Millennium and Takeda Announce European Conditional Marketing Authorization
for ADCETRIS® (Brentuximab Vedotin)
− Indicated for use in adult patients with relapsed or refractory CD30
positive Hodgkin lymphoma or relapsed or refractory systemic anaplastic large
cell lymphoma –
− First targeted treatment approved for relapsed or refractory CD30 positive
Hodgkin lymphoma in over thirty years^1−
CAMBRIDGE, Mass. & OSAKA, Japan -- October 31, 2012
Millennium: The Takeda Oncology Company and Takeda Pharmaceutical Company
Limited (TSE:4502, “Takeda”), today announced that the European Commission
(EC) has granted conditional marketing authorization for ADCETRIS^®
(brentuximab vedotin) for two indications: (1) the treatment of adult patients
with relapsed or refractory CD30 positive Hodgkin lymphoma (HL) following
autologous stem cell transplant (ASCT) or following at least two prior
therapies when ASCT or multi-agent chemotherapy is not a treatment option, and
(2) for the treatment of adult patients with relapsed or refractory systemic
anaplastic large cell lymphoma (sALCL).
On 19 July 2012, the Committee for Medicinal Products for Human Use (CHMP)
adopted a positive opinion for conditional marketing authorization for
ADCETRIS, based on a positive benefit-risk assessment in the above
indications. Granting of conditional marketing authorization by the EC means
that there are specific obligations to provide additional clinical data at a
later stage to confirm the positive benefit-risk balance.
Takeda intends to launch ADCETRIS across Europe, with the first launches
planned in the coming weeks.
“ADCETRIS has been shown to offer a high overall response rate, including
durable complete responses in both of its indications,” said Professor Andreas
Engert, M.D., University Hospital of Cologne, Germany. “Conditional marketing
authorization by the European Commission signifies an important advancement in
the treatment of adult patients with these rare CD30 positive hematological
cancers who are relapsed or refractory and previously had limited options.”
“The European conditional marketing authorization of ADCETRIS represents a
significant step in Takeda’s oncology franchise commitment to developing
innovative medicines that make a real difference to patients’ lives,” said
Trevor Smith, Head of Commercial Operations, Europe & Canada, Takeda
Pharmaceuticals. “ADCETRIS is a new targeted therapeutic option for adult
patients with relapsed or refractory Hodgkin lymphoma or relapsed or
refractory systemic anaplastic large cell lymphoma, and Takeda looks forward
to making it available in Europe.”
ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining
marker of classical HL and sALCL. The marketing authorisation, which will be
held by Takeda Global Research & Development Centre (Europe) Ltd, is valid in
all EU member states as well as Iceland, Liechtenstein and Norway, and is
based on data from clinical trials and other supportive data in relapsed or
refractory HL and relapsed or refractory sALCL.
A Summary of Product Characteristics will be available on the EMA website
About ADCETRIS^® (Brentuximab Vedotin)
ADCETRIS (brentuximab vedotin) is an antibody-drug conjugate (ADC) comprising
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 designed to be stable in the bloodstream but to
release MMAE upon internalization into CD30-expressing tumor cells.
ADCETRIS was designated as an orphan medicinal product in Europe for both HL
and ALCL by the Committee for Orphan Medicinal Products (COMP) on 15 January
ADCETRIS is a registered trademark of Millennium Pharmaceuticals, Inc.
Millennium: The Takeda Oncology Company and Seattle Genetics are jointly
developing brentuximab vedotin. Under the terms of the collaboration
agreement, Seattle Genetics has U.S. and Canadian commercialization rights and
the Takeda Group has rights to commercialize brentuximab vedotin in the rest
of the world. Seattle Genetics and the Takeda Group are funding joint
development costs for brentuximab vedotin on a 50:50 basis, except in Japan
where the Takeda Group will be solely responsible for development costs.
About Hodgkin Lymphoma
Lymphoma is a general term for a group of cancers that originate in the
lymphatic system. There are two major categories of lymphoma: Hodgkin lymphoma
and non-Hodgkin lymphoma. Hodgkin lymphoma is distinguished from other types
of lymphoma by the presence of one characteristic type of cell, known as the
Reed-Sternberg cell. The Reed-Sternberg cell expresses CD30.
About Anaplastic Large Cell Lymphoma
ALCL is a type of aggressive T-cell lymphoma, comprising about 3 percent of
all non-Hodgkin lymphomas (NHL) in adults and between 10 and 30 percent of all
NHL in children. There are two distinct forms/types of ALCL, including primary
cutaneous ALCL and systemic ALCL (sALCL). sALCL is a clinically aggressive,
systemic lymphoma that primarily involves lymph nodes and expresses CD30.
Millennium: The Takeda Oncology Company, a leading biopharmaceutical company
based in Cambridge, Mass., markets VELCADE, a first-in-class proteasome
inhibitor, and has a robust clinical development pipeline of product
candidates. Millennium Pharmaceuticals, Inc. was acquired by Takeda
Pharmaceutical Company Ltd. in May, 2008. The Company’s research, development
and commercialization activities are focused in oncology. Additional
information about Millennium is available through its website,
About Takeda Pharmaceutical Company Limited
Located in Osaka, Japan, Takeda is a research-based global company with its
main focus on pharmaceuticals. As the largest pharmaceutical company in Japan
and one of the global leaders of the industry, Takeda is committed to strive
towards better health for patients worldwide through leading innovation in
medicine. Additional information about Takeda is available through its
corporate Website, www.takeda.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 pulmonary
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
*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.
^1 Jona A, Younes A. Novel treatment strategies for patients with relapsed
classical Hodgkin lymphoma. Blood Rev. 2010;24:233-238.
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U.S. Media Enquiries:
Lindsay Treadway, +1-617-444-3383
European Media Enquiries:
Takeda Pharmaceuticals International GmbH
Danny Stepto, +44-20-3116-8000
Takeda Pharmaceutical Company Limited
Corporate Communications Dept., +81-3-3278-2037
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