Celgene receives Japan's MHLW approval for REVLIMID in deletion 5q myelodysplastic syndrome patients

Celgene International Sàrl (NASDAQ: CELG) announced that REVLIMID (lenalidomide) 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. REVLIMID 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 REVLIMID 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.

As a result of the approval, REVLIMID will be available through RevMate™, the company's proprietary distribution program. Celgene is now registering physicians and medical centers throughout the country into RevMate as part of its strategic launch.

Source:

 Celgene International Sàrl

Comments

The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
Post a new comment
Post