Takeda Pharmaceutical Company Limit announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the extension of the marketing authorization of ADCETRIS® (brentuximab vedotin) and recommended its approval for the treatment of adult patients with CD30-positive cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.
ADCETRIS is an antibody-drug conjugate (ADC) directed at CD30 which is expressed on skin lesions in approximately 50 percent of patients with CTCL. ADCETRIS is currently not approved for the treatment of CTCL.
“This opinion represents a crucial first step forward for European patients living with CTCL, a debilitating disease that can have a significant impact on their quality of life,” said Julia Scarisbrick, M.D., Department of Dermatology, University Hospital Birmingham, Birmingham, UK. “The results of the ALCANZA trial demonstrate impressive efficacy along with a manageable safety profile when compared with methotrexate and bexarotene, commonly used therapies. If approved in Europe, ADCETRIS would offer a novel treatment option for CD30-expressing CTCL patients.”
“Today’s positive CHMP opinion is an important milestone for the CTCL community, and further reinforces the role ADCETRIS may have in improving outcomes for patients with CD30-positive malignancies” said Jesus Gomez Navarro, M.D., Vice President, Head of Oncology Clinical Research and Development, Takeda. “For patients with CTCL, there is a significant need for additional treatment options that increase the opportunity to achieve durable responses. We look forward to the European Commission’s review of the CHMP positive opinion of this new indication and the possibility to bring ADCETRIS to appropriate CTCL patients in the European Union.”
The CHMP positive opinion for ADCETRIS will now be reviewed by the European Commission (EC), which has the authority to approve medicines for use in the 28 countries of the European Union (EU), Norway, Liechtenstein and Iceland.
The positive CHMP opinion is based on the results of the randomized, open-label Phase 3 ALCANZA study designed to evaluate single-agent ADCETRIS versus a control arm of investigator’s choice of standard of care therapies (methotrexate or bexarotene) in patients with CD30-positive CTCL. The trial achieved its primary endpoint and the ADCETRIS treatment arm demonstrated a highly statistically significant improvement in the overall response rate lasting at least four months (ORR4) versus the control arm as assessed by an independent review facility (p-value <0.0001). The ORR4 was 56.3 percent in the ADCETRIS arm compared to 12.5 percent in the control arm. The key secondary endpoints specified in the protocol, including complete response rate, progression-free survival and reduction in the burden of symptoms during treatment, as measured by the Skindex-29 questionnaire1, were all highly statistically significant in favor of the ADCETRIS arm. The safety profile associated with ADCETRIS from the ALCANZA trial was generally consistent with the existing prescribing information. The most common adverse events of any grade include: peripheral neuropathy, nausea, diarrhea, fatigue, vomiting, alopecia, pruritis, pyrexia, decreased appetite and hypertriglyceridemia. In the ADCETRIS arm, the most common grade 3 or 4 events were peripheral sensory neuropathy (no grade 4 events), fatigue, diarrhea, nausea, vomiting and pruritis. In the control arm, the most common grade 3 or 4 events were hypertriglyceridemia, pruritis, fatigue and pyrexia.
About CTCL
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. Cutaneous lymphomas are a category of non-Hodgkin lymphoma that primarily involve the skin. According to the Cutaneous Lymphoma Foundation, CTCL is the most common type of cutaneous lymphoma and typically presents with red, scaly patches or thickened plaques of skin that often mimics eczema or chronic dermatitis. Progression from limited skin involvement may be accompanied by skin tumor formation, ulceration and exfoliation, complicated by itching and infections. Advanced stages are defined by involvement of lymph nodes, peripheral blood and internal organs. According to published literature, CD30 is expressed on CTCL lesions in approximately 50 percent of patients with the disease.
The standard treatment for CTCL includes skin-directed therapies, radiation and systemic therapies or a combination of these. The systemic therapies currently approved for treatment have demonstrated 30 to 45 percent objective response rates, with low complete response rates.
About Takeda Pharmaceutical Company
Takeda Pharmaceutical Company Limited is a global, research and development-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its R&D efforts on oncology, gastroenterology and central nervous system therapeutic areas plus vaccines. Takeda conducts R&D both internally and with partners to stay at the leading edge of innovation. New innovative products, especially in oncology and gastroenterology, as well as our presence in Emerging Markets, fuel the growth of Takeda. More than 30,000 Takeda employees are committed to improving quality of life for patients, working with our partners in health care in more than 70 countries.
Additional information about Takeda is available through its corporate website, www.takeda.com and additional information about Takeda Oncology, the brand for the global oncology business unit of Takeda Pharmaceutical Company Limited, is available through its website, www.takedaoncology.com
Contacts
Japanese Media
Tsuyoshi Tada
tsuyoshi.tada@takeda.com
+81 (0) 3-3278-2417
European Media
Kate Burd
kate.burd@takeda.com
+41 79 514 9533
Media outside Japan/EU
Sara Noonan
sara.noonan@takeda.com
+1-617-551-3683
