Health Canada To Review Adcetris for Hodgkin's, ALCL

Seattle Genetics is announcing that the required validation period has ended and Health Canada has accepted the company's New Drug Submission (NDS) for review for the antibody drug conjugate Adcetris (brentuximab vedotin) for use against relapsed Hodgkin's lymphoma and for systemic anaplastic large cell lymphoma (ALCL).

The NDS is based on data from a pivotal trial in patients with relapsed or refractory Hodgkin's following an autologous stem cell transplantation, and another pivotal trial in patients with relapsed or refractory systemic anaplastic large cell lymphoma.

Health Canada intends to review the NDS under its policy of Notice of Compliance with Conditions (NOC/c). This policy is intended for drugs or treatments that are either meant for conditions for which no other treatment exists in Canada, or for treatments that represent a substantial improvement over existing treatments.

"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."

Source: MarketWatch