Takeda China has received approval from the country’s National Medical Products Administration (NMPA) for Adcetris (brentuximab vedotin) to treat relapsed or refractory systemic anaplastic large cell lymphoma (sALCL) or CD30-positive Hodgkin lymphoma in adults.
Adcetris is an antibody-drug conjugate (ADC) based on Seattle Genetics’ technology, made up of an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to monomethyl auristatin E (MMAE), a microtubule disrupting agent.
The drug secured priority review from the Center for Drug Evaluation in June last year and has now obtained NMPA approval.
Takeda China president Sean Shan said: “This ‘fast-track’ approval process demonstrates the Chinese government’s determination to accelerate the introduction of highly innovative drugs to China’s patients.
“As Takeda aims to put the patient at the centre of everything we do, we are committed to leveraging our global R&D capabilities and local operations to accelerate the pace at which we bring innovative drugs to address the unmet needs of patients in China and support the government’s ‘Healthy China 2030’ initiative.”
In addition, Takeda Pharmaceutical received the European Commission (EC) extended approval for Adcetris to treat adults with previously untreated sALCL in combination with cyclophosphamide, doxorubicin, prednisone (CHP).
This EC authorisation comes from data of the Phase III ECHELON-2 clinical trial, which met its primary endpoint with a statistically significant improvement in progression-free survival (PFS) when treated with Adcetris combination.
Furthermore, the safety profile of the combination was comparable to cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) and consistent with the drug’s established profile in combination with chemotherapy.
The drug obtained conditional marketing authorisation from the EC in October 2012 for treating various lymphomas, including Stage IV Hodgkin lymphoma, sALCL and CD30-positive cutaneous T-cell lymphoma (CTCL).
In a separate development, Takeda teamed up with plasma firms for Covid-19 hyperimmune therapy last month.