Mezigdomide for Relapsed/refractory multiple myeloma
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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 is being decided
Bristol Myers Squibb has an NDA under FDA review for Mezigdomide in 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.
About the drug
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 each outcome 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. CRLs are often about manufacturing or data presentation rather than efficacy, and resubmission is common. Either way, this page updates with the outcome and what it means.
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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.
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 1.0 mg 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 lists the warnings in full.
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.