European Medicines Agency (EMA) has accepted the filing of the Marketing Authorization Application (MAA) for brentuximab vedotin (Adcetris™, Takeda Pharmaceutical and Millennium: The Takeda Oncology Company) for the treatment of relapsed or refractory Hodgkin lymphoma (HL) and relapsed or refractory systemic anaplastic large cell lymphoma (sALCL). The Marketing Authorization Application was filed by Takeda Global Research & Development Centre (Europe). Acceptance of the MAA confirms that the submission is sufficiently complete to permit a substantive review.
Brentuximab is an antibody-drug conjugate (ADC) comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a potent, synthetic drug, monomethyl auristatin E (MMAE) utilizing proprietary technology developed by Seattle Genetics. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells. This approach allows for the selective targeting of CD30-expressing cancer cells.
“This filing brings us a step closer to providing a new treatment option to patients in the European Union with relapsed or refractory HL and relapsed or refractory sALCL, two areas of unmet medical need,” said Nancy Simonian, M.D., Chief Medical Officer, Millennium. “We look forward to working with the EMA on this submission.”
The MAA contains data from pivotal phase II studies in relapsed or refractory Hodgkin lymphoma and relapsed or refractory sALCL. Top line results from these studies were presented at the 52nd American Society of Hematology (ASH) Annual Meeting in December 2010.
In January 2009 brentuximab received orphan product designations for the treatment of patients with HL and sALCL 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 E.U. at the time of the submission.