made it unclear how results apply to real-world U.S. patients.

“This was a challenging decision because the efficacy data were strong, but the toxicity data were also very strong… We've heard impassioned testimonials from key opinion leaders and from many researchers in the myeloma community. All of the building blocks are here to explore this question in the future, from patients to researchers to physicians,” Dr. Neil Vasan, a medical oncologist at NYU Langone, explained on why he voted against both drug combinations.

However, it is important to understand that both treatment combinations improved progression-free survival in the phase 3 DREAMM-7 and DREAMM-8 studies. Notably, in November of 2024, the FDA even accepted a biologics license application for review which was seeking the approval of BVd and BPd for patients with relapsed/refractory multiple myeloma, based on data from the two clinical trials. This application came just a few weeks prior to positive updated data being read out at the 2024 ASH Annual Meeting and Exposition.

Despite the improved survival data strong anti-myeloma activity with the Blenrep combinations, the ODAC was not convinced that Blenrep at the proposed dosages were safe or well-tolerated.

Reference

1. Meeting of the Oncologic Drugs Advisory Committee (ODAC). FDA. Accessed July 17, 2025. https://www.youtube.com/live/CLhBI3UXWyg

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