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news.Seattle Genetics has received recommendation from the Oncologic Drugs Advisory Committee (ODAC) of the US Food and Drug Administration (FDA) for the approval of Adcetris (brentuximab vedotin) as a treatment for patients with Hodgkin lymphoma which relapses after autologous stem cell transplant (ASCT).
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The committee has also given 100% vote and recommended the FDA to also approve Adcetris as a treatment for patients with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL).
The company’s filing of the biologics license applications (BLAs) was supported by the 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.
Seattle Genetics president and CEO Clay Siegall said they look forward to continuing to interact with the FDA in its evaluation of Adcetris towards their goal of bringing this CD30-directed drug to patients in need.