Supplemental BLA for Adcetris® (brentuximab vedotin) in CTCL granted Priority Review by the FDA

On 16^th August 2017, the U.S. Food and Drug Administration (FDA) accepted the Supplemental Biologics License Application (sBLA) submitted by Seattle Genetics, Inc., for Adcetris® (brentuximab vedotin) in the treatment of patients with Cutaneous T-Cell Lymphoma (CTCL). Furthermore, the FDA has granted Priority Review of this application with a target action date of 16^th December 2017.

The sBLA is based on data from the phase III ALCANZA trial (NCT01578499), which compared brentuximab vedotin to methotrexate or bexarotene in relapsed/refractory CD30+ CTCL patients. The results of the trial were published in The Lancet in June of this year, which the Lymphoma Hub reported on; read more here. Also, while at this year’s ICML conference, we interviewed Professor Miles Prince from the Peter MacCallum Cancer Center, Melbourne, Australia, on the ALCANZA trial; watch it here.

• Brentuximab vedotin demonstrated a statistically significant improvement in the rate of Objective Response lasting at least four months (ORR4) compared to the control arm as assessed by an independent review facility
• ORR4 assessed by Global Response Score was 56.3% with brentuximab vedotin versus5% with control treatment (P < 0.0001)
• CR, PFS, and reduction in the burden of symptoms during treatment (Skindex-29) were all highly statistically significant in favor of brentuximab vedotin
• The safety profile associated with brentuximab vedotin was largely consistent with the present prescribing information; the most frequently observed AEs of any grade included anemia, peripheral sensory neuropathy, nausea, diarrhea, fatigue, and neutropenia

Additional data from two investigator-sponsored phase II studies were also included in the sBLA. Currently, Adcetris® is not approved by the FDA or the European Medicines Agency (EMA) for CTCL.