Also known as: thalidomide analogue
Lenalidomide is an oral immunomodulatory imide drug (IMiD), also described as a cereblon E3 ligase modulator, used in hematologic malignancies such as multiple myeloma and selected lymphomas/MDS. It is marketed under the brand name Revlimid. U.S. approval was first granted in 2005.
FDA approved iberdomide (Zenbexus) with daratumumab and dexamethasone for pretreated myeloma. The EXCALIBER-RRMM trial showed a 41% MRD-negative complete response rate vs 21%.
Blockbuster drugs worth hundreds of billions face generic competition as patents expire through 2032. Indian drugmakers could capture $3-5 billion of the opportunity, while GSK and Bristol Myers Squibb prepare for revenue losses.
FDA approved subcutaneous isatuximab-irfc for multiple myeloma. Phase 3 EMN24 trial showed 77% MRD negativity with Isa-KRd quadruplet therapy. Phase 2 study showed 77% hematologic response rate in relapsed/refractory AL amyloidosis.
Epcoritamab plus lenalidomide cut progression risk by 60% in R/R DLBCL in a phase 3 trial. Five-year AUGMENT follow-up supports R2 in indolent NHL; a phase 2 penpulimab-lenalidomide-R-GemOx trial showed activity in DLBCL.
A Cleveland Clinic study found no racial survival disparities in multiple myeloma when patients have equal access to modern therapies. Clinical cases demonstrate long-term remission with second stem cell transplants and targeted agents like daratumumab.
Long-term results from the phase III TRIANGLE trial show ibrutinib-based regimens improve survival in younger mantle cell lymphoma patients, while the ECHO trial establishes a new standard for older patients. Advances in CAR T-cell and bispecific antibody therapies are reshaping treatment for this rare blood cancer. The findings were presented at the annual MCL Consortium meeting.
The FDA has accepted an NDA for iberdomide in combination with anti-CD38 antibodies for relapsed or refractory multiple myeloma. A phase 2 study reports a 39% near complete response rate for the DaraKPd quadruplet therapy with durable MRD negativity. Preclinical research shows the RXR agonist IRX4204 sensitizes myeloma cells to ferroptosis and enhances lenalidomide efficacy.
The phase III frontMIND trial showed that adding tafasitamab and lenalidomide to R-CHOP chemotherapy reduced the risk of progression by 25% in patients with high-risk B-cell lymphomas. The 3-year progression-free survival was 67.3% with the combination versus 60.7% with R-CHOP alone. A dual-targeted CD19/CD20 immunotherapy regimen has also been approved in Australia for relapsed follicular lymphoma.
An interim phase 3 analysis showed mezigdomide plus carfilzomib and dexamethasone reduced the risk of progression or death in relapsed/refractory multiple myeloma. The SUCCESSOR-2 study remains ongoing and will assess overall survival and safety.
New data from the American Cancer Society shows the U.S. cancer death rate has dropped 34% since 1991, preventing nearly five million deaths. More than 18 million Americans are living after a cancer diagnosis, with that number expected to surpass 22 million by 2030.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07764978 |
Study of AZD0120 in Newly Diagnosed Multiple Myeloma Ineligible for ASCT |
RECRUITING | PHASE3 |
| NCT07764861 |
A Open-Label Phase in Participants With Multiple Myeloma |
NOT_YET_RECRUITING | PHASE2 |
| NCT07740486 |
A Study Comparing Treatment With Teclistamab and Talquetamab Versus Daratumumab and Lenalidomide in Patients With Multiple Myeloma After Stem Cell Transplant Who Still Have Detectable Disease |
NOT_YET_RECRUITING | PHASE3 |
| NCT07735637 |
A Phase III, Multicentre Study to Evaluate Consolidation Treatment With AZD0120 Compared With ASCT, in Participants With Newly Diagnosed Multiple Myeloma Who Are Transplant Eligible (DURGA-6). |
NOT_YET_RECRUITING | PHASE3 |
| NCT07719855 |
A Multicenter, Prospective, Open-Label, Randomized Controlled Clinical Study of Orelabrutinib Combined With Obinutuzumab and Lenalidomide Versus Obinutuzumab Plus Chemotherapy for Treatment-Naive Follicular Lymphoma |
NOT_YET_RECRUITING | PHASE3 |
| NCT07719543 |
Efficacy and Safety of Lenalidomide in Patients With IgG4-Related Disease |
NOT_YET_RECRUITING | PHASE3 |
| NCT07717177 |
AI-Driven Treatment Strategy vs ZR2 in Older Treatment-naive Patients With LBCL |
NOT_YET_RECRUITING | PHASE2 |
| NCT07709884 |
A Single-center, Prospective, Single-arm Clinical Study Exploring the Treatment of Newly Diagnosed Multiple Myeloma Patients With t(11;14) Suitable for Transplantation Using the SonKRd Regimen |
NOT_YET_RECRUITING | PHASE4 |
| NCT07671287 |
GMMG-HD11/DSMM XXI/64007957MMY3010 |
NOT_YET_RECRUITING | PHASE3 |
| NCT07665450 |
A Study of Ramantamig Plus Daratumumab Versus Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (DVRd) or Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Participants With NDMM For Whom Stem Cell Transplant is Not Planned |
NOT_YET_RECRUITING | PHASE3 |
