-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-
BOTHELL, Wash.--(BUSINESS WIRE)--Nov. 26, 2012--
Seattle Genetics, Inc. (Nasdaq: SGEN) announced today that ADCETRIS
(brentuximab vedotin) has been granted orphan drug designation by the
U.S. Food and Drug Administration (FDA) for the treatment of mycosis
fungoides (MF). MF is the most common type of cutaneous T-cell lymphoma
(CTCL). Seattle Genetics and its ADCETRIS collaborator, Millennium: The
Takeda Oncology Company, are conducting the ALCANZA trial, a phase III
clinical trial of ADCETRIS for patients with CD30-positive relapsed
CTCL, including MF. ADCETRIS is not approved for the treatment of CTCL.
“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 Clay B. Siegall, President and Chief
Executive Officer of Seattle Genetics. “The encouraging data from
investigator-sponsored trials of ADCETRIS in CTCL, which will be
presented at ASH, provide further support for our activities in this
FDA orphan drug designation is intended to encourage companies to
develop therapies for the treatment of diseases that affect fewer than
200,000 individuals in the United States. This designation provides
Seattle Genetics with the opportunity for seven years of marketing
exclusivity, grant funding to defray costs of clinical trial expenses,
tax credits for clinical research expenses and potential waiver of the
FDA's application user fee.
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 FDA. The study also received European Medicines
Agency scientific advice. For more information about the ALCANZA trial,
At the 54th American Society of Hematology (ASH) Annual
Meeting and Exposition being held December 8-11, 2012 in Atlanta, GA,
data from two investigator-sponsored trials of ADCETRIS in CTCL will be
Brentuximab vedotin demonstrates significant clinical activity in
relapsed or refractory mycosis fungoides with variable CD30 expression
Oral presentation on Monday, December 10; 7:15 p.m. Eastern Time (ET)
in Rooms B304-B305
First author: Dr. Michael Krathen, Stanford University, Stanford, CA
Results of a phase II trial of brentuximab vedotin (SGN-35) for
CD30-positive cutaneous T-cell lymphomas and lymphoproliferative
disorders (Abstract #3688)
Poster presentation on Monday, December 10; 6:00 p.m. to 8:00 p.m. ET
in Hall B1-B2
First author: Dr. Madeleine Duvic, The University of Texas MD Anderson
Cancer Center, Houston, TX
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 FDA in August 2011 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. The indications for ADCETRIS are
based on response rate. There are no data available demonstrating
improvement in patient-reported outcomes or survival with ADCETRIS.
ADCETRIS was granted conditional marketing authorization by the European
Commission in October 2012 for two indications: (1) the treatment of
patients with Hodgkin lymphoma after failure of 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 sALCL after
failure of at least one prior multi-agent chemotherapy regimen. See
important safety information below.
Seattle Genetics and Millennium are jointly developing ADCETRIS. Under
the terms of the collaboration agreement, Seattle Genetics has U.S. and
Canadian commercialization rights and the Takeda Group has rights to
commercialize ADCETRIS in the rest of the world. Seattle Genetics and
the Takeda Group are funding joint development costs for ADCETRIS on a
50:50 basis, except in Japan where the Takeda Group is solely
responsible for development costs.
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 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 involvement of lymph nodes, peripheral
blood and internal organs. According to published literature, up to 50
percent of CTCL patients’ lesions express CD30.
About Seattle Genetics
Seattle Genetics is a biotechnology company focused on the development
and commercialization of monoclonal antibody-based therapies for the
treatment of cancer. The FDA granted accelerated approval of ADCETRIS in
August 2011 for two indications. ADCETRIS is being developed in
collaboration with Millennium: The Takeda Oncology Company. In addition,
Seattle Genetics has three other clinical-stage ADC programs: SGN-75,
ASG-5ME and ASG-22ME. Seattle Genetics has collaborations for its ADC
technology with a number of leading biotechnology and pharmaceutical
companies, including Abbott, Agensys (an affiliate of Astellas), Bayer,
Celldex Therapeutics, Daiichi Sankyo, Genentech, GlaxoSmithKline,
Millennium, Pfizer and Progenics, as well as ADC co-development
agreements with Agensys and Genmab. More information can be found at www.seattlegenetics.com.
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
Warnings and Precautions:
Peripheral neuropathy: ADCETRIS treatment causes a peripheral
neuropathy that is predominantly sensory. Cases of peripheral motor
neuropathy have also been reported. ADCETRIS-induced peripheral
neuropathy is cumulative. Treating physicians should monitor patients
for symptoms of neuropathy, such as hypoesthesia, hyperesthesia,
paresthesia, discomfort, a burning sensation, neuropathic pain or
weakness and institute dose modifications accordingly.
Infusion reactions: Infusion-related reactions, including anaphylaxis,
have occurred with ADCETRIS. Monitor patients during infusion. If an
infusion reaction occurs, the infusion should be interrupted and
appropriate medical management instituted. If anaphylaxis occurs, the
infusion should be immediately and permanently discontinued and
appropriate medical management instituted.
Neutropenia: Monitor complete blood counts prior to each dose of
ADCETRIS and consider more frequent monitoring for patients with Grade
3 or 4 neutropenia. If Grade 3 or 4 neutropenia develops, manage by
dose delays, reductions or discontinuation. Prolonged (≥1 week) severe
neutropenia can occur with ADCETRIS.
Tumor lysis syndrome: Patients with rapidly proliferating tumor and
high tumor burden are at risk of tumor lysis syndrome and these
patients should be monitored closely and appropriate measures taken.
Progressive multifocal leukoencephalopathy (PML): JC virus infection
resulting in PML and death has been reported in ADCETRIS-treated
patients. In addition to ADCETRIS therapy, other possible contributory
factors include prior therapies and underlying disease that may cause
immunosuppression. Consider the diagnosis of PML in any patient
presenting with new-onset signs and symptoms of central nervous system
abnormalities. Evaluation of PML includes, but is not limited to,
consultation with a neurologist, brain MRI, and lumbar puncture or
brain biopsy. Hold ADCETRIS if PML is suspected and discontinue
ADCETRIS if PML is confirmed.
Stevens-Johnson syndrome: Stevens-Johnson syndrome has been reported
with ADCETRIS. If Stevens-Johnson syndrome occurs, discontinue
ADCETRIS and administer appropriate medical therapy.
Use in pregnancy: Fetal harm can occur. Pregnant women should be
advised of the potential hazard to the fetus.
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.
For additional important safety information, including Boxed WARNING,
please see the full U.S. prescribing information for ADCETRIS at www.seattlegenetics.com
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
faced by Seattle Genetics is contained in the company’s 10-Q for the
quarter ended September 30, 2012 filed with the Securities and Exchange
Commission. Seattle Genetics disclaims any intention or obligation to
update or revise any forward-looking statements, whether as a result of
new information, future events or otherwise.
Source: Seattle Genetics, Inc.
Seattle Genetics, Inc.
Peggy Pinkston, 425-527-4160