Lenalidomide (Revlimid?, Celgene) has been granted full marketing authorization by Japan’s Ministry of Health, Labour and Welfare (MHLW) for the treatment of patients with myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenic abnormality. Lenalidomide was also approved in June 2010 in combination with dexamethasone, for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior standard therapy.
The approval of Lenalidomide was based upon the safety and efficacy results of several international trials in patients with deletion 5q MDS, which have supported regulatory approval in 19 countries worldwide.
Lenalidomide is an IMiDs compound and is continued to be evaluated in over 100 clinical trials. Celgene’s IMiDs pipeline is covered by a comprehensive intellectual property estate of U.S. and foreign issued and pending patent applications including composition-of- matter and use patents.
Lenalidomide is approved in combination with dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy in more than 50 countries, encompassing Europe, the Americas, the Middle-East and Asia, and in Australia and New Zealand it is approved in combination with dexamethasone for the treatment of patients whose disease has progressed after one therapy.
Lenalidomide is also approved in the United States, Canada and several Latin American countries, as well as Malaysia and Israel, Australia and New Zealand for patients with transfusion-dependent anemia due to Low- or Intermediate-1-risk MDS associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. Marketing Authorization Applications are currently being evaluated in a number of other countries.
Because of this potential toxicity and to avoid fetal exposure, to lenalidomide is only available under a special restricted distribution program. In the U.S. this program is called ‘RevAssist?‘. Under the conditions of the program only prescribers and pharmacists registered with the program can prescribe and dispense Lenalidomide. In addition, lenalidomide must only be dispensed to patients who are registered and meet all the conditions of the program.