Celgene International Sàrl, a subsidiary of Celgene Corporation will be requesting the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for a re-examination of the negative opinion announced by the agency regarding the Marketing Authorisation Application (MAA) submitted for Istodax (romidepsin) for the treatment of relapsed or refractory peripheral t-cell lymphoma (PTCL).
During the regulatory review process, it was acknowledged that romidepsin demonstrated anti-tumour activity, however, in the absence of a reference treatment in the clinical trial submitted to support the application, the committee was unable to agree that the benefit/risk relationship of romidepsin was demonstrated.
Celgene remains convinced of the favorable benefit/risk profile of romidepsin, which has the potential to offer an important new treatment option in this area of high unmet medical need in the EU, where no agents are currently approved. The company will therefore, in accordance with European regulations, request a re-examination of the CHMP opinion.
Patients will continue to have access to romidepsin through clinical studies and in the EU under a named patient program (NPP) where available.
Istodax is approved in the United States for the treatment of patients with cutaneous t-cell lymphoma (CTCL) who have received at least one prior systemic therapy. Istodax is also approved in the United States for the treatment of patients with peripheral t-cell lymphoma (PTCL) who have received at least one prior therapy.
Istodax (romidepsin) is a member of a class of cancer drugs known as histone deacetylase (HDAC) inhibitors. HDACs catalyze the removal of acetyl groups from acetylated lysine residues in histones, resulting in the modulation of gene expression. HDACs also deacetylate non-histone proteins, such as transcription factors. HDAC inhibitors can be divided into four main classes: cyclic tetrapeptides (I), short-chain fatty acids (II), hydroxamic acids (III), and benzamides (IV). The cyclic peptide structure of Istodax is novel among the cyclic tetrapeptides. In vitro, Istodax causes the accumulation of acetylated histones, and induces cell cycle arrest and apoptosis of some cancer cell lines.
Peripheral T-cell lymphoma is a term that encompasses a number of different malignancies of T-cell origin that account for about 10-15% of all cases of non-Hodgkin's lymphoma. PTCL can occur at any age from young adulthood to old age and is slightly more common in men than in women. It is a particularly aggressive form of lymphoma with a short median duration of life expectancy (approximately two years) from diagnosis.
Celgene International Sàrl, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation.