Developer seeks FDA OK of treatment for hard-to-manage myeloma

The U.S. Food and Drug Administration (FDA) has set a date for next year by which it will decide whether or not to approve a combination regimen using the therapy candidate mezigdomide to treat hard-to-manage myeloma.

Bristol Myers Squibb (BMS), the company developing mezigdomide, announced in a company press release that the FDA has agreed to review its application seeking approval of the combo treatment. According to the developer, a decision by the regulatory agency is expected by May 13, 2027.

Regulators are also reviewing a separate application from BMS that seeks approval of iberdomide, another myeloma treatment candidate, the company had previously announced.

“The FDA’s acceptance of our application for mezigdomide highlights the continued momentum of our targeted protein degradation programs, as we now have two distinct agents under review in relapsed or refractory multiple myeloma, which remains a persistent disease,” said Cristian Massacesi, MD, executive vice president, chief medical officer, and head of development at BMS. Relapsed myeloma means the cancer returns after treatment, while refractory indicates that the condition has proven therapy-resistant.

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Myeloma is a form of blood cancer in which immune cells called plasma cells grow out of control in the bone marrow, the soft, spongy tissue found in the hollow centers of bones.

Treatment aims to kill myeloma cells

Mezigdomide and iberdomide both belong to a novel class of medications known as CELMoDs (Cereblon E3 Ligase Modulators), which aim to kill myeloma cells by targeting a protein called cereblon.

“We’re rapidly progressing the development of our CELMoD pipeline and are committed to leveraging this platform to bring the next wave of advances for patients in both hematologic malignancies and solid tumors,” Massacesi said.

BMS’s new application specifically seeks approval of mezigdomide in combination with two approved myeloma treatments: Kyprolis (carfilzomib) and dexamethasone, a combo known as MeziKd.

The developer is specifically asking the FDA to approve this combo for relapsed or refractory myeloma.

The new application is based mainly on data from a late-stage clinical trial called SUCCESSOR-2 (NCT05552976). The global Phase 3 study enrolled nearly 500 people with relapsed or refractory myeloma at more than 200 sites. The participants were randomly assigned to receive the MeziKd combo, or Kyprolis and dexamethasone without mezigdomide.

The results showed the MeziKd combo significantly slowed disease progression. Specifically, median progression-free survival — the time patients remain alive without their cancer worsening — was 18 months with MeziKd and 8.3 months with standard therapy. That works out to a 52% decrease in the risk of disease progression or death with MeziKd.

Safety data for the MeziKd were consistent with the known profiles of each of the three therapies used, according to researchers.