Millennium: The Takeda Oncology Company and, Takeda Pharmaceutical Company Limited (TSE:4502, "Takeda") today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for conditional approval of brentuximab vedotin for two indications: (1) the treatment of adult patients with relapsed or refractory CD30 positive Hodgkin lymphoma (HL) following autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, and (2) for the treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL). Brentuximab vedotin is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical HL and sALCL. The CHMP opinion is based on data from clinical trials and other supportive data in relapsed or refractory HL and relapsed or refractory sALCL.
“We are very pleased with the CHMP positive recommendation for brentuximab vedotin”
"We are very pleased with the CHMP positive recommendation for brentuximab vedotin," said Trevor Smith, Head of Commercial Operations, Europe & Canada, Takeda Pharmaceuticals. "Takeda is dedicated to developing innovative and novel therapeutics that make a real difference to patients' lives. If approved, brentuximab vedotin will be the third product in the Takeda oncology franchise to be launched in Europe. Brentuximab vedotin has the potential to make a significant difference to patients with relapsed or refractory Hodgkin lymphoma or relapsed or refractory systemic anaplastic large cell lymphoma."