EC clears Celgene's Thalidomide in MM

US drugmaker Celgene's Thalidomide Pharmion has been approved by the European Commission for use in combination with melphalan and prednisone as a treatment for patients with newly-diagnosed multiple myeloma. The firm's MM franchise already includes Revlimid (lenalidomide), the first new oral drug in more than 40 years for the deadly blood cancer, which affects 50,000 people worldwide.

Celgene's Thalomid (thalidomide) was approved by the US Food and Drug Administration in May 2006 as an oral treatment in combination with dexamethasone for patients newly-diagnosed with MM. In 2008, the Australian Drug Evaluation Committee granted Thalidomide Pharmion marketing approval for use in combination with melphalan and prednisone for patients with untreated MM or ineligible for high dose chemotherapy. In addition, the agent was granted marketing approval in combination with dexamethasone for induction therapy prior to high dose chemotherapy with autologous stem cell rescue, for patients with untreated MM.

Thalidomide was first approved in the 1950s as a treatment for morning sickness in pregnant women. However, the drug caused severe deformities in the children of users. The European approval conditions include a pregnancy prevention program.