VELCADE® (bortezomib), ADCETRIS® (brentuximab vedotin) and Millennium
Pipeline Agents to be Featured at American Society of Hematology Annual
− Data on MLN9708, ADCETRIS to be highlighted in multiple oral presentations −
CAMBRIDGE, Mass. -- November 05, 2012
Millennium: The Takeda Oncology Company with its parent company Takeda
Pharmaceutical Company Limited (TSE:4502) today announced that more than 60
abstracts from studies involving five molecules in the Company’s portfolio
have been accepted for presentation at the annual meeting of the American
Society of Hematology (ASH) being held December 8 – 11 in Atlanta, Georgia.
The abstracts include oral and poster presentations across a range of
Presentations include retreatment and maintenance data on VELCADE in multiple
myeloma (MM). Data on once-weekly MLN9708, the first oral proteasome inhibitor
in clinical trials, will be presented from two studies: the first as part of
an all-oral triplet in previously untreated MM, and the second in relapsed or
refractory light-chain amyloidosis. Additionally, data will be presented on
ADCETRIS in combination with chemotherapy regimens in both previously
untreated Hodgkin lymphoma and previously untreated systemic anaplastic large
cell lymphoma (sALCL) and other CD30-expressing mature T-cell and NK-cell
“The VELCADE and MLN9708 data being presented at ASH further demonstrate
Millennium’s leadership in protein homeostasis,” said Karen Ferrante, M.D.,
Chief Medical Officer, Millennium. “Additionally, the promising ADCETRIS data
serve as the basis for the continued development in earlier lines of
*Meta-analysis of the Efficacy and Safety of Bortezomib Retreatment in
Patients with Multiple Myeloma
*Presenter: Kevin B. Knopf, M.D., MPH, California Pacific Medical
Center, San Francisco, CA
*Abstract #1863: Poster presentation, Saturday, December 8, 5:30-7:30
p.m. ET, Hall B1-B2, Level 1, Building B, Georgia World Congress
*Phase 1 / 2 Study of Weekly MLN9708 an Investigational Oral Proteasome
Inhibitor, in Combination with Lenalidomide and Dexamethasone in Patients
with Previously Untreated Multiple Myeloma
*Presenter: Shaji K. Kumar, M.D., Associate Professor of Hematology
and Medicine, Rochester, MN
*Abstract #332: Oral presentation, Monday, December 10, 7:15 a.m. ET,
Thomas Murphy Ballroom 2-3, Level 5, Building B, Georgia World
*MLN9708, a Novel, Investigational Oral Proteasome Inhibitor, in Patients
with Relapsed or Refractory Light-Chain Amyloidosis (AL): Results of a
Phase 1 Study
*Presenter: Professor Giampaolo Merlini, MD, Amyloidosis Research and
Treatment Center, University of Pavia, Italy
*Abstract #731 : Oral presentation, Monday, December 10, 5:30 p.m. ET,
Thomas Murphy Ballroom 2-3, Level 5, Building B, Georgia World
*Brentuximab Vedotin Administered Concurrently with Multi-Agent
Chemotherapy as Frontline Treatment of ALCL and Other CD30+ Mature T-Cell
and NK-Cell Lymphomas
*Presenter: Michelle Fanale, M.D., University of Texas MD Anderson
Cancer Center, Houston, TX
*Abstract #60: Oral presentation Sunday, December 9, 1:15 p.m. ET,
Sidney Marcus Auditorium, Level 4, Building A, Georgia World Congress
*Frontline Therapy with Brentuximab Vedotin Combined with ABVD or AVD in
Patients with Newly Diagnosed Advanced Stage HL
*Presenter: Stephen M. Ansell, M.D., Ph.D., Medical Oncologist,
*Abstract #798: Oral presentation, Monday, December 10, 6:15 p.m. ET,
B304-B305, Level 3, Building B, Georgia World Congress Center
VELCADE is co-developed by Millennium and Janssen Pharmaceutical Companies.
Millennium is responsible for commercialization of VELCADE in the U.S.;
Janssen Pharmaceutical Companies are responsible for commercialization in
Europe and the rest of the world. Takeda Pharmaceutical Company Limited and
Janssen Pharmaceutical K.K. co-promote VELCADE in Japan. VELCADE is approved
in more than 90 countries and has been used to treat more than 340,000
Important Safety Information
VELCADE^® (bortezomib) is approved for the treatment of patients with multiple
myeloma. VELCADE is also approved for the treatment of patients with mantle
cell lymphoma who have already received at least one prior treatment.
Patients should not receive VELCADE if they are allergic to bortezomib, boron
or mannitol. VELCADE should not be administered intrathecally. Women should
avoid becoming pregnant or breastfeeding while taking VELCADE. Patients with
diabetes may require close monitoring and adjustment of their medication.
VELCADE can cause serious side effects, including:
*Peripheral neuropathy. Nerve problems, which can be severe including
muscle weakness, tingling, burning, pain, or loss of feeling in the hands
*Low blood pressure. A drop in blood pressure resulting in dizziness,
light headedness or fainting.
*Heart problems. Heart rhythm problems and heart failure including
worsening of existing conditions. Symptoms may include chest pressure or
pain, palpitations, swelling of the ankles or feet, or shortness of
*Lung problems, some of which have been fatal. Symptoms include cough,
shortness of breath, wheezing or difficulty breathing.
*Liver problems. Liver failure including a yellow discoloration of the
eyes and skin.
*Posterior reversible encephalopathy syndrome (PRES). a rare, reversible
condition involving the brain. Symptoms may include seizures, high blood
pressure, headaches, tiredness, confusion, blindness, or other vision
*Gastrointestinal problems. Nausea, vomiting, diarrhea and constipation.
*Thrombocytopenia and neutropenia. Lowering the levels of blood cells,
which could result in a higher risk for infections or bleeding.
*Tumor lysis syndrome (TLS). TLS is a syndrome that causes a chemical
imbalance in the blood that could lead to heart and/or kidney problems.
Common side effects seen in patients receiving VELCADE include: fever,
decreased appetite, fatigue, rash.
These are not all of the possible side effects with VELCADE. Please see the
full Prescribing Information for VELCADE for a complete list also available at
For more information about VELCADE clinical trials, patients and physicians
can contact the Millennium Medical Product Information Department at
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 received accelerated approval from the U.S. Food and Drug
Administration (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
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 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.
See important safety information below.
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.
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.
For additional important safety information, including Boxed WARNING, please
see the full U.S. prescribing information for ADCETRIS at www.ADCETRIS.com.
Editor’s Note: This press release is also available under the Media section of
the Company’s website at: www.millennium.com/InTheNews.aspx.
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,
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.
Manisha Pai, +1-617-551-7877
David Albaugh, +1-617-444-4456
Takeda Pharmaceutical Company Limited
Corporate Communications Dept. (PR/IR)
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