Seattle Genetics antibody drug conjugate, brentuximab vedotin or Adcetris, remains on track for its hearing at FDA on Thursday. A briefing from the FDA staff report on the drug revealed no big surprises or negatives. Adcetris is applying for approval to treat patients with Hodgkin's lymphoma and anaplastic large cell lymphoma (ALCL).
The FDA did note that both Seattle Genetics trials were single arm rather than double blind. We'll need to see if that sways FDA opinion as to whether to recommend accelerated approval or not. All signs up till now would point toward the drug receiving the go ahead. If approved, the will be Seattle Genetics first ever drug and will also be the first ADC approved. See Xconomy.
Posted by Bruce Lehr July 12th 2011.