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The FDA is expected to decide on Mezigdomide for Relapsed/refractory multiple myeloma by May 13, 2027, under an NDA from Bristol Myers Squibb.
What the FDA is deciding on Mezigdomide for Relapsed/refractory multiple myeloma
The FDA is reviewing Bristol Myers Squibb's application to approve Mezigdomide for Relapsed/refractory multiple myeloma.
Oral CELMoD pill taken with carfilzomib and dexamethasone, for myeloma that has come back after at least 1 prior treatment that included an anti-CD38 antibody and lenalidomide. Patients in the SUCCESSOR-2 trial had a median of 2 prior lines of therapy.
Who the Mezigdomide decision matters to
Multiple myeloma is a cancer of plasma cells, the white blood cells that make antibodies. Abnormal plasma cells crowd the bone marrow, weaken bones and release a useless protein that can damage the kidneys.
More than a dozen drugs are approved, and 2 more are under FDA review: the CAR T cell therapy anito-cel, with a decision due December 23, 2026, and the oral drug mezigdomide, due May 13, 2027.
Prevalence: About 36,000 new US diagnoses expected in 2026 and roughly 203,000 people living with it, which puts myeloma right at the edge of the US rare disease threshold; it is 1.7% of all new cancers (NCI SEER). See our full Multiple Myeloma page for current treatments, recruiting trials, and community resources.
How Mezigdomide works
Mezigdomide: oral cereblon E3 ligase modulator (CELMoD) that drives rapid degradation of the Ikaros and Aiolos proteins myeloma cells depend on. Our full Mezigdomide profile covers how it works, side effects in plain language, and its trial history.
What an approval or a rejection of Mezigdomide would mean
An approval starts a second race rather than ending the first one: specialty pharmacy setup, insurance review, and patient assistance typically take weeks even when everything goes right. Our guide to the 90 days after a rare disease approval explains the timeline and the moves families can make on day 1.
A complete response letter would mean the FDA declined to approve in the application's current form. The letter describes what the FDA wants addressed, and the company then decides whether to resubmit, run more studies or stop. Either way, this page updates with the outcome and what it means.
Where Multiple Myeloma treatment stands today
Read our full Multiple Myeloma treatment summary
Myeloma is one of the busiest trial fields in all of cancer, with hundreds of recruiting studies, so the question is rarely whether a trial exists but which one fits the number and type of treatments you have already had.
The approved drugs fall into classes that trials combine and sequence: proteasome inhibitors (bortezomib, carfilzomib, ixazomib), immunomodulators (thalidomide, lenalidomide, pomalidomide), antibodies such as daratumumab and elotuzumab, high-dose chemotherapy with a stem cell transplant, and newer immune therapies, including CAR T cell therapies and bispecific antibodies, that aim the body's T cells at myeloma cells.
Two FDA decisions are on the calendar. Anito-cel (anitocabtagene autoleucel), a BCMA-directed CAR T cell therapy from Kite, a Gilead company, and Arcellx, is under review as a fourth-line treatment for relapsed or refractory myeloma, with a decision due December 23, 2026, based on the Phase 2 iMMagine-1 study (NCT05396885).
Mezigdomide, an oral drug from Bristol Myers Squibb that works by breaking down 2 proteins myeloma cells depend on, is under review in combination with carfilzomib and dexamethasone, with a decision due May 13, 2027; in the Phase 3 SUCCESSOR-2 trial of 479 patients it kept the disease from progressing for a median of 18.0 months versus 8.3 months without it.
Many myeloma trials are written for people who have already been treated with the 3 main drug classes. A myeloma specialist can read your treatment history against those rules in a single visit, and the International Myeloma Foundation's InfoLine and HealthTree's trial matching tool both help patients do the first pass themselves.
The Multiple Myeloma page has every treatment and trial →Meanwhile, 714 Multiple Myeloma studies are open or about to open
Whatever the FDA decides here, research on Multiple Myeloma does not stop. The most recently updated:
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- Trial Alerts, when a new trial opens or a trial changes
- Disease Updates, FDA decisions and condition news, usually 1 or 2 emails a month
Frequently asked questions
When will the FDA decide on Mezigdomide?
The FDA's target date (PDUFA date) for Mezigdomide in Relapsed/refractory multiple myeloma is May 13, 2027.
Who disclosed it: Bristol Myers Squibb. The FDA does not publish these dates.
Can it move: the FDA can act early, and a major amendment to the application can push the date back 3 months.
Source: BMS press release
What is Mezigdomide being reviewed for?
Bristol Myers Squibb submitted an NDA for Mezigdomide in Relapsed/refractory multiple myeloma.
What to know: Oral CELMoD pill taken with carfilzomib and dexamethasone, for myeloma that has come back after at least 1 prior treatment that included an anti-CD38 antibody and lenalidomide. Patients in the SUCCESSOR-2 trial had a median of 2 prior lines of therapy.
How it works: Oral cereblon E3 ligase modulator (CELMoD) that drives rapid degradation of the Ikaros and Aiolos proteins myeloma cells depend on.
More: the Mezigdomide drug page explains it in plain language.
Is there already an FDA-approved treatment for Multiple Myeloma?
Trial Friend does not have pages yet for the FDA-approved drugs for Multiple Myeloma, if there are any. The Multiple Myeloma page checks FDA drug labels for approved treatments.
Also coming: Anitocabtagene autoleucel.
Check: the Multiple Myeloma page also searches FDA drug labels for approved treatments.
What did the Mezigdomide trials show?
SUCCESSOR-2 (NCT05552976) is a Phase 3 trial that compared mezigdomide plus carfilzomib and dexamethasone (MeziKd) with carfilzomib and dexamethasone (Kd) in relapsed or refractory multiple myeloma, after a first stage that settled the 1.0mg dose. The analysis included 479 patients, 288 on MeziKd and 191 on Kd; the median age was 68, a quarter were 75 or older, the median number of prior therapies was 2, and 92.1% had already been treated with all 3 main drug classes, with 85.8% refractory to an anti-CD38 antibody and 75.8% refractory to lenalidomide.
More: the Mezigdomide drug page has the full trial history and sources.
What are the side effects of Mezigdomide?
Mezigdomide is taken with carfilzomib and dexamethasone, so the trial numbers reflect the combination. In SUCCESSOR-2, grade 3 or 4 adverse events occurred in 83.7% of patients on the mezigdomide combination versus 56.5% on carfilzomib and dexamethasone alone.
More: the Mezigdomide drug page has the safety details reported so far.
Can I get Mezigdomide before the FDA decides?
Usually only through a clinical trial or an expanded access program, and the company decides whether to offer one.
Trials: 714 Multiple Myeloma studies are open or about to open. See them.
Check your fit: Match Me compares your details with every open trial.
Expanded access: your doctor can ask Bristol Myers Squibb directly. Registered programs are listed on ClinicalTrials.gov.
How much will Mezigdomide cost?
Bristol Myers Squibb has not announced a price. Drugmakers usually set it around approval.
Help paying: drugmaker programs and charity funds usually open at launch.
Find help: the patient assistance finder lists programs by insurance type.
What happens after the Mezigdomide decision?
This page updates with the outcome the day it is announced.
If approved: getting the drug still takes time. Specialty pharmacy setup, insurance review and patient assistance often take weeks. Our guide covers what families can do on day 1.
If not approved: a complete response letter means the FDA declined the application in its current form. Many are about manufacturing or how data were presented, and companies often resubmit.
Where this date comes from
The FDA does not publish PDUFA dates; companies disclose them. This one comes from BMS press release. Dates can move, and the FDA can act early or late. This page rechecks against our calendar, which is re-verified daily.