Lenalidomide · Regulatory label update

FDA supplemental approval: Lenalidomide (REMS)

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

Regulatory Update Why this matters to you Expert discussion

An action by a regulator. Authoritative on labelling and availability.

AI Summary

This is an FDA supplemental approval dated 27 April 2026 for a REMS (Risk Evaluation and Mitigation Strategy) submission for lenalidomide capsules in four strengths (5 mg, 15 mg, 20 mg, 25 mg oral) by sponsor QILU. The record is regulatory in nature and contains no clinical trial results, efficacy data, or comparative benefit information.

What was studied

Regulatory label update.

Key findings

Safety

This record does not contain clinical trial results, efficacy data, safety findings, or comparative 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 lenalidomide; this is a regulatory action, not a clinical trial, and does not report efficacy or comparative clinical outcomes.

Reported figures

Quoted from the source exactly as published.

Approval date2026-04-27

Strengths approved5 mg, 15 mg, 20 mg, 25 mg

Caveats

This record does not contain clinical trial results, efficacy data, safety findings, or comparative outcomes.
REMS approval pertains to risk mitigation strategy requirements only; the record does not report why the REMS was required or modified.
Formulation, dosing, indication, and clinical context are not provided in this regulatory record.
No information on patient population, eligible indications, or clinical use is stated in the source.

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; no study design applicable.

Directness

insufficient

Record does not contain clinical trial data or outcome measures.

Consistency

insufficient

No comparative or comparative efficacy data provided in record.

Risk of bias

insufficient

Not a clinical study; bias assessment not applicable.

Sample adequacy

insufficient

Regulatory record; no trial population or sample size.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Drugs@FDA record for application ANDA217265. This is a regulatory action record, not a clinical study. Brand name: LENALIDOMIDE. Active ingredient: LENALIDOMIDE. Sponsor: QILU. Submission type: SUPPL (supplement). Submission class: REMS. Approval status date: 2026-04-27. Products: LENALIDOMIDE, CAPSULE, ORAL, LENALIDOMIDE 25MG; LENALIDOMIDE, CAPSULE, ORAL, LENALIDOMIDE 15MG; LENALIDOMIDE, CAPSULE, ORAL, LENALIDOMIDE 5MG; LENALIDOMIDE, CAPSULE, ORAL, LENALIDOMIDE 20MG.

Follow from this

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

QiluLenalidomide