Seattle Genetics is celebrating after advisors to the US Food and Drug Administration have recommended accelerated approval of its lymphoma treatment Adcetris.
The agency's Oncologic Drugs Advisory Committee voted 10-0 to recommend that the FDA grant accelerated approval of Adcetris (brentuximab vedotin) for the treatment of patients with Hodgkin's lymphoma who relapse after autologous stem cell transplant. The panel also voted 10-0 in support of giving the green light for the drug in patients with relapsed or refractory systemic anaplastic large cell lymphoma.
Clay Siegall, Seattle Genetics' chief executive, noted that if approved, Adcetris "would be the first in a new class of antibody-drug conjugates, utilising stable linkers and potent cytotoxic payloads". The treatment is targeted to CD30, a defining marker of Hodgkin's.
Under accelerated approval, drugmakers have to conduct follow-up studies to confirm the effectiveness and safety of their treatments, and Seattle Genetics will discuss the structure of these trials with the FDA. A final decision is expected by August 30 and analysts believe Adcetris, for which Takeda holds the rights outside North America, will be a blockbuster.