U.S. Food and Drug Administration gives unanimous recommendations for accelerated approval of Seattle Genetics' adcetris

Bothell's Seattle Genetics is another step closer to gaining accelerated approval of adcetris, an antibody-drug conjugate that targets cancer cells.

The 13-year-old biotechnology company announced yesterday that the Oncologic Drugs Advisory Committee (ODAC) to the U.S. Food and Drug Administration (FDA) voted 10-0 to recommend that the FDA give the go-ahead for its lead drug, which treats patients with Hodgkin lymphoma who relapse after autologous stem-cell transplant (ASCT).

In addition, 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 Aug. 30 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 recommendations by the ODAC panels today are another significant step forward in our development of adcetris," said Clay B. Siegall, Ph.D., president and chief executive officer of Seattle Genetics, in a press release. "If approved, adcetris would be the first in a new class of ADCs, utilizing stable linkers and potent cytotoxic payloads. We look forward to continuing to interact with the FDA in its evaluation of adcetris towards our goal of bringing this CD30-directed drug to patients in need."

The adcetris BLAs were based primarily on data from a pivotal trial in relapsed or refractory Hodgkin lymphoma that was conducted under a Special Protocol Assessment with the FDA and from a phase II trial in relapsed or refractory systemic ALCL. The FDA is not obligated to follow the guidance of advisory committee panels, but normally takes its advice into consideration before making its final decision on approval.

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