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Euroopan komissiolta hyväksyntä ADCETRIS®-valmisteen (brentuksimabivedotiini) käyttöön uusiutunutta tai vaikeahoitoista Hodgkinin lymfoomaa ja systeemistä anaplastista suurisoluista lymfoomaa sairastavien aikuispotilaiden uudelleenhoidossa

1. helmikuuta 2016

– Hyväksyntä perustuu avoimeen faasin 2 monikeskustutkimukseen (SGN 35-006 Part A), jonka tiedot vastaavat ADCETRIS-valmisteen vakiintunutta turvallisuus- ja tehoprofiilia –

Cambridge, Massachusetts ja Osaka, Japani, 22.1.2016 Takeda Pharmaceutical CompanyLimited (TSE:4502) kertoi tänään, että Euroopan komissio on hyväksynyt ADCETRIS®-valmisteen (brentuksimabivedotiini) tyypin II variaation. Tämä käsittelee sellaisten uusiutunutta ja vaikeahoitoista Hodgkinin lymfoomaa tai systeemistä anaplastista suurisoluista lymfoomaa (sALCL) sairastavien potilaiden uudelleenhoitoa, jotka ovat aiemmin saaneet vasteen ADCETRIS-valmisteelle ja joiden tauti uusiutuu myöhemmin. Euroopan komission päätös noudattelee Euroopan lääkeviraston ihmislääkekomitean (CHMP) lokakuussa 2015 antamaa positiivista lausuntoa.

Euroopan komissio myönsi vuonna 2012 ADCETRIS-valmisteelle ehdollisen myyntiluvan uusiutuneen CD30-positiivisen Hodgkinin lymfooman hoitoon autologisen kansasolusiirron (ASCT) jälkeen tai vähintään kahden aiemman hoidon jälkeen, jos autologista kantasolusiirtoa tai useammalla lääkeaineella toteutettavaa sytostaattihoitoa ei voida tehdä, sekä uusiutuneen tai vaikeahoitoisen systeemisen suurisoluisen lymfooman hoitoon.

Variaatiossa päivitetään valmisteyhteenvedon kliinisiä kohtia, mukaan lukien turvallisuutta käsittelevät kohdat. Valmisteyhteenvetoon lisätään tiedot sellaisten aikuispotilaiden uudelleenhoidosta, jotka ovat saaneet vasteen aiempaan ADCETRIS-hoitoon (täydellinen tai osittainen vaste) yllä mainittujen käyttöaiheiden mukaisesti, mutta tauti on uusiutunut myöhemmin.

Tyypin II variaatio perustuu faasin 2 (SGN35-006 Part A) tutkimuksen tietoihin, jotka osoittivat, että suurin osa uusiutunutta tai vaikeahoitoista Hodgkinin lymfoomaa ja systeemistä anaplastista suurisoluista lymfoomaa sairastavista potilaista voi saada tehokkaan antituumorivasteen ADCETRIS-uudelleenhoidolla. Tämän tutkimuksen turvallisuus- ja tehotiedot vastasivat keskeisten faasin 2 tutkimusten (SGN35-003 ja SGN35-004) positiivista profiilia.

“ADCETRIS on muuttanut perin pohjin uusiutuneen tai vaikeahoitoisen Hodgkinin lymfooman ja systeemisen anaplastisen suurisoluisen lymfooman hoitokäytänteitä Euroopassa ja siitä on tullut erittäin arvokas keino remission aikaansaamiseksi. Lymfooma on kuitenkin armoton sairaus, ja joillakin näistä hyvin vaikeahoitoisista potilaista tauti uusiutuu. Nyt kun uudelleenhoito on mahdollista, voimme tarjota näille potilaille, joilla on hyvin vähän vaihtoehtoja, uuden mahdollisuuden hyötyä ADCETRIS-hoidosta”, sanoo tohtori Anton Hagenbeek (M.D., Ph.D,), joka toimii hematologian professorina Amsterdamin yliopiston Academic Medical Center -keskuksen hematologian osastolla.

“Euroopan komission päätös ottaa uudelleenhoito mukaan ADCETRIS-valmisteen tuotetietoihin on tärkeä edistysaskel näiden sairauksien kanssa kamppailevien potilaiden hoidossa”, sanoo tohtori, Executive Medical Director Dirk Huebner Takedalta. “Odotamme, että pääsemme jatkamaan käynnissä olevaa ADCETRIS-valmisteen kliinistä tutkimusohjelmaa sekä Hodgkinin lymfooman ja systeemisen anaplastisen suurisoluisen lymfooman että joidenkin muiden lymfoomamuotojen hoidossa. Tavoitteenamme on tuoda tämä tärkeä hoito niille potilaille, jotka saattavat hyötyä siitä.”

Lisätietoja Euroopan komission päätöksestä Euroopan lääkeviraston (EMA) verkkosivulta www.ema.europa.eu/ema.

SGN35-006 Part A -tutkimus

SGN35-006 Part A -tutkimus, jonka nimi on “SGN-35-hoito potilailla, jotka sairastavat CD30-positiivisia hematologisia pahanlaatuisia sairauksia ja jotka ovat aiemmin osallistuneet SGN-35-tutkimukseen”, oli avoin faasin 2 monikeskustutkimus. Tutkimuksessa arvioitiin sellaisten potilaiden uudelleenhoitoa ADCETRIS-valmisteella, jotka sairastavat Hodgkinin lymfoomaa (20 potilasta) tai systeemistä anaplastista suurisoluista lymfoomaa (8 potilasta), joka oli uusiutunut aiemman ADCETRIS-hoitovasteen jälkeen (Part A). Ensisijaiset tavoitteet olivat turvallisuus ja antituumorivaste. Toissijaisena tavoitteena oli tuumorikontrollin kesto, mukaan lukien vasteen ja tautivapaan elinajan (PFS) kesto, kokonaiselossaolo (OS) ja lääkevasta-aineiden (ATA) ilmaantuvuus.

Lisätietoja tutkimuksesta verkkosivulta www.clinicaltrialsregister.eu.


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

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 ADCETRIS

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 autologous stem cell transplant (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. See important safety information below.

ADCETRIS is being evaluated broadly in more than 45 ongoing clinical trials, including the Phase 3 ALCANZA trial and two additional Phase 3 studies, one in frontline classical Hodgkin lymphoma and one in frontline mature T-cell lymphomas, as well as trials in many additional types of CD30-expressing malignancies, including B-cell lymphomas.

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 Located in Osaka, Japan, Takeda (TSE: 4502) 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 people worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, www.takeda.com.

ADCETRIS Global Important Safety Information

ADCETRIS® is indicated for the treatment of adult patients with relapsed or refractory (r/r) CD30+ Hodgkin lymphoma:

  1. Following autologous stem cell transplant or
  2. Following at least 2 prior therapies when autologous stem cell transplantation is not a treatment option

ADCETRIS is indicated for the treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL).

ADCETRIS is contraindicated for patients who are hypersensitive to ADCETRIS. In addition, combined use of bleomycin and ADCETRIS causes pulmonary toxicity, and is contraindicated.

ADCETRIS can cause serious side effects, including:

  • Progressive multifocal leukoencephalopathy (PML): John Cunningham virus (JCV) reactivation resulting in PML and death has been reported in patients treated with ADCETRIS. Patients should be closely monitored for new or worsening neurological, cognitive, or behavioral signs or symptoms, which may be suggestive of PML.
  • Pancreatitis: Acute pancreatitis has been observed in patients treated with ADCETRIS. Fatal outcomes have been reported. Patients should be closely monitored for new or worsening abdominal pain.
  • Pulmonary Toxicity: Cases of pulmonary toxicity have been reported in patients receiving ADCETRIS. In the event of new or worsening pulmonary symptoms (e.g., cough, dyspnoea), a prompt diagnostic evaluation should be performed.
  • Serious infections and opportunistic infections: Serious infections such as pneumonia, staphylococcal bacteraemia, sepsis/septic shock (including fatal outcomes), 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.
  • Tumor lysis syndrome (TLS): TLS has been reported with ADCETRIS. Patients with rapidly proliferating tumor and high tumor burden are at risk of TLS and 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. Patients should be monitored for symptoms of PN, such as hypoesthesia, hyperesthesia, paresthesia, discomfort, a burning sensation, neuropathic pain, or weakness.
  • 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) and Toxic Epidermal Necrolysis (TEN): SJS and TEN have been reported. Fatal outcomes have been reported.
  • Hyperglycemia: Hyperglycemia has been reported during trials in patients with an elevated body mass index (BMI) with or without a history of diabetes mellitus. Any patient who experiences an event of hyperglycemia should have their serum glucose closely monitored.
  • Renal and hepatic impairmentThere is limited experience in patients with renal and hepatic impairment. Population pharmacokinetic analysis indicated that MMAE clearance might be affected by moderate and severe renal impairment, and by low serum albumin concentrations. Elevations in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) have been reported. Liver function should be routinely monitored in patients receiving brentuximab vedotin.
  • Sodium content in excipients: This medicinal product contains a maximum of 2.1 mmol (or 47mg) of sodium per dose. To be taken into consideration for patients on a controlled sodium diet.

Serious adverse drug reactions were: neutropenia, thrombocytopenia, constipation, diarrhea, vomiting, pyrexia, peripheral motor neuropathy and peripheral sensory neuropathy, hyperglycemia, demyelinating polyneuropathy, tumor lysis syndrome, and Stevens-Johnson syndrome.

ADCETRIS was studied as monotherapy in 160 patients in two Phase 2 studies. Across both studies, adverse reactions defined as very common (≥1/10) were: infections, neutropenia, peripheral sensory neuropathy, diarrhea, nausea, vomiting, alopecia, pruritis, myalgia, fatigue, pyrexia, and infusion-related reactions. Adverse reactions defined as common (≥1/100 to <1/10) were: upper respiratory tract infection, herpes zoster, pneumonia, anemia, thrombocytopenia, hyperglycemia, peripheral motor neuropathy, dizziness, demyelinating polyneuropathy, cough, dyspnea, constipation, rash, arthralgia, back pain, and chills.

These are not all of the possible side effects with ADCETRIS. Please refer to Summary of Product Characteristics (SmPC) before prescribing.

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