Seattle Genetics files sBLA for Adcetris in relapsed Hodgkin lymphoma and systemic ALCL

US biotech firm Seattle Genetics (Nasdaq: SGEN) has submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration supporting the use of Adcetris (brentuximab vedotin) for retreatment and extended duration beyond 16 cycles of therapy in relapsed Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL).

Adcetris is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of HL and sALCL, that was granted accelerated approval by the FDA in August 2011 for relapsed HL and relapsed sALCL. The drug generated sales of $138.2 million for the company, which holds rights in the USA and Canada, in 2012. Adcetris recently gained approval from Health Canada for relapsed HL and sALCL (The Pharma Letter February 4).

“The sBLA submission includes data demonstrating Adcetris activity in managing HL and sALCL when used in the retreatment setting, as well as beyond the 16 cycles described in our current label, while retaining a manageable safety profile,” said Clay Siegall, president and chief executive of Seattle Genetics, adding: “Our goal is to broaden the Adcetris US labeling claims to provide both patients and physicians the opportunity to incorporate Adcetris into additional HL and sALCL treatment settings. The sBLA submission includes data that support these uses and we look forward to the regulatory outcome.”