FDA Approves Revlimid (lenalidomide) for the Treatment of Patients with Relapsed or Refractory Mantle Cell Lymphoma

Lenalidomide  (Revlimid)

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Jun. 5, 2013– Celgene Corporation today announced the U.S. Food and Drug Administration (FDA) has approved the company’s supplemental new drug application (sNDA) for Revlimid (lenalidomide) for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.

Revlimid is used to treat a certain type of myelodysplastic syndrome (a group of conditions in which the bone marrow produces blood cells that are misshapen and does not produce enough healthy blood cells) caused by an abnormal chromosome. Revlimid is also used to treat anemia (a lack of red blood cells in the body) and along with dexamethasone for the treatment of multiple myeloma (a type of cancer of the bone marrow) who have received at least one prior therapy.

Lenalidomide  (Revlimid) is a derivative of thalidomide introduced in 2004.

It was initially intended as a treatment for multiple myeloma, for which thalidomide is an accepted therapeutic treatment. Lenalidomide has also shown efficacy in the class of hematological disorders known as myelodysplastic syndromes (MDS). Lenalidomide has significantly improved overall survival in myeloma (which generally carries a poor prognosis), although toxicity remains an issue for users.  It costs $163,381 per year for the average patient.

Use in USA -

On June 29, 2006, lenalidomide received U.S. Food and Drug Administration(FDA) clearance for use in combination with dexamethasone in patients with multiple myeloma who have received at least one prior therapy.

As of 2011, the FDA has initiated an ongoing review of Revlimid. The review focuses on clinical trials which found that Revlimid caused an increased risk of developing new malignancies such as acute myelogenous leukemia (AML) and B-cell lymphoma.The FDA is currently advising all patients on Revlimid to continue their treatment

Use in the UK -

On 23 April 2009, The National Institute for Health and Clinical Excellence(NICE) issued a Final Appraisal Determination (FAD) approving lenalidomide, in combination with dexamethasone, as an option to treat patients who suffer from multiple myeloma who have received two or more prior therapies in England and Wales.

Use in Australia -

While lenalidomide is not approved for first-line treatment of multiple myeloma in Australia, in clinical trials of newly diagnosed multiple myeloma, a four-fold increase in the incidence of second primary malignancies has been observed in patients receiving lenalidomide (7.0%) compared to controls (1.8%). These included cases of acute myeloid leukaemia, myelodysplastic syndrome and solid tumours in patients receiving lenalidomide.