Seattle Genetics, Inc., a biotechnology company focused on the development and commercialization of monoclonal antibody-based therapies for the treatment of cancer, has reported that the validation period is complete and Health Canada has accepted for review its New Drug Submission (NDS) for the use of Adcetris (brentuximab vedotin) in relapsed Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL). The NDS will be reviewed under the Health Canada policy of Notice of Compliance with Conditions (NOC/c). Adcetris is an antibody-drug conjugate (ADC) directed to CD30, which is expressed in Hodgkin lymphoma and sALCL.
Adcetris (brentuximab vedotin) is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics’ proprietary technology. 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.
“Data from the pivotal clinical trials of Adcetris in relapsed HL and sALCL demonstrated a high objective response rate and manageable safety profile in heavily pre-treated patients,” said Joseph M. Connors, M.D., FRCPC, clinical director, Center for Lymphoid Cancer at BC Cancer Agency in Vancouver, Canada. “If approved in Canada, Adcetris would constitute a major step forward in how we are able to treat these patients.”
“Completing this submission is an important part of our goal to broaden the availability of Adcetris for relapsed HL and sALCL patients in need,” said Clay B. Siegall, Ph.D., president and chief executive officer of Seattle Genetics. “During the application review period, we will work in tandem with Health Canada towards our goal of making Adcetris available to patients in Canada by early 2013.”
The NDS is based on results from a pivotal trial in HL patients with relapsed or refractory disease following an autologous stem cell transplant (ASCT) and a pivotal trial in relapsed or refractory sALCL patients. Data from both trials were recently published in the Journal of Clinical Oncology (JCO).
Health Canada’s NOC/c policy is available for promising new drug therapies intended for the treatment, prevention or diagnosis of serious, life-threatening or severely debilitating diseases or conditions for which no drug is presently marketed in Canada or that represents a significant improvement in the benefit/risk profile over existing products. Conditions associated with market authorization under the NOC/c policy include a requirement that Seattle Genetics conduct clinical trials designed to confirm the clinical benefit of Adcetris in these patients. The safety and efficacy of Adcetris is under review by Health Canada and market authorization has not yet been obtained in Canada.
Seattle Genetics and Millennium: The Takeda Oncology Company are jointly developing Adcetris . Under the terms of the collaboration agreement, Seattle Genetics has US and Canadian commercialization rights and the Takeda Group has rights to commercialize Adcetris in the rest of the world. Seattle Genetics and the Takeda Group are funding joint development costs for Adcetris on a 50:50 basis, except in Japan where the Takeda Group is solely responsible for development costs.