|Seattle Genetics Receives FDA Orphan Drug Designation for ADCETRIS® (Brentuximab Vedotin) in Mycosis Fungoides|
-Designation Supports Regulatory Strategy for ADCETRIS in CTCL, including Ongoing Phase III ALCANZA Trial-
-Investigator Data on ADCETRIS in CTCL to be Presented at Upcoming ASH Annual Meeting-
“This orphan drug designation is a part of our ADCETRIS regulatory
strategy, designed to complement the Special Protocol Assessment for the
ongoing ALCANZA study,” said
The ALCANZA trial is a randomized phase III clinical trial of ADCETRIS
for relapsed CD30-positive CTCL patients. The trial is assessing
ADCETRIS versus investigator’s choice of methotrexate or bexarotene in
patients with CD30-positive CTCL, including those with primary cutaneous
anaplastic large cell lymphoma (pcALCL) or MF. 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. The
ALCANZA trial is being conducted under a Special Protocol Assessment
agreement from the
At the 54th American Society of Hematology (ASH) Annual
Meeting and Exposition being held
Brentuximab vedotin demonstrates significant clinical activity in relapsed or refractory mycosis fungoides with variable CD30 expression (Abstract #797)
Results of a phase II trial of brentuximab vedotin (SGN-35) for CD30-positive cutaneous T-cell lymphomas and lymphoproliferative disorders (Abstract #3688)
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), utilizing Seattle Genetics’ proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells.
ADCETRIS was granted accelerated approval by the
ADCETRIS was granted conditional marketing authorization by the
About Cutaneous T-Cell Lymphoma
Mycosis fungoides is the most common subtype of CTCL. CTCLs constitute a
group of non-Hodgkin lymphomas (NHLs) and are cancers of the T
lymphocytes (a type of white blood cell) that mainly affect the skin but
can also involve the blood, lymph nodes and/or internal organs in
patients with advanced disease. According to the
U.S. Important Safety Information
Progressive multifocal leukoencephalopathy (PML): JC virus infection resulting in PML and death can occur in patients receiving ADCETRIS.
Concomitant use of ADCETRIS and bleomycin is contraindicated due to pulmonary toxicity.
Warnings and Precautions:
ADCETRIS was studied as monotherapy in 160 patients in two phase 2 trials. Across both trials, the most common adverse reactions (≥20%), regardless of causality, were neutropenia, peripheral sensory neuropathy, fatigue, nausea, anemia, upper respiratory tract infection, diarrhea, pyrexia, rash, thrombocytopenia, cough and vomiting.
Patients who are receiving strong CYP3A4 inhibitors concomitantly with ADCETRIS should be closely monitored for adverse reactions.
Certain of the statements made in this press release are forward
looking, such as those, among others, relating to our belief that there
exists clinical evidence for pursuing the approval of ADCETRIS for CTCL.
Actual results or developments may differ materially from those
projected or implied in these forward-looking statements. Factors that
may cause such a difference include risks that data resulting from the
ALCANZA trial with ADCETRIS will not support approvals in any of the
studied indications. More information about the risks and uncertainties