Lenalidomide
A thalidomide descendant that switches on the cell's protein-disposal system against two myeloma survival factors, and is the backbone of myeloma maintenance and many lymphoma regimens.
Approved 2006 (myeloma with dexamethasone), 2017 (post-transplant maintenance), plus MDS del(5q), mantle cell and follicular lymphoma (R2). Generic since 2022. Degrades IKZF1/IKZF3 via cereblon, killing plasma cells and co-stimulating T cells; the basis for CELMoDs and molecular-glue degraders generally.
1.Lenalidomide binds cereblon in the CRL4 ubiquitin ligase
- Route
- Oral
- Schedule
- 25 mg days 1-21 of 28 (induction); 10-15 mg continuous (maintenance); renal dose adjustment
- Dose modifications
- Hold for neutrophils <1.0 or platelets <30; thromboprophylaxis with aspirin or anticoagulant
- Monitoring
- Counts, venous thromboembolism, second primary malignancies, rash; REMS for teratogenicity
- Medicare
- Part D (self-administered)
Oral, self-administered, so it is a Part D drug: covered through a stand-alone Part D plan or Medicare Advantage drug benefit, usually on the specialty tier with 25 to 33% coinsurance until the annual cap ($2,000 in 2025, $2,100 in 2026). Generic lenalidomide entered the US in March 2022 under volume-limited licences and became fully generic in January 2026; Part D plans increasingly prefer the generic. Dispensed only through the REMS.
- Commercial insurance
- covered with prior authorisation
Covered for FDA-labelled and NCCN-listed uses, but almost always behind prior authorisation confirming diagnosis, biomarker and line of therapy; dispensed through a specialty pharmacy. Plans now require the generic where available.
- Assistance programmes
- BMS Access Support
- Bristol Myers Squibb Patient Assistance Foundation
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
- Leukemia & Lymphoma Society financial support
Part D out-of-pocket capped at $2,000 (2025) / $2,100 (2026). Medicare patients cannot use manufacturer co-pay cards; charity funds (PAN, HealthWell, CancerCare) and the Extra Help subsidy are the routes.
Sources: Medicare.gov: Drug coverage (Part D) · Medicare.gov: Costs for Medicare drug coverage (annual out-of-pocket cap). Not medical or financial advice; verify with your plan.
- Appraised for
- Multiple myeloma after 2 or more prior therapies
- Notes
- Also del(5q) MDS (TA322, 2014), untreated myeloma with dexamethasone (TA587, 2019), maintenance after transplant (TA680, 2021), and combinations with daratumumab and ixazomib. Generic since 2023, which has unlocked many combinations.
- NHS England
- Routinely funded for the appraised indication (or via managed access)
Sources: NICE TA171 · SMC advice: lenalidomide. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
- 27 Dec 2005ApprovalUS
MDS del(5q)
- 29 Jun 2006ApprovalUS
Myeloma with dexamethasone
- Mar 2022Label changeUS
First generics launch (volume-limited)
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2006 | Relapsed myeloma with dexamethasone |
| US | 2015 | Newly diagnosed myeloma with dexamethasone |
| US | 2017 | Maintenance after autologous transplant |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Neutropenia MM-009/010 with dexamethasone | — | 35% |
| Venous thromboembolism without prophylaxis | 12% | — |
| Second primary malignancy maintenance after melphalan (CALGB 100104, 7-8% vs 3%) | 7% | — |
Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United Statesgeneric | — | ~$20,000 per month (brand, 2022); generics volume-limited until 2026 | — |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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CEPHEUS extends the quadruplet standard to patients who are not going to transplant, closing the gap between transplant-eligible and ineligible populations. It is also one of the first phase 3 trials to be designed around MRD-negativity as the primary endpoint, which could shorten future myeloma trials by years. Frailer patients still need dose-adapted approaches.
PERSEUS, with the earlier GRIFFIN and CASSIOPEIA trials, made a four-drug daratumumab quadruplet the standard for fit patients heading to transplant. It also introduced MRD-directed stopping of the antibody, a step towards treatment that is deep but not indefinite. Whether transplant itself remains necessary on top of a quadruplet is now the open question.
MAIA made a daratumumab-based triplet the standard first treatment for older or frail myeloma patients, replacing Rd alone. It proved an anti-CD38 antibody could improve survival, not just delay progression, when used up front. Quadruplets built on this backbone are now being tested in the same population.
Latest papers
topQuery for this drug: (TITLE:"Lenalidomide" OR ABSTRACT:"Lenalidomide" OR TITLE:"Revlimid" OR ABSTRACT:"Revlimid") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Lenalidomide, not a curated reading list.
Pages like this
not linked directly; found by shared links- ProductBortezomib
Shares Kenneth C. Anderson, Paul G. Richardson, CEPHEUS, IMROZ.
- ProductDaratumumab
Shares CEPHEUS, MGUS and smouldering myeloma, MRD-guided treatment-free intervals in myeloma, PERSEUS.
- TermMRD negativity (myeloma, 10⁻⁵ / 10⁻⁶)
Shares MRD-guided treatment-free intervals in myeloma, PERSEUS, MAIA: adding daratumumab to lenalidomide-dexamethasone for older patients with newly diagnosed myeloma who cannot have a transplant, PERSEUS: daratumumab added to bortezomib-lenalidomide-dexamethasone around autologous transplant in newly diagnosed myeloma.
- ProductThalidomide
Shares Venous thromboembolism (VTE), Immunomodulatory drugs (IMiDs) and CELMoDs, PROTACs & molecular glues (targeted protein degradation), Bristol Myers Squibb.
- ProductPomalidomide
Shares Immunomodulatory drugs (IMiDs) and CELMoDs, Ubiquitin–proteasome system & protein homeostasis, PROTACs & molecular glues (targeted protein degradation), Bristol Myers Squibb.
- ProductGolcadomide
Shares Ubiquitin–proteasome system & protein homeostasis, Follicular lymphoma, PROTACs & molecular glues (targeted protein degradation), Bristol Myers Squibb.
- TargetCD38
Shares MAIA: adding daratumumab to lenalidomide-dexamethasone for older patients with newly diagnosed myeloma who cannot have a transplant, PERSEUS: daratumumab added to bortezomib-lenalidomide-dexamethasone around autologous transplant in newly diagnosed myeloma, CEPHEUS: daratumumab quadruplet for newly diagnosed myeloma patients not having a transplant, with MRD-negativity as the main endpoint, Multiple myeloma.
- TechnologyAutologous stem cell transplant (high-dose therapy)
Shares Paul G. Richardson, PERSEUS, PERSEUS: daratumumab added to bortezomib-lenalidomide-dexamethasone around autologous transplant in newly diagnosed myeloma, Primary CNS lymphoma.