Refusal of the marketing authorization for romidepsin

On 19 July 2012, the European Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorization for the medicinal product romidepsin (Istodax), intended for the treatment of peripheral T-cell lymphoma. The company that applied for authorization is Celgene Europe Ltd. The applicant requested a re-examination of the opinion. After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorization on 15 November 2012. Read more here.