FDA Grants Orphan Drug Status to Adcetris for Mycosis Fungoides

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Seattle Genetics announced that Adcetris (brentuximab vedotin) has been granted orphan drug designation by the FDA for the treatment of mycosis fungoides (MF), the most common type of cutaneous T-cell lymphoma (CTCL). Adcetris (brentuximab vedotin) is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE).

Seattle Genetics and its Adcetris collaborator, Millennium, are conducting the ALCANZA trial, a Phase 3 clinical trial of Adcetris for patients with CD30-positive relapsed CTCL, including those with primary cutaneous anaplastic large cell lymphoma (pcALCL) or MF. The trial is assessing Adcetris vs. investigator's choice of methotrexate or bexarotene (Targretin; Eisai). The primary endpoint of the study is overall response rate lasting at least 4 months. Approximately 124 patients will be enrolled in the pivotal trial.

Adcetris is approved for two indications: (1) the treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates, and (2) the treatment of patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen.

For more information call (425) 527-4000 or visit www.seagen.com.

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