FDA panel backs Adcetris

FDA's Oncologic Drugs Advisory Committee unanimously recommended accelerated approval of Adcetris brentuximab from Seattle Genetics Inc. (NASDAQ:SGEN) to treat patients with Hodgkin's lymphoma who relapse after autologous stem cell transplant and to treat patients with anaplastic large cell lymphoma (ALCL). Seattle Genetics has requested full approval for both indications. Adcetris is under Priority Review with an Aug. 30 PDUFA date.

While the panel agreed that Adcetris was effective, they did not feel full approval should be granted because the safety of Adcetris could not be properly assessed in the two single-arm pivotal Phase II trials included in the BLAs. ...