FDA reviewing new iberdomide combo for hard-to-treat multiple myeloma
Bristol Myers Squibb seeking approval after MRD results in Phase 3 study
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The U.S. Food and Drug Administration (FDA) is reviewing an application from Bristol Myers Squibb (BMS) seeking approval of its investigational oral therapy iberdomide for the treatment of people with hard-to-manage multiple myeloma.
The application seeks approval of iberdomide in combination with two standard myeloma therapies, Darzalex (daratumumab) and dexamethasone, for people with relapsed or refractory multiple myeloma (RRMM) — a form of the disease that has returned or stopped responding to prior treatment.
The FDA has granted the application priority review, which shortens the standard review timeline from about 10 months to about 6 months. The agency has set a target action date of Aug. 17, according to BMS.
FDA grants priority review for iberdomide filing
“The FDA’s acceptance of this application is a testament to the potential of iberdomide, in combination with [Darzalex and dexamethasone] as a novel, potent, oral treatment option, with a manageable safety profile, for patients with multiple myeloma,” Cristian Massacesi, MD, executive vice president and chief medical officer at BMS, said in a company press release.
Myeloma is a type of blood cancer in which plasma cells, immune cells found in the bone marrow, grow out of control. Because the disease often affects multiple areas of the bone, it is called multiple myeloma. Iberdomide belongs to a novel class of anticancer therapies known as cereblon E3 ligase modulators (CELMoDs). These medicines are designed to help break down proteins that cancer cells need to survive.
BMS’s application is based on data from the ongoing Phase 3 EXCALIBER-RRMM (NCT04975997) clinical trial. The trial enrolled more than 800 people with myeloma who had relapsed or refractory disease following one or two prior lines of treatment. Participants are treated with Darzalex and dexamethasone either in combination with iberdomide or the approved myeloma therapy bortezomib (sold as Velcade and generics).
Phase 3 trial targets MRD and disease progression
The study’s dual primary goals include measuring rates of minimal residual disease (MRD) negativity and progression-free survival, which tracks how long patients live without their disease worsening. MRD negativity means that highly sensitive tests cannot detect cancer cells, although it does not necessarily mean all cancer cells are gone. Earlier this year, BMS announced that a planned analysis showed significantly better MRD negativity rates with iberdomide compared with bortezomib. The study remains ongoing to evaluate additional outcomes, including overall survival.
“Our filing for iberdomide based on the MRD endpoint, underscores our commitment to pioneering new ways of advancing life-saving therapies for patients living with cancer,” Massacesi said.
