Thalidomide sNDA Granted Approval for Newly Diagnosed Multiple Myeloma

Celgene Corporation announced that the US Food and Drug Administration (FDA) has granted accelerated approval to its Supplemental New Drug Application (sNDA) for thalidomide (Thalomid) in combination with dexamethasone for the treatment of newly diagnosed multiple myeloma. The effectiveness of thalidomide is based on response rates. There are no controlled trials demonstrating a clinical benefit, such as an improvement in survival. Multiple myeloma is the second most common blood cancer in the United States, affecting approximately 50,000 people.

STEPS Program

Thalidomide is available via the System for Thalomid Education and Prescribing Safety (STEPS). Through the use of the STEPS program, more than 130,000 US patients have had safe access to thalidomide since its market introduction in July 1998.

The safety profile for thalidomide in multiple myeloma has shown an increase in side effects with thalidomide and dexamethasone as compared to dexamethasone alone. The most common adverse events were constipation, sensory neuropathy, confusion, hypocalcemia, edema, dyspnea, thrombosis/embolism, and rash/desquamation.