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.

The compound is being developed with Takeda and, if approved, would become Seattle Genetics’s first product to come to market in its 14 years of existence. It would be sold in the USA and Canada by Seattle Genetics and elsewhere by development partner Millennium Pharmaceuticals’ parent company Japan’s Takeda (TSE: 4502). The latter drugmaker recently filed for European approval of Adcetris (The Pharma Letter June 28).