Celgene granted CHMP backing for Revlimid

Celgene has announced that Europe's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on Revlimid as a multiple myeloma therapy.

Following an Article 20 review of the approved treatment, the European Medicines Agency scientific committee has endorsed the benefit-risk profile of the drug when used in combination with dexamethasone.

This follows an assessment of clinical data in the approved indication for Revlimid, including the key studies MM-009 and MM-010, in addition to a full review of safety data pertaining to second primary malignancies (SPMs).

A statement from the company said: "Of note, the analyses for newly diagnosed multiple myeloma confirmed there was no correlation between treatment duration with Revlimid and the risk of SPMs."

The CHMP also recommended that the product information for the drug should be updated to include data from this review.

Earlier this year, Celgene also received backing from the UK's National Institute for Health and Clinical Excellence for its drug Thalidomide to be used as a treatment for multiple myeloma.