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news.Seattle Genetics has received the US Food and Drug Administration (FDA) approval for antibody-drug conjugate (ADC) Adcetris (brentuximab vedotin).
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The drug has been approved for the patients with Hodgkin lymphoma and for the patients suffering from systemic anaplastic large cell lymphoma (ALCL).
The approvals were given on the basis of results from two trials where the primary endpoint of both the trials was overall response rate as assessed by an independent review facility.
Seattle Genetics expects to make Adcetris available to patients next week.
Seattle Genetics president and CEO Clay Siegall said they are committed to continued clinical investigation of Adcetris through a broad development program for CD30-positive malignancies, including confirmatory trials in front-line Hodgkin and T-cell lymphomas that they have planned in consultation with the FDA.