Seattle Genetics, Inc. (SGEN) said it has submitted a supplemental Biologics License Application or sBLA to the U.S. Food and Drug Administration or FDA supporting the usage of ADCETRIS for retreatment and extended duration beyond 16 cycles of therapy in relapsed Hodgkin lymphoma or HL and systemic anaplastic large cell lymphoma or sALCL.
ADCETRIS is an antibody-drug conjugate 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 company noted that the sBLA submission includes data demonstrating ADCETRIS activity in managing HL and sALCL when used in the retreatment setting, as well as beyond the 16 cycles described in its current label, while retaining a manageable safety profile.
The sBLA is based on results from a phase II clinical trial with two treatment arms. One arm evaluated retreatment with ADCETRIS in patients who responded earlier to treatment with ADCETRIS, then discontinued treatment and subsequently had disease progression or relapse, while the other arm allowed treatment extension and assessed prolonged treatment with ADCETRIS beyond 16 cycles of therapy.
Currently, ADCETRIS is not approved for retreatment and extended duration beyond 16 cycles of therapy in relapsed HL and sALCL.
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