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Supplemental BLA for Adcetris® (brentuximab vedotin) in CTCL granted Priority Review by the FDA
On 16th 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 16th 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.
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