Cambridge, Mass., November 6, 2014 and Osaka, Japan, November 7, 2014 – Takeda Pharmaceutical Company Limited (TSE:4502) today announced that abstracts of interest from studies on VELCADE® (bortezomib), ADCETRIS® (brentuximab vedotin) and the investigational oral proteasome inhibitor, ixazomib (MLN9708), are among those that have been accepted for presentation at this year’s American Society of Hematology (ASH) annual meeting to be held December 6-9, 2014 in San Francisco, California.
Data selected for presentation include results from the Phase 3 AETHERA clinical trial evaluating the potential treatment of brentuximab vedotin, a CD30-targeted antibody drug conjugate (ADC), as consolidation therapy immediately following an autologous stem cell transplantation (ASCT) in patients with Hodgkin lymphoma at high risk of relapse or progression. Other presentations will feature long-term (four-year) survival data for ADCETRIS in relapsed or refractory systemic Anaplastic Large Cell Lymphoma (sALCL) and results from a Phase 2 study examining long-term maintenance therapy with oral proteasome inhibitor ixazomib for patients with previously untreated multiple myeloma (MM).
“The data to be presented at this year’s ASH highlight the excellent progress we have made in developing our oncology portfolio. The rapid advancement of the ixazomib program over the last five years underscores the potential of this investigational therapy in extending the power of proteasome inhibition,” said Christophe Bianchi, M.D., President, Global Oncology Business Unit, Takeda. “As ADCETRIS continues to expand its reach across the globe and demonstrate the potential for benefit in new indications, and VELCADE is featured in more than 120 presentations, we are excited about our programs and our continued pursuit to improve the care of patients who currently have limited treatment options.”
“The treatment landscapes for patients with both relapsed or refractory Hodgkin lymphoma as well as patients with systemic Anaplastic Large Cell Lymphoma continue to evolve, and the data to be presented at ASH suggest that ADCETRIS could be an important, and potentially paradigm-changing therapy, for these patients,” said Michael Vasconcelles, M.D., Head, Oncology Therapeutic Area Unit, Takeda. “Further, the ixazomib data to be presented advance our understanding of the established and important role of proteasome inhibition in the treatment of multiple myeloma, and provides useful insight into the long-term management of patients with previously untreated multiple myeloma.”
Takeda’s abstracts of interest at ASH 2014 include:
VELCADE® (bortezomib) is co-developed by Millennium/Takeda 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 550,000 patients worldwide.
VELCADE: 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 available at VELCADE.com.
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 for intravenous injection received accelerated approval from the U.S. Food and Drug Administration and approval with conditions from Health Canada for two indications: (1) the treatment of patients with HL 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. 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) for the treatment of adult patients with relapsed or refractory CD30-positive HL following ASCT, or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, and (2) the treatment of adult patients with relapsed or refractory sALCL. ADCETRIS has received marketing authorization by regulatory authorities in 45 countries. See important safety information below.
Seattle Genetics and Takeda are jointly developing ADCETRIS. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and Takeda has rights to commercialize ADCETRIS in the rest of the world. Seattle Genetics and Takeda are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda will be solely responsible for development costs.
ADCETRIS 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.
Concomitant use of strong CYP3A4 inhibitors or inducers, or P-gp inhibitors, has the potential to affect the exposure to MMAE.
Use in Specific Populations:
MMAE exposure is increased in patients with hepatic impairment and severe renal impairment. Closely monitor these patients for adverse reactions.
ADCETRIS Global Important Safety Information
ADCETRIS® is indicated for the treatment of adult patients with relapsed or refractory (r/r) CD30+ Hodgkin lymphoma (HL):
ADCETRIS is indicated for the treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL).
ADCETRIS is contraindicated for patients who are hypersensitive to ADCETRIS. In addition, combined use of bleomycin and ADCETRIS causes pulmonary toxicity, and is contraindicated.
ADCETRIS can cause serious side effects, including:
Serious adverse drug reactions were: neutropenia, thrombocytopenia, constipation, diarrhea, vomiting, pyrexia, peripheral motor neuropathy and peripheral sensory neuropathy, hyperglycemia, demyelinating polyneuropathy, tumor lysis syndrome, and Stevens-Johnson syndrome.
ADCETRIS was studied as monotherapy in 160 patients in two Phase 2 studies. Across both studies, adverse reactions defined as very common (≥1/10) were: infections, neutropenia, peripheral sensory neuropathy, diarrhea, nausea, vomiting, alopecia, pruritis, myalgia, fatigue, pyrexia, and infusion-related reactions. Adverse reactions defined as common (≥1/100 to < 1/10) were: upper respiratory tract infection, herpes zoster, pneumonia, anemia, thrombocytopenia, hyperglycemia, peripheral motor neuropathy, dizziness, demyelinating polyneuropathy, cough, dyspnea, constipation, rash, arthralgia, back pain, and chills.
These are not all of the possible side effects with ADCETRIS. Please refer to Summary of Product Characteristics (SmPC) before prescribing.
Ixazomib is an investigational oral, proteasome inhibitor, which is being studied in multiple myeloma and other malignancies. It is the first oral proteasome inhibitor to enter Phase 3 clinical trials. Four global Phase 3 trials are ongoing; TOURMALINE-MM1, investigating ixazomib in combination with lenalidomide and dexamethasone in relapsed and/or refractory MM, TOURMALINE-MM2, investigating ixazomib in combination with lenalidomide and dexamethasone in patients with newly diagnosed MM, TOURMALINE-MM3, investigating ixazomib as maintenance therapy in patients with newly diagnosed MM following induction therapy and autologous stem cell transplant and TOURMALINE-AL1, investigating ixazomib plus dexamethasone in patients with relapsed or refractory light chain amyloidosis (AL). For additional information on the ongoing Phase 3 studies please visit www.tourmalinetrials.com or www.clinicaltrials.gov.
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 people worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, www.takeda.com.
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