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New Hodgkin lymphoma treatment approved in Japan
BOTHELL, Wash.—Seattle Genetics mentioned today that its collaborator, Takeda Pharmaceutical, has gotten approval from the Japanese Ministry of Health, Labour and Welfare for ADCETRIS (brentuximab vedotin) in combination with doxorubicin, vinblastine and dacarbazine (AVD) as a frontline treatment option for CD30-positive Hodgkin lymphoma patients in Japan. As a result, Seattle Genetics will receive a milestone payment from Takeda of $10 million. The approval in Japan was based on positive outcomes from the Phase III ECHELON-1 trial.
“This approval marks another important milestone in expanding the ADCETRIS brand globally and redefining the way newly diagnosed Hodgkin lymphoma patients are treated around the world,” said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “ADCETRIS is approved in 71 countries and generated global sales of approximately $640 million in 2017, underscoring its progress toward becoming the foundation of therapy for patients with CD30-expressing lymphomas.”
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), 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.
Seattle Genetics and Takeda are jointly developing brentuximab vedotin. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and Takeda has rights to commercialize brentuximab vedotin in the rest of the world. Seattle Genetics and Takeda are funding joint development costs for brentuximab vedotin on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs. Seattle Genetics is entitled to receive progress- and sales-dependent milestone payments. In addition, Seattle Genetics receives tiered double-digit royalties with percentages ranging from the mid-teens to mid-twenties, based on net sales of brentuximab vedotin within Takeda’s territories.
ADCETRIS is being evaluated broadly in more than 70 clinical trials, including the ongoing Phase III ECHELON-2 trial in frontline peripheral T-cell lymphomas (also known as mature T-cell lymphoma), the completed Phase III ALCANZA trial in cutaneous T-cell lymphoma (CTCL), and the completed ECHELON-1 trial in previously untreated Hodgkin lymphoma, as well as trials in many additional types of CD30-positive lymphomas.
Brentuximab vedotin injection for intravenous infusion has received FDA approval for five indications in adult patients with: previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with chemotherapy; cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation; cHL after failure of auto-HSCT or failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates; sALCL after failure of at least one prior multi-agent chemotherapy regimen; and primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy.
Health Canada granted brentuximab vedotin approval with conditions for relapsed or refractory Hodgkin lymphoma and sALCL in 2013, and non-conditional approval for post-autologous stem cell transplantation (ASCT) consolidation treatment of Hodgkin lymphoma patients at increased risk of relapse or progression.
Brentuximab vedotin received conditional marketing authorization from the European Commission in October 2012. The approved indications in Europe are: for the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma following ASCT, or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option; the treatment of adult patients with relapsed or refractory sALCL; for the treatment of adult patients with CD30-positive Hodgkin lymphoma at increased risk of relapse or progression following ASCT; and for the treatment of adult patients with CD30-positive cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.
Seattle Genetics develops and commercializes therapies which target cancer. Brentuximab vedotin utilizes the company’s ADC technology and is currently approved for the treatment of multiple CD30-expressing lymphomas. Beyond brentuximab vedotin, the company has established a pipeline of novel targeted therapies at various stages of clinical testing, including three in ongoing pivotal trials for solid tumors. Enfortumab vedotin for metastatic urothelial cancer and tisotumab vedotin for metastatic cervical cancer utilize their proprietary ADC technology. Tucatinib, a small molecule tyrosine kinase inhibitor, is in a pivotal trial for HER2-positive metastatic breast cancer. The company is headquartered in Bothell, Washington, and has a European office in Switzerland.