REVLIMID is a thalidomide analogue indicated for the treatment of adult patients with: Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities...

Revlimid is a medicine used for the treatment of certain cancers and serious conditions affecting blood cells and bone marrow, namely multiple myeloma, myelodysplastic syndromes and mantle cell and follicular lymphoma....It is used in patients with a genetic abnormality (called deletion 5q) when other treatments are not adequate.

The NCCN Guidelines are based on extensive evaluation of the reviewed risk-based data and indicate current approaches for managing patients with MDS. Five drugs approved by the FDA for treating specific subtypes of MDS include lenalidomide for patients with del(5q) cytogenetic abnormalities...

lower risk MDS with del 5q: lenalidomide. Anaemia of lower risk MDS with del 5q, compared with that of other lower risk MDS, shows lower response rates and significantly shorter responses to ESA [69]. However after ESA failure, it responds to lenalidomide (LEN) in 60%–65% of the subjects...

In this interim analysis we confirm that low dose LEN (5 mg) in anemic non-TD low risk MDS del(5q) patients prolongs the period of time to TD (75.7 mo vs 25.9 mo), improves Hb levels (72.5% of ER) and induces clonal responses (70% complete CyR), ie potentially more responses than in historical series of MDS del(5q) treated with LEN at time of TD, with a manageable safety profile, and no increased progression rate.

...The patient must be diagnosed with low risk MDS (low and intermediate-1 IPSS) associated with 5q deletion, either as an isolated abnormality or accompanied by other additional cytogenetic abnormalities...MDS Del(5q) with transfusion-independent anaemia (Hb ≤ 12 g/dL), and documented confirmation that no packed red blood cells transfusion due to the patient's underlying condition (MDS) has been received...To assess if treatment with Revlimid (Lenalidomide) extends the period until the progression to MDS of(5q) considered as transfusion independent, documented verification that the patient suffering from anemia due to MDS requires transfusion of at least 2 UCH/56 days (2 months) with a minimum follow up of 112 days (4 months). Revlimid will be compared to the current standard treatment for patients with low risk MDS associated with the loss of 5q without transfusion dependent anemia, which is the therapeutic abstention and monitoring until its progression...

Among patients who were treated with len (n=100), 50% achieved a response. There was a trend for higher response rate among patients with >50% del 5q metaphases with (42/80) 53% response rate compared to (8/20) 40% among those with <50%. (p=0.32)...The number of cells harboring del 5q among isolated del 5q MDS patients using regular karyotyping “clone size by conventional cytogenetics” correlated with severity of anemia, trend for better response to len and trend for better overall survival.

We treated by lenalidomide 55 (42 female; 13 male; median age 69) chronically transfused lower risk MDS patients with del(5q) (45) and non-del(5q) (10). Response, meaning transfusion independence (TI) lasting ≥ eight weeks, was achieved in 38 (90%) of analyzed patients with del(5q),...Lenalidomide represents effective treatment for del(5q) group...

We evaluated clinical outcomes of 295 lenalidomide-treated patients from two clinical trials (MDS-003 and MDS-004) and 125 untreated red blood cell (RBC) transfusion-dependent patients with del(5q) Low- or Intermediate-1 (Int-1)-risk MDS from a large multicenter registry...In conclusion, lenalidomide treatment does not increase AML progression risk, but instead confers a possible survival benefit in RBC transfusion-dependent patients with del(5q) Low- or Int-1-risk MDS.