-- Data on use of VELCADE in follicular lymphoma to be featured in additional oral presentation --
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Millennium: The Takeda Oncology Company today announced abstracts from studies involving six molecules in the Company’s portfolio have been accepted for presentation at the annual meeting of the American Society of Hematology (ASH) to be held December 4–7, 2010 in Orlando, Florida. The abstracts include oral presentations across a spectrum of hematologic malignancies.
These data include presentations on VELCADE induction, maintenance and subcutaneous administration in multiple myeloma, as well safety and efficacy in relapsed follicular lymphoma. Other oral presentations will feature Millennium pipeline molecules MLN4924 in acute myeloid leukemia (AML), and brentuximab vedotin (SGN-35) pivotal data in Hodgkin lymphoma (HL) and Phase II results in systemic anaplastic large cell lymphoma (ALCL). Brentuximab vedotin is being developed jointly with Seattle Genetics, Inc. (NASDAQ: SGEN).
“VELCADE research being presented at this year’s ASH meeting further defines its use in multiple myeloma and explores its potential use in relapsed follicular lymphoma,” said Nancy Simonian, M.D., Chief Medical Officer, Millennium. “The data from pipeline molecules MLN4924 and brentuximab vedotin are equally exciting and demonstrate Millennium’s commitment to pioneering new therapies for hematologic malignancies.”
Notable presentations at ASH will include:
- HOVON-65/GMMG-HD4 Randomized Phase III Trial Comparing Bortezomib, Doxorubicin, Dexamethasone (PAD) Vs VAD Followed by High-Dose Melphalan (HDM) and Maintenance with Bortezomib or Thalidomide In Patients with Newly Diagnosed Multiple Myeloma (MM)
- Presenter: Pieter Sonneveld, M.D., University Hospital, Rotterdam, The Netherlands
- Abstract #40: Oral Presentation, Sunday, December 5, 5:15 pm ET
- This Phase III head-to-head, randomized study compared VELCADE maintenance to an immunodulatory agent maintenance in the front-line setting
- Endpoints included progression-free survival, overall survival, response and safety
- Phase 3b UPFRONT Study: Safety and Efficacy of Weekly Bortezomib Maintenance Therapy After Bortezomib-Based Induction Regimens in Elderly, Newly Diagnosed Multiple Myeloma Patients
- Presenter: Ruben Niesvizky, M.D., Weill Cornell Medical College, New York, NY
- Abstract #619: Oral Presentation, Monday, December 6, 2:45 pm ET
- The UPFRONT study is a U.S. community-based, randomized, open-label, multicenter Phase IIIb trial comparing three VELCADE based combinations followed by VELCADE maintenance in front-line multiple myeloma
- Endpoints included profession-free survival, response rate, safety and tolerability
- A Phase 3 Prospective Randomized International Study (MMY-3021) Comparing Subcutaneous and Intravenous Administration of Bortezomib In Patients with Relapsed Multiple Myeloma
- Presenter: Philippe Moreau, University Hospital, Nantes, France
- Abstract #312: Oral Presentation, Monday, December 6, 8:15 am ET
- This multi-center, international, randomized Phase III trial compared intravenous to subcutaneous administration of VELCADE
- Endpoints included response rate, one-year overall survival, duration of response and time to progression
- A Phase 3 Trial Comparing Bortezomib Plus Rituximab with Rituximab Alone In Patients with Relapsed, Rituximab-Naïve or –Sensitive, Follicular Lymphoma
- Presenter: Bertrand Coiffier, M.D., Hospices Civils de Lyon, Pierre-Benite, France
- Abstract #857: Oral Presentation, Monday, December 6, 7:15 pm ET
- A randomized, Phase III, open-label international trial compared VELCADE and rituximab to rituximab alone in relapsed follicular lymphoma
- Endpoints included progression free survival, response rate including complete response, duration of response, time to progression, safety and tolerability
- The Novel, Investigational NEDD8-Activating Enzyme Inhibitor MLN4924 In Adult Patients with Acute Myeloid Leukemia (AML) or High-Grade Myelodysplastic Syndromes (MDS): A Phase 1 Study
- Presenter: Ronan T. Swords, M.D., University of Texas Health Science Center, San Antonio, Texas
- Abstract #658: Oral Presentation, Monday, December 6, 5:15 pm ET
- This is a Phase I, open-label, multi-center study of MLN4924 in two hematologic malignancies
- Endpoints included safety, tolerability, determination of maximum tolerated dose and establishment of Phase II dosing
- Results of a Pivotal Phase 2 Study of Brentuximab Vedotin (SGN-35) in Patients with Relapsed or Refractory Hodgkin Lymphoma
- Presenter: Robert Chen, M.D., City of Hope National Medical Center, Duarte, California
- Abstract #283: Oral Presentation, Monday, December 6, 7:00 am ET
- This pivotal, single-arm, multi-center study examined the efficacy and safety of single-agent brentuximab vedotin in relapsed or refractory post autologous stem cell transplantation Hodgkin lymphoma
- Endpoints included response rate, progression free survival, complete response rate, overall survival and duration of response
- Response assessments by an independent review facility were based on the rigorous and internationally established Revised Response Criteria for Malignant Lymphoma (Cheson, 2007)
- Complete Remissions with Brentuximab Vedotin (SGN-35) in Patients with Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma
- Presenter: Andrei Shustov, M.D., University of Washington Medical Center, Seattle, Washington
- Abstract #961: Oral Presentation, Tuesday, December 7, 7:30 am ET
- A single-arm, Phase II multi-center study to determine efficacy and safety of brentuximab vedotin in patients with relapsed or refractory systemic anaplastic large cell lymphoma
- Endpoints included objective response rate, progression free survival, complete response rate, overall survival and duration of response
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 the Millennium/Seattle Genetics Collaboration
Millennium 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.
VELCADE is co-developed by Millennium and Ortho Biotech Oncology Research & Development, a unit of Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Millennium is responsible for commercialization of VELCADE in the U.S., Janssen-Cilag is responsible for commercialization in Europe and the rest of the world. Takeda Pharmaceutical Company Limited and Janssen Pharmaceutical K.K. entered into a co-promote agreement in May 2010 for VELCADE in Japan. VELCADE is approved in more than 90 countries and has been used to treat more than 160,000 patients worldwide.
Indications and Important Safety Information (Patient)
What is VELCADE® (bortezomib) Used For?
VELCADE is approved for the treatment of patients with multiple myeloma (a cancer of the plasma cells). VELCADE is also approved for the treatment of patients with mantle cell lymphoma (a cancer of lymph nodes) who have already received other treatments.
How is VELCADE administered?
VELCADE is prescribed by a physician experienced in the use of medications to treat cancer. It is administered as an injection into your vein (IV) by a health care professional.
Who Should Not Receive VELCADE?
Before you receive treatment with VELCADE, tell your doctor about all of your medical conditions. You should not receive VELCADE if you are:
- allergic to bortezomib, boron or mannitol
- pregnant or plan to become pregnant
- breastfeeding. Discuss with your doctor when it is safe to restart breastfeeding after finishing your treatment.
The effects of VELCADE in children have not been evaluated.
What are the Possible Side Effects of VELCADE?
VELCADE can cause serious side effects including:
- Neutropenia (low levels of neutrophils, a type of white blood cell) and Thrombocytopenia (low levels of platelets). VELCADE can cause low levels of white blood cells (infection fighting cells) and/or platelets (clot-forming cells). You will have regular blood tests to check your cell counts during your treatment with VELCADE. If the number of these cells is very low, your doctor may change the dose and/or schedule of VELCADE. If your white blood cells become low, you can be at higher risk for infections. Tell your doctor if you develop a fever or believe you have an infection. If platelets become very low, there is an increased risk of bleeding. Your doctor may recommend a platelet transfusion. There have been cases of bleeding in the stomach, bowels and brain during treatment with VELCADE.
- Gastrointestinal Problems. VELCADE treatment can cause nausea, vomiting, diarrhea, and constipation. If your symptoms are severe, your doctor may recommend IV fluids and/or medications.
- Peripheral neuropathy. VELCADE can cause damage to the nerves, a condition called peripheral neuropathy. You may feel muscle weakness, tingling, burning, pain, and loss of feeling in your hands and feet, any of which can be severe. Tell your doctor if you notice any of these symptoms. Your doctor may change the dose and/or schedule of VELCADE or stop it altogether.
- Low blood pressure. VELCADE can cause a drop in blood pressure. Tell your doctor if you have low blood pressure, feel dizzy or feel as though you might faint. If you are taking drugs that lower blood pressure, your medications might need to be adjusted. If you are not drinking enough liquids, your doctor may need to administer IV fluids.
- Heart problems. VELCADE treatment can cause or worsen heart rhythm problems and heart failure. Your doctor may closely monitor you if you have, or are at risk for, heart disease. Tell your doctor if you experience chest pressure or pain, palpitations, swelling of your ankles or feet, or shortness of breath.
- Lung Disorders. There have been reports of lung disorders in patients receiving VELCADE. Some of these events have been fatal. Tell your doctor if you experience any cough, shortness of breath, wheezing or difficulty breathing.
- Liver disease. If you have liver problems, it can be harder for your body to get rid of VELCADE. VELCADE has caused sudden liver failure in patients who were taking many medications or had other serious medical conditions. Symptoms of liver problems include a yellow discoloration of the eyes and skin (jaundice) and changes in liver enzymes measured in blood tests. Your doctor will closely monitor you if you have liver disease. In patients with moderate or severe liver disease, VELCADE should be started at a lower dose. Additional dose adjustments may be made based on your tolerance of the drug.
- Tumor Lysis Syndrome (TLS). TLS can occur with cancer treatments and your doctor will be monitoring blood and urine for any signs of this syndrome. If you develop TLS, your doctor will take appropriate steps to treat it.
- Reversible Posterior Leukoencephalopathy Syndrome (RPLS). There have been reports of a rare, reversible condition involving the brain called RPLS in patients treated with VELCADE. Patients with RPLS can have seizures, high blood pressure, headaches, tiredness, confusion, blindness or other vision problems. VELCADE treatment should be stopped in cases of RPLS.
The most common side effects seen in patients receiving VELCADE include: thrombocytopenia, neutropenia, nausea, peripheral neuropathy, neuralgia (nerve pain), pyrexia (high temperature), diarrhea, anemia, leukopenia (low levels of white blood cells), decreased appetite, fatigue, constipation, vomiting, dehydration, dyspnea (difficulty breathing), cough, asthenia (low energy), insomnia (trouble sleeping), peripheral edema (swelling of the limbs), and headache.
What other information should you discuss with your doctor?
You should also tell your doctor if you:
- have kidney disease. If you are on dialysis, your doctor will administer VELCADE after the dialysis procedure.
- are taking medication for diabetes. VELCADE can affect your blood glucose levels. Your doctor may require close monitoring of your blood glucose levels and change the dose of your diabetes medicine while you are being treated with VELCADE.
- have liver disease.
- are using medicines like ketoconazole (an anti-fungal) and ritonavir (an anti-viral), which will require close monitoring during treatment with VELCADE.
- are using any other medications (including over the counter drugs), herbal or dietary supplements, or holistic treatments.
- develop a rash of any type while receiving VELCADE.
The side effects of VELCADE may impair your ability to drive or operate machinery.
These are not all of the possible side effects with VELCADE. It is important to always contact your doctor if you experience any side effects while on VELCADE. If you have any questions about VELCADE, contact your doctor. Additional information is available on the VELCADE website at www.VELCADE.com.
Please see the full prescribing information for VELCADE including warnings and precautions.
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).
Editors’ Note: This press release is also available under the Media section of the Company’s website at: www.millennium.com/media
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