EC approves Adcetris for CD30-positive cutaneous T-cell lymphoma.

Adcetris (brentuximab vedotin), from Takeda, is also approved for the treatment of adult patients with CD30-positive cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. The decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on November 9, 2017.

This approval is based on data from the randomized, open-label Phase III ALCANZA trial, which demonstrated that single agent Adcetris provided a highly statistically significant improvement in the overall response rate lasting at least four months (ORR4) versus the control arm of methotrexate or bexarotene as assessed by an independent review facility. The ORR4 was 56.3 percent in the Adcetris arm compared to 12.5 percent in the control arm. The study also showed that complete response rate, progression-free survival and reduction in the burden of symptoms during treatment, as measured by the Skindex-29 questionnaire, were all highly statistically significant in favor of the Adcetris arm.

The safety profile associated with Adcetris from the ALCANZA trial was generally consistent with the existing prescribing information. The most common adverse events of any grade include: peripheral neuropathy, nausea, diarrhea, fatigue, vomiting, alopecia, pruritis, pyrexia, decreased appetite and hypertriglyceridemia. In the Adcetris arm, the most common grade 3 or 4 events were peripheral sensory neuropathy (no grade 4 events), fatigue, diarrhea, nausea, vomiting and pruritis. In the control arm, the most common grade 3 or 4 events were hypertriglyceridemia, pruritis, fatigue and pyrexia.

Updated results from the trial were recently presented at the 59th American Society of Hematology (ASH) Annual Meeting in December 2017. Long-term analyses from the ALCANZA trial continue to provide compelling evidence of improved response rates, progression free survival and quality of life with Adcetris vs. the control arm.