US FDA Advisory Committee gives unanimous backing for Seattle Genetics' Adcetris; another CRL for Transcept's Intermezzo
The US Food and Drug Administration’s Oncologic Drugs Advisory Committee (ODAC) voted 10-0 to recommend that the agency grants accelerated approval of Seattle Genetics (Nasdaq: SGEN) Adcetris (brentuximab vedotin) for the treatment of patients with Hodgkin lymphoma who relapse after autologous stem cell transplant (ASCT).
In addition, the ODAC voted 10-0 to recommend that the FDA grant accelerated approval of Adcetris for the treatment of patients with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL). The FDA is expected to act on the two Biologics License Applications (BLAs) for Adcetris by August 30, 2011 under the Prescription Drug User Fee Act (PDUFA). Adcetris is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of Hodgkin lymphoma and ALCL.
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