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news.The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended conditional approval for Takeda Pharmaceuticals and Millennium adcetris (brentuximab vedotin) in Europe.
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If the CHMP recommendation is adopted by the European Commission, brentuximab vedotin, an antibody-drug conjugate (ADC), will be used to treat patients with refractory CD30 positive Hodgkin lymphoma (HL) and refractory systemic anaplastic large cell lymphoma (sALCL).
Takeda Pharmaceuticals Europe and Canada commercial operations head Trevor Smith said the company is very pleased with the CHMP positive recommendation for brentuximab vedotin.
”Takeda is dedicated to developing innovative and novel therapeutics that make a real difference to patients’ lives,” Smith added.
Millennium chief medical officer Karen Ferrante said 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.
"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," Ferrante added.