ARTICLE | Clinical News

Adcetris gets Priority Review for first-line classical Hodgkin's lymphoma

January 5, 2018 5:41 PM UTC

Seattle Genetics (NASDAQ:SGEN) said FDA accepted and granted Priority Review to an sBLA for Adcetris brentuximab vedotin (SGN-35) as first-line treatment for advanced classical Hodgkin's lymphoma. Its PDUFA date is May 1.

Adcetris is approved in the U.S. to treat classical Hodgkin's lymphoma after failure of autologous hematopoietic stem cell transplantation (HSCT) or at least two multi-agent chemotherapy regimens in patients who are not autologous HSCT candidates and as post-autologous HSCT consolidation in patients at high risk of relapse or progression. It is also has accelerated approval to treat systemic anaplastic large cell lymphoma after failure of at least one prior multi-agent chemotherapy regimen and full approval to treat primary cutaneous anaplastic large cell lymphoma or CD30-expressing mycosis fungoides in patients who have received prior systemic therapy...