The European Medicines Agency (EMEA) has granted a positive opinion on Celgene Corporation (Nasdaq: CELG)’s novel oral cancer drug REVLIMID® (lenalidomide) for use in combination with dexamethasone as a treatment for patients with multiple myeloma who have received at least one prior therapy.
EMEA's Committee for Medicinal Products for Human Use (CHMP) has already forwarded its recommendation of approval for the said drug to the European Commission – the body who issues the final marketing approval in 2-3 months time.
Already approved by the USFDA as a treatment in combination with dexamethasone for patients previously treated with multiple myeloma, REVLIMID® has obtained Orphan Drug designation in the EU, US and Australia.
Find more details from the full report.
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