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|VELCADE® (bortezomib), ADCETRIS® (brentuximab vedotin) and Millennium Pipeline Agents to be Featured at American Society of Hematology Annual Meeting|
− Data on MLN9708, ADCETRIS to be highlighted in multiple oral presentations −
CAMBRIDGE, Mass., November 5, 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 hematological diseases.
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 lymphomas.
“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 CD30-expressing lymphomas.”
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 patients worldwide.
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:
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 www.VELCADE.com
For more information about VELCADE clinical trials, patients and physicians can contact the Millennium Medical Product Information Department at 1-866-VELCADE (1-866-835-2233).
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 2011for 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 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 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.
For additional important safety information, including Boxed WARNING, please see the full U.S. prescribing information for ADCETRIS at http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.ADCETRIS.com&esheet=50310162&lan=en-US&anchor=www.ADCETRIS.com&index=4&md5=07c190a9bc9618d571172991ffd81da1.
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, www.millennium.com.
About TakedaLocated 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.