Takeda Pharmaceuticals Korea announced Tuesday that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has agreed to extend the marketing authorization of Adcetris (ingredient: Brentuximab vedotin).
Adcetris is an antibody-drug conjugate used to treat adult patients with CD30-positive cutaneous T-cell lymphoma (CTCL).
The extension from the EMA panel is based on the results of the randomized, open-label phase 3 Alcanza study designed to evaluate single-agent Adcetris versus a control arm of investigator’s choice of standard of care therapies (methotrexate or bexarotene) in patients with CD30-positive CTCL, the company said.
The trial achieved positive results, and the Adcetris treatment arm demonstrated significant improvement in the overall response rate lasting at least four months (ORR4) versus the control arm as assessed by an independent review facility (p-value <0.0001).
The most common adverse side effects of Adcetris include peripheral neuropathy, nausea, diarrhea, fatigue, vomiting, alopecia, pruritis, pyrexia, decreased appetite, and hypertriglyceridemia.
The decision for Adcetris will be reviewed by the European Commission (EC), which has the authority to approve medicines for use in the 28 countries of the European Union, Norway, Liechtenstein, and Iceland.
Adcetris won approval in Korea in 2013 and 2016 and covers the second-line relapsed or refractory CD30 positive ALCL, second-line relapsed or refractory CD positive Hodgkin lymphoma patients who failed ASCT and third line for patients who are not ASCT candidates.
“Today’s positive opinion is an important milestone for the CTCL community, and further reinforces the role Adcetris may have in improving outcomes for patients with CD30-positive malignancies,” said Jesus Gomez Navarro, vice president of Oncology Clinical Research and Development, Takeda.
He went on to say, “For patients with CTCL, there is a significant need for additional treatment options that increase the opportunity to achieve durable responses. We look forward to the European Commission’s review of the positive opinion of this new indication and the possibility to bring Adcetris to appropriate CTCL patients in the European Union.”
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