Euroopan lääkevirasto (EMA) on myöntänyt ADCETRIS -valmisteelle (brentuksimabivedotiini) käyttöalueen laajennuksen CD30-positiivista Hodgkinin lymfoomaa sairastavien aikuispotilaiden hoitoon tilanteissa, joissa taudin uusiutumisen tai etenemisen riski autologisen kantasolusiirron jälkeen on suurentunut. Tämä käyttöalueen laajennus perustuu faasin 3 AETHERA -tutkimukseen, joka osoitti ADCETRIS -hoidon pidentävän 75 % Hodgkinin lymfoomaa sairastavien potilaiden etenemisvapaata elossaoloaikaa konsolidaatiohoitona autologisen kantasolusiirron jälkeen verrattuna lumelääkehoitoon. Tämä indikaatiolaajennus perustuu EMA:n ihmislääkekomitean (Committee for Medicinal Products for Human Use, CHMP) toukokuussa 2016 antamaan positiiviseen lausuntoon.
Takeda Receives European Commission Approval for the Expanded Use of ADCETRIS®(brentuximab vedotin) as Consolidation Treatment in Post-Transplant Hodgkin Lymphoma
Cambridge, Mass. and Osaka, Japan, July 6th 2016 – Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that the European Commission (EC) has extended the current conditional marketing authorization of ADCETRIS® (brentuximab vedotin) and approved ADCETRIS for the treatment of adult patients with CD30+ Hodgkin lymphoma at increased risk of relapse or progression following autologous stem cell transplant (ASCT). The decision follows a positive opinion from the Committee for Medicinal Products for Human Use on May 26, 2016.
“Relapse is a devastating event for patients with Hodgkin lymphoma and their families. Not only is the emotional impact significant, but the challenge of treating their disease becomes much greater,” said Professor Andreas Engert, M.D., University Hospital of Cologne, Germany. “For the first time, physicians in the European Union will now have a well-tolerated and effective treatment option that may be used immediately post-transplant to reduce the risk of relapse for Hodgkin lymphoma patients at increased risk.”
The AETHERA trial is the first completed randomized study that has explored consolidation treatment immediately following ASCT as a way of extending the effect of transplant for prevention of relapse among people with Hodgkin lymphoma.
“The AETHERA Phase 3 data further reinforces the role of ADCETRIS in earlier line treatment and may offer new hope for post-transplant Hodgkin lymphoma patients,” said Dirk Huebner, M.D., Executive Medical Director, Oncology Therapeutic Area Unit, Takeda Pharmaceutical Company. “The European Commission decision is a significant milestone for patients who are at increased risk of relapse following stem-cell transplant as ADCETRIS provides a treatment where none currently exists.”
The AETHERA trial demonstrated that patients with Hodgkin lymphoma who received ADCETRIS (plus best supportive care) as consolidation therapy immediately following ASCT lived significantly longer without disease progression compared to patients who received placebo (plus best supportive care) as assessed by an independent review committee (hazard ratio=0.57; p-value=0.001), which equates to a 75 percent improvement in PFS. PFS was assessed after a minimum of two years post initiation of treatment for all study patients. An updated analysis conducted after three years of follow up showed sustained PFS improvement (per independent review committee; HR=0.58; 95%CI (0.41,0.81)). A pre-specified interim analysis of overall survival showed no statistically significant difference between the treatment arms.
In January 2016, the EC also approved a Type II variation for ADCETRIS to include data on the retreatment of adult patients with relapsed or refractory (R/R) Hodgkin lymphoma or R/R systemic anaplastic large cell lymphoma (sALCL) who previously responded to ADCETRIS and who later relapsed. Additionally, ADCETRIS five year post-treatment follow up data was presented at the American Society of Hematology (ASH) annual meeting in Orlando, FL, 2015. This demonstrated that the estimated five-year overall survival (OS) rate among ADCETRIS-treated relapsed or refractory HL patients following ASCT was 41 percent (95% CI: 31%, 51%); median OS was 40.5 months (95% CI: 28.7, 61.9 [range 1.8 to 72.9+]) and median progression-free survival (PFS) was 9.3 months (95% CI: 7.1 to 12.2 months).
The most common adverse reactions (≥1/10) seen across all trials for ADCETRIS were infection, upper respiratory tract infection, neutropenia, peripheral neuropathy (sensory and motor), cough, dyspnea, diarrhea, nausea, vomiting, constipation, abdominal pain, alopecia, pruritus, myalgia, arthralgia, fatigue, chills, pyrexia, infusion-related reactions and weight decrease. The safety profile of ADCETRIS in the AETHERA trial was generally consistent with the existing prescribing information.
This decision by the European Commission means that ADCETRIS is now approved for marketing of this indication in the 28 member states of the European Union, Norway, Liechtenstein and Iceland.
For further details about the European Commission decision, please visit the European Medicines Agency website: www.ema.europe.eu/ema.
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.
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 proprietary technology by Seattle Genetics. 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 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 Hodgkin lymphoma 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 systemic anaplastic large cell lymphoma (sALCL). In January 2016, the European Commission approved a Type II variation to include data on the retreatment of adult patients with Hodgkin lymphoma or sALCL who previously responded to ADCETRIS and who later relapse. ADCETRIS has received marketing authorization by regulatory authorities in more than 60 countries.
ADCETRIS is being evaluated broadly in more than 45 ongoing clinical trials, including the Phase 3 ALCANZA trial in CD30+ cutaneous T cell lymphoma (CTCL) and two additional Phase 3 studies, one in frontline classical Hodgkin lymphoma (ECHELON-1) and one in frontline CD30+ mature T-cell lymphomas (ECHELON-2), as well as trials in many additional types of CD30-expressing malignancies.
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 is solely responsible for development costs.
About Takeda Pharmaceutical Company
Takeda Pharmaceutical Company Limited is a global, R&D-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its research efforts on oncology, gastroenterology and central nervous system therapeutic areas. It also has specific development programs in specialty cardiovascular diseases as well as late-stage candidates for 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 its 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. For more information, visit http://www.takeda.com/news.
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.
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