Seattle Genetics, Inc. (Nasdaq:SGEN) announced today 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.
"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).