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FDA Grants Orphan Drug Designation for Adcetris (Brentuximab Vedotin) in Mycosis Fungoides
Adcetris (brentuximab vedotin, Seattle Genetics) has been granted orphan drug designation by the FDA for the treatment of mycosis fungoides (MF). MF is the most common type of cutaneous T-cell lymphoma (CTCL). The phase III ALCANZA trial is evaluating Adcetris in patients with CD30-positive relapsed CTCL, including MF. Adcetris is not FDA-approved for the treatment of CTCL.
In the ALCANZA trial, Adcetris is being compared with the investigators’ choice of methotrexate or bexarotene in patients with CD30-positive CTCL, including those with primary cutaneous anaplastic large-cell lymphoma (ALCL) or MF. The primary endpoint of the study is the overall response rate lasting at least 4 months. Approximately 124 patients will be enrolled.
Adcetris (brentuximab vedotin) is an antibody–drug conjugate (ADC) consisting of an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule-disrupting agent, monomethyl auristatin E (MMAE). The ADC employs a linker system that is stable in the bloodstream but that releases MMAE upon internalization into CD30-expressing tumor cells.
Adcetris was granted accelerated approval by the FDA in August 2011 for two indications: 1) the treatment of patients with Hodgkin lymphoma after the failure of autologous stem-cell transplantation (ASCT) or after the 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 ALCL after the failure of at least one prior multi-agent chemotherapy regimen. The indications for Adcetris are based on the response rate. No clinical data have demonstrated an improvement in patient-reported outcomes or survival with Adcetris.
MF is the most common subtype of CTCL. CTCLs constitute a group of non-Hodgkin lymphomas (NHLs) and are cancers of T lymphocytes (a type of white blood cell), which mainly affect the skin but can also involve the blood, lymph nodes, and/or internal organs in patients with advanced disease.
According to the Cutaneous Lymphoma Foundation, CTCL is the most common type of cutaneous lymphoma and typically presents with red, scaly patches or thickened plaques of skin that often mimic eczema or chronic dermatitis. Progression from limited skin involvement is variable and may be accompanied by tumor formation, ulceration, and exfoliation complicated by itching and infections. Advanced stages are defined by the involvement of lymph nodes, peripheral blood, and internal organs. According to the published literature, up to 50% of the lesions in CTCL patients express CD30.
Source: Seattle Genetics; November 26, 2012.