Pomalidomide · Regulatory label update

FDA supplemental approval: Pomalyst (REMS)

U.S. Food and Drug Administration · April 27, 2026

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AI Summary

The FDA approved a supplemental REMS submission for pomalidomide (Pomalyst) on 27 April 2026, covering four oral capsule strengths (1, 2, 3, and 4 mg). This is a regulatory action establishing risk management requirements; it does not report clinical trial efficacy, safety outcomes, or comparative benefit data.

What was studied

Regulatory label update.

Key findings

Supplemental REMS approval granted for pomalidomide (Pomalyst) on 2026-04-27 Four oral capsule strengths approved: 1 mg, 2 mg, 3 mg, and 4 mg

Safety

This record does not contain clinical trial results, efficacy data, or safety outcomes.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

FDA supplemental approval of a Risk Evaluation and Mitigation Strategy (REMS) for pomalidomide; establishes regulatory requirements but does not report clinical efficacy or safety trial outcomes.

Reported figures

Quoted from the source exactly as published.

Approval date2026-04-27

Product formulations approved4 capsule strengths (1 mg, 2 mg, 3 mg, 4 mg)

Caveats

This record does not contain clinical trial results, efficacy data, or safety outcomes.
REMS approval indicates risk management requirements but does not establish clinical benefit or comparative efficacy.
No patient population, study design, or outcome metrics reported.
Record does not specify the nature of the risk mitigation strategy or monitoring requirements.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

insufficient

Regulatory action record; not a clinical study design.

Directness

insufficient

REMS approval does not directly measure clinical outcomes.

Consistency

insufficient

Single regulatory action; consistency with other evidence not addressed.

Risk of bias

insufficient

Regulatory submission; bias assessment not applicable.

Sample adequacy

insufficient

No patient sample reported in regulatory record.

Source abstract

Drugs@FDA record for application NDA204026. This is a regulatory action record, not a clinical study. Brand name: POMALYST. Active ingredient: POMALIDOMIDE. Sponsor: BRISTOL. Submission type: SUPPL (supplement). Submission class: REMS. Approval status date: 2026-04-27. Products: POMALYST, CAPSULE, ORAL, POMALIDOMIDE 3MG; POMALYST, CAPSULE, ORAL, POMALIDOMIDE 1MG; POMALYST, CAPSULE, ORAL, POMALIDOMIDE 4MG; POMALYST, CAPSULE, ORAL, POMALIDOMIDE 2MG.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

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