− First and only targeted CD30 antibody drug conjugate indicated for use in 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 Hodgkin lymphoma in over thirty years −
Zurich, Switzerland and Cambridge, Mass., April 05, 2013 – Takeda Pharmaceuticals International GmbH and Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited (TSE:4502), today announced that Swissmedic, the Swiss Agency for Therapeutic Products, has granted approval for ADCETRIS® (brentuximab vedotin) for two indications: (1) the treatment of patients with relapsed or refractory CD30 positive Hodgkin lymphoma (HL) after autologous stem cell transplant or after a minimum of two previous treatments if a stem cell transplantation is not a treatment option, and (2) for the treatment of patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL). Takeda intends to launch brentuximab vedotin in Switzerland in the coming months.
“Brentuximab vedotin has been shown to offer a high overall response rate, including durable complete responses in both of its indications,” said Emanuele Zucca, M.D., Oncology Institute of Southern Switzerland, Bellinzona, Switzerland. “Approval from Swissmedic signifies an important advancement in the treatment of patients with these rare CD30 positive hematological cancers who are relapsed or refractory and previously had limited options.”
“Takeda is committed to developing innovative medicines that have a potential to make a difference to patients’ lives. The approval of brentuximab vedotin in Switzerland represents an important step for Takeda’s oncology franchise,” said Trevor Smith, Head of Commercial Operations, Europe & Canada, Takeda Pharmaceuticals. “We’ve made significant progress in making brentuximab vedotin available in the EU member states since receiving EMA conditional marketing authorization last October. We now look forward to making ADCETRIS, a CD30 targeted therapeutic option available to patients in Switzerland as soon as possible.”
Brentuximab vedotin is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical HL and sALCL. Swissmedic approval for brentuximab vedotin, which will be held by Takeda Global Research & Development Centre (Europe) Ltd, is based on data from clinical trials and other supportive data in relapsed or refractory HL and relapsed or refractory sALCL.
The European Commission (EC) granted conditional marketing authorisation for brentuximab vedotin for the two similar indications in October 2012.
Notes to Editors
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 internalisation into CD30-expressing tumor cells.
ADCETRIS was designated as an orphan medicinal product in Switzerland for both HL and ALCL by Swissmedic on 9 December 2010.
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 commercialisation rights and the Takeda Group has rights to commercialise 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.IMPORTANT SAFETY INFORMATION
ADCETRIS is contraindicated for patients who are hypersensitive to ADCETRIS. In addition, combined use of bleomycin and ADCETRIS causes pulmonary toxicity, and is contraindicated.
SPECIAL WARNINGS & PRECAUTIONS
Progressive multifocal leukoencephalopathy (PML): John Cunningham virus (JCV) reactivation resulting in PML and death has been reported in patients treated with ADCETRIS. In addition to ADCETRIS therapy, other possible contributory factors include prior therapies and underlying disease that may cause immunosuppression.
Patients should be closely monitored for new or worsening neurological, cognitive, or behavioral signs or symptoms, which may be suggestive of PML. ADCETRIS dosing should be held for any suspected case of PML and should be permanently discontinued if a diagnosis of PML is confirmed.
Serious infections and opportunistic infections: Serious infections such as pneumonia, staphylococcal bacteraemia, and herpes zoster, and opportunistic infections such as Pneumocystis jiroveci pneumonia and oral candidiasis have been reported in patients treated with ADCETRIS. Patients should be carefully monitored during treatment for emergence of possible serious and opportunistic infections.
Infusion-related reactions: Immediate and delayed infusion-related reactions, as well as anaphylaxis, have occurred with ADCETRIS. Patients should be carefully monitored during and after an infusion. If anaphylaxis occurs, administration of ADCETRIS should be immediately and permanently discontinued and appropriate medical therapy should be administered.
Tumor lysis syndrome (TLS): TLS has been reported with ADCETRIS. Patients with rapidly proliferating tumor and high tumor burden are at risk of TLS. These patients should be monitored closely and managed according to best medical practice.
Peripheral neuropathy (PN): ADCETRIS treatment may cause PN that is predominantly sensory. Cases of peripheral motor neuropathy have also been reported. ADCETRIS-induced PN is typically cumulative. Patients should be monitored for symptoms of PN, such as hypoesthesia, hyperesthesia, paresthesia, discomfort, a burning sensation, neuropathic pain, or weakness. Dose modification for PN should be instituted accordingly.
Hematological toxicities: Grade 3 or Grade 4 anemia, thrombocytopenia, and prolonged (equal to or greater than one week) Grade 3 or Grade 4 neutropenia can occur with ADCETRIS. Complete blood counts should be monitored prior to administration of each dose.
Febrile neutropenia: Febrile neutropenia has been reported. Patients should be monitored closely for fever and managed according to best medical practice.
Stevens-Johnson syndrome (SJS): SJS has been reported with ADCETRIS. If SJS occurs, treatment with ADCETRIS should be discontinued and appropriate medical therapy should be administered.
Hyperglycemia: Hyperglycemia has been reported during trials in patients with an elevated body mass index (BMI) with or without a history of diabetes mellitus. Patient who experiences an event of hyperglycemia should have their serum glucose closely monitored.
Patients who are receiving strong CYP3A4 inhibitors concomitantly with ADCETRIS should be closely monitored for adverse events..
PREGNANCY: There are no data from the use of ADCETRIS in pregnant women, although studies in animals have shown reproductive toxicity. ADCETRIS should not be used during pregnancy unless the benefit to the mother outweighs the potential risks to the fetus. If a pregnant woman needs to be treated, she should be clearly advised on the potential risk to the fetus.
FERTILITY: In nonclinical studies, ADCETRIS treatment has resulted in testicular toxicity, and may alter male fertility.
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.
About Takeda Pharmaceuticals International GmbH
Takeda Pharmaceuticals International GmbH headquartered in Zurich, is a wholly owned subsidiary of 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, http://www.takeda.com/.
About Millennium: The Takeda Oncology Company
Millennium: The Takeda Oncology Company, a leading biopharmaceutical company based in Cambridge, Mass., was acquired by Takeda Pharmaceutical Company Ltd. in May, 2008. The Company’s research, development and commercialisation activities are focused in oncology. Additional information about Millennium is available through its website, www.millennium.com.
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Jona A, Younes A. Novel treatment strategies for patients with relapsed classical Hodgkin lymphoma. Blood Rev. 2010;24:233-238.