Published on July 21, 2012 at 5:25 AM
The CHMP positive opinion for brentuximab vedotin will now be reviewed by the European Commission (EC). If the CHMP recommendation is formally adopted by the EC, brentuximab vedotin would be approved for marketing in the 27 member states of the European Union.
"CHMP's positive opinion and recognition of the clinical benefit of brentuximab vedotin takes us a step closer to providing a targeted treatment option for patients with relapsed or refractory Hodgkin lymphoma or relapsed or refractory systemic anaplastic large cell lymphoma," said Karen Ferrante, M.D., Chief Medical Officer, Millennium. "With no new treatments approved for relapsed or refractory Hodgkin lymphoma in over thirty years, this patient population represents an area of high unmet medical need."
In January 2009 brentuximab vedotin received orphan product designations for the treatment of patients with HL or ALCL in the European Union from the Committee for Orphan Medicinal Products (COMP). Orphan medicinal product designation is conferred upon products for diseases that affect no more than 5 in 10,000 people in the European Union at the time of the submission.
Source: Millennium: The Takeda Oncology Company