Celgene's Thalomid gets FDA OK for MM
New Jersey, USA-based Celgene has announced that the supplemental New Drug Application for its Thalomid (thalidomide) has been granted accelerated approval status by the Food and Drug Administration. The sNDA covers the drug's use in combination with dexamethasone as a treatment for newly-diagnozed multiple myeloma.
Celgene added that the drug's effectiveness is based on patient response rates rather than on data from controlled trials, which were not undertaken. In addition, the safety profile of the combined therapy showed an increase in side effects such as constipation, thrombosis and rash when compared with dexamethasone alone. Company chief executive Sol Barr, said that the drug addressed an unmet medical need.
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