Lenalidomide approved in China for treatment of transplant-ineligible MM patients

On 28 February 2018, lenalidomide was granted approval by the China Food and Drug Administration (CFDA) to treat previously untreated transplant-ineligible Multiple Myeloma (MM) patients, in combination with dexamethasone. The incidence of MM in China is increasing, due to a rise in the aging population as well as improved diagnosis, and this is long-awaited news for Chinese MM patients who have not had access to the same medicines as patients in Europe and the USA.

This decision follows publication of the final data from the phase III FIRST trial, which demonstrated a significant improvement in the median Progression-Free Survival (PFS) in transplant-ineligible Newly Diagnosed (ND) MM patients given continuous lenalidomide plus dexamethasone (Rd continuous), in comparison with melphalan, prednisone, and thalidomide (MPT).

Lenalidomide, manufactured by Celgene Corporation, is marketed in China by BeiGene. China operates a national insurance scheme to give patients access to drugs, but there is a restriction as to which drugs are available on this National Reimbursement Drug List. Recent negotiations between the Chinese government led to lenalidomide being added to this list with this extended indication; it was first approved in China in 2013 to treat MM patients, combined with dexamethasone, as a second-line regimen.