Takeda announced that it has submitted an application in Japan seeking approval of a partial change to the manufacturing and marketing authorization for ADCETRIS® (generic name: brentuximab vedotin, “ADCETRIS”), a treatment for relapsed or refractory CD30-positive cutaneous T-cell lymphoma (CD30PLC), concerning the indications, dosage and administration of the drug.
The application is based on the results of ALCANZA (C25001), a Phase III overseas clinical trial evaluating the efficacy and safety of ADCETRIS in patients with relapsed or refractory CD30-positive cutaneous T-cell lymphoma (CTCL), and the results of SGN-35-OU, a Phase II investigator-initiated clinical trial in Japan, which evaluated the efficacy and safety of ADCETRIS in Japanese patients.
CD30-positive CTCL is a type of malignant lymphoma that remains a disease with high unmet patient needs. Most of the therapies that are available for CTCL are often inadequate in terms of response rate or duration, so useful treatment options with new mechanisms of action have been very much in demand.
We will continue to pursue treatment options for diseases with high unmet patient needs and thereby make further contributions to this field.
ALCANZA (NCT01578499) is a randomized, open-label, placebo-controlled clinical trial designed to evaluate the efficacy of methotrexate or bexarotene versus ADCETRIS in patients with relapsed or refractory CD30-positive CTCL, including cases of primary cutaneous anaplastic large cell lymphoma (pcALCL) or mycosis fungoides (MF).
SGN-35-OU (UMIN000034205) is a multicenter, Phase II, investigator-initiated clinical trial designed to evaluate the efficacy and safety of ADCETRIS in Japanese patients with relapsed or refractory CD30-positive CTCL. It was conducted as an investigator-initiated clinical trial led by Okayama University Hospital.
ADCETRIS has been approved in more than 70 countries. The Ministry of Health, Labour and Welfare designated ADCETRIS as an orphan drug for CD30-positive Hodgkin lymphoma and anaplastic large cell lymphoma in March 2012. It was launched in April 2014 for the treatment of relapsed or refractory CD30-positive Hodgkin lymphoma and anaplastic large cell lymphoma in adult patients. Subsequently, in September 2018, it was approved for the treatment of untreated CD30-positive Hodgkin’s lymphoma in adult patients. In March 2019, the Japanese Ministry of Health, Labour and Welfare designated ADCETRIS as an orphan drug for the treatment of CD30-positive peripheral T-cell lymphoma, and in December 2019 it was approved for the treatment of CD30-positive peripheral T-cell lymphoma in adult patients.
In December 2019, it was approved for the treatment of relapsed or refractory CD30-positive Hodgkin’s lymphoma and peripheral T-cell lymphoma in pediatric patients, and in May 2022 it was approved for the treatment of untreated CD30-positive Hodgkin lymphoma.
Takeda is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions. For more information, visit https://www.takeda.com.
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