FDA Reviewing Adcetris for Retreatment and Extended Duration Therapy
Seattle Genetics announced that the FDA has accepted its supplemental Biologics License Application (sBLA) for filing for 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). Adcetris is an antibody-drug conjugate (ADC) directed to CD30, a marker of HL and sALCL.
The sBLA submission is based on results from a Phase 2 clinical trial with two treatment arms. One arm evaluated retreatment with Adcetris 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. In the retreatment group, of the 23 evaluable patients who were retreated with Adcetris, 70% (16 of 23) achieved an objective response, including complete remissions and seven partial remissions. Median duration of retreatment objective response was 8.8 months. In the extended duration of treatment group, the overall objective response rate with extended treatment was 88%, including 76% complete remissions and 12% partial responses.
In August 2011, Adcetris was granted accelerated approval by the FDA for relapsed HL and relapsed sALCL. It is not currently approved for retreatment and extended duration beyond 16 cycles of therapy in relapsed HL and sALCL.For more information call (855) 473-2436 or visit www.adcetris.com.