Takeda Pharmaceutical Company Limited and Millennium: The Takeda Oncology Company, have recieved the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) positive opinion for conditional approval of brentuximab vedotin for two indications.

The two indications are 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 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,” 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.”

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 five in 10,000 people in the European Union at the time of the submission.

Brentuximab vedotin is an antibody-drug conjugate (ADC) comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE). The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalisation into CD30-expressing tumour cells.

Millennium: The Takeda Oncology Company and Seattle Genetics are jointly developing brentuximab vedotin. Under the terms of the collaboration agreement, Seattle Genetics has US and Canadian commercialisation rights and the Takeda Group has rights to commercialize brentuximab vedotin in the rest of the world. Seattle Genetics and the Takeda Group are funding joint development costs for brentuximab vedotin on a 50:50 basis, except in Japan where the Takeda Group will be solely responsible for development costs.

Lymphoma is a general term for a group of cancers that originate in the lymphatic system. There are two major categories of lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma. Hodgkin lymphoma is distinguished from other types of lymphoma by the presence of one characteristic type of cell, known as the Reed-Sternberg cell. The Reed-Sternberg cell expresses CD30.

ALCL is a type of aggressive T-cell lymphoma, comprising about three percent of all non-Hodgkin lymphomas (NHL) in adults and between 10 and 30 percent of all NHL in children. There are two distinct forms/types of ALCL, including primary cutaneous ALCL and systemic ALCL (sALCL). sALCL is a clinically aggressive, systemic lymphoma that primarily involves lymph nodes.

Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for patients worldwide through leading innovation in medicine.