Celgene's Revlimid approved in China for MM; gets PDUFA date in USA for mantle cell lymphoma

Celgene Corp’s (Nasdaq: CELG) European subsidiary revealed that Revlimid (lenalidomide) has been granted full approval, which includes an Import Drug License (IDL), by the China State Food and Drug Administration (SFDA) for use in combination with dexamethasone as a treatment for patients with relapsed or refractory multiple myeloma who have received at least one prior therapy.

The approval of the firm’s blockbuster drug Revlimid, which generated sales of $3.77 billion last year, is based upon the safety and efficacy results of multiple pivotal randomized Phase III international clinical trials in patients with relapsed or refractory multiple myeloma. Results from a large, Phase II bridging study (MM-021) of lenalidomide and low-dose dexamethasone in 159 Chinese patients, who had relapsed or refractory multiple myeloma, also supported the submission and approval.

Revlimid will be available only through a proprietary distribution program developed by Celgene. The company is working to supply Revlimid to the China market as soon as possible. Certain standard government processes must be followed prior to launch. Celgene expects Revlimid to be available to patients late in the second quarter of 2013.