Seattle Genetics files Adcetris at FDA for extended use in Hodgkin Lymphoma and sALCL
Seattle Genetics, Inc. has announced that the FDA has accepted for filing a supplement to the Biologics License Application (sBLA) supporting the use of Adcetris (brentuximab vedotin) for retreatment and extended duration beyond 16 cycles of therapy in relapsed Hodgkin Lymphoma (HL) and Systemic Anaplastic Large Cell Lymphoma (sALCL). The FDA is expected to take action on the application by September 14, 2013.
Adcetris is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of HL and sALCL, that was granted accelerated approval by the FDA in August 2011 for relapsed HL and relapsed sALCL.
The sBLA is based on results from a phase II clinical trial with two treatment arms. One arm evaluated retreatment with Addcetris in patients who previously responded to treatment with Adcetris, then discontinued treatment and subsequently had disease progression or relapse. The other arm evaluated extended treatment with Adcetris beyond 16 cycles of therapy. The sBLA submission includes updated data sets from this phase II trial.
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