אדסטריס 50 מ"ג - Adcetris 50 mg
| ק×××¦× ×¤×¨×ק×××××ת (ATC4) | L01FX Other monoclonal antibodies and antibody drug conjugates | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| ×ר××× ×¤×¢×× (ATC5) | Â
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| צ×רת ××ª× | ת××-×ר××× - I.V | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| צ×רת ××× ×× | ×××§× ×××× ×ª ת×××¡× ×ר×××ת ××¢×ר××, POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION ××× ×עת ××× ×× ×תר ×× ×רע×× ×ש ××××× ×ת ×תר××¤× ××ת×× ×××× ×× ××××××¥ ××¤× ×©××פ××¢ ××¢××× ×צר×× | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| ×ת×××× | ADCETRIS is indicated for the treatment of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma (HL): 1. following autologous stem cell transplant (ASCT) or 2. following at least two prior therapies when ASCT or multi-agent chemotherapy 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 indicated for the treatment of adult patients with CD30+ HL at increased risk of relapse or progression following ASCT. ADCETRIS is indicated for the treatment of adult patients with CD30+ cutaneous T-cell lymphoma (CTCL) after at least 1 prior systemic therapy . ADCETRIS is indicated for the treatment of adult patients with previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vinblastine, and dacarbazine.ADCETRIS is indicated for the treatment of adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| ×¢××× ×ר××¤× ××××ר×ת ××¢××× |
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| ×¢××× ×צר×× |  |
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| ער××× ××××ק×רפ××× | ער××× ×§×©×ר×× ××××ק×רפ××× |
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| ××ס×ר×ס 50 ×"× ××××ר ××©×¨× ××ר×××ת |
| ××פ×ש ×××ר×× | ×××ר×× ×-PubMed |
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| ××××¢ ×רשת | RxList WebMD Drugs.com |
| ×©× ××¦×¨× | TAKEDA PHARMA A/S, DENMARK |
| ×©× ××¢× ×ר×ש×× | TAKEDA ISRAEL LTD |
| ר×ש××× | ת×ר×× ××ש×: 8/2013. ר×ש××× ×ת×ר××: |
| ת×ר×× ×¢×××× ××ר×× | 25/02/2016 |
- ××ס×ר×ס ק××× ×ת ××ש×ר ××©×¨× ××ר×××ת ××ר××ת ××ת×××× ×××פ×× ×××××× ××××ר××, ×ס××××× ×××××'ק×× ×××פ××× (CD30+) ××× ×צ××× ×ס×××× ×××× ××××©× ×ת ×× ×תק×××ת ××××× ×××ר ×שת×ת ×× ×¢×¦× ×¢×¦××ת.
×× ×סף ××ס×ר×ס ×××שרת ×××פ×× ×××××× ××××ר××, ×ס××××× ×××××'ק×× ×××פ××× (CD30+) × ×©× ×ת ×× ×¢××××: ×××ר ×שת×ת ת×× ×××¢ עצ××ת ( ASCT) ×× ×××ר ×©× × ××פ×××× ×§××××× ×פ××ת, ××שר ASCT ×× ×ש×× ×××××ª×¨×¤× × ×סף ×× ×××××× ××פצ×× ××פ×××ת ××××פ×× ×anaplastic large cell lymphoma ס×ס×××ת × ×©× ×ת ×× ×¢×××× ×××××ר××.
××פ×× ×§×× ×¡××××צ×× ××ק×× ×××ר ×שת×ת ת×× ×××¢ ××××××××ת ××¢×רת ×תר××¤× ×©×פר ×ת ×××שר××ת ××× ×תק×××ת ××ש×××× ×פ×ס×× ××××× HL ×¢× ××ר×× ×¡×××× ××××¨× ×× ×תק×××ת ×××ר ××שת××.
××פ×× ×××× ×× ×××× ××שת×ת ת×× ×××¢ עצ××ת (autologous stem-cell transplantation, ASCT) ××× ×××פ×× ×ס×× ×ר×× ××××× ×××פ××× ×¢"ש ××××'ק×× (Hodgkinâs lymphoma, HL) ×××רת ×× ×¢×××× ×¨×ש×× ×ת (primary refractory). ××¢×× ×©×50% ××××××× × ×¨×¤××× ×××ר ASCT, ×ר××ת ××× ×¢× ××ר×× ×¡×××× ×©×××××× ×××ר×ר×× ×××ר ××שת××. × ×ס×× ×§××× × ×©×× 3, ×קר××, ×פ××-ס×××ת, ר×-×ר××× ××××קר-פ×ס××, שפ××¨×¡× ××תר ××ª× ×עת The Lancet, ××קש ××××× ×ת ×ת××¢×ת ×brentuximab vedotin (Adcetris, Takeda) ×××פ×× ××צ×ק (consolidation) ××ק×× ×××ר ASCT ×ש×פ×ר ×××שר××ת ××× ×תק×××ת (progression-free survival, PFS).
××©×ª×ª×¤× ×× ×ס×× ×××ר×× ××ק×צ×× ×§×××¢×× (fixed-block randomization), ת×× ×¨×××× ××¤× ×ת×××× ×ק××× ×ת ××××× ×××תר ×××ר ×ש××ת ××פ×× ××צ×× ××××××ª×¨×¤× (ת×××× ××××, ת×××× ××ק×ת ×× ×××× ×צ×××) ×××¤× ×××× ××××× (HL ×××רת ×ת×× ×©× × ××ש××ת ×××פ×× ××¢××ת ×××× ×¢×××× ×¨×ש×× ×ת) ×××××¤× ×פ×× ×¡×××ת. ×¡× ××× ×××ר×× ××××× ×× ×ס×× (2010-2012) 329 ×××× HL ק××ס×ת ×××רת ×× ×¢×××× ×ר×ש×× ×ת שע××¨× ASCT ×ק××ת 16 ××××ר×× ×©× brentuximab vedotin ×××× ×× ×©× 1.8 ×"×\ק"× (165 ×שתתפ××) ×× ×¤×ס×× (164 ×שתתפ××) ××¨× ××ר×× ××× 3 ש×××¢×ת, ××× ×30-45 ×××× ×××ר ××שת××.
×× ×ת×× ××¤× ×××× × ×××¤× (intention to treat) ×ש××× brentuximab ×תר×× ××××ק ×× ×§××ת ×ס××× ××¢×קר×ת, PFS, ××ש×××× ×פ×ס×× (×צ××× PFS: 42.9 [ר××× ×ר-ס×× ×©× 95%: 30.4-42.9] ××¢××ת 24.1 [×××× ×ª×ת××: 11.5, ×××× ×¢××××: ×× × ××ª× ××××××] ×××ש××; ××ס ס×× × [hazard ratio, HR]: 0.57 [0.40-0.81]; p=0.0013). ×ת××¢×ת × brentuximab × ×צ×× ×¢×§××ת ×× ×פ×××× ×תת-×××××ס××ת ××©×ª×ª×¤× ×××קר.
×ת×פע×ת ×××-רצ×××ת ×ש××××ת ×××תר ××§×¨× ×××פ×× brentuximab ××× × ××ר×פת×× ×ª××שת×ת ××קפ×ת (94 ×שתתפ×× [56%] ×ק××צת ×××פ×× ××¢××ת 25 [16%] ×שתתפ×× ×ק××צת ×××ק×רת), ×× ×××ר××¤× ×× (58 [35] ××¢××ת 19 [12%] ×שתתפ××). ש××¢×ר ×ת×××ª× ×עת × ×ת×× ×× ×ª×× ×× ×¢×× ×¢× 17% (28 ×שתתפ××) ×ק××צת ×××פ×× ××¢××ת 16% (25) ×ק××צת ×××ק×רת. ××××©× ×××צ×× × ×ס×× ×× ×××©×¨× ××שר×× ×תר××¤× ×ש×××ש ××××× HL ×ס×××× ××××ר ××××¨× ×× ×תק×××ת ×××ר ASCT. ×ת ×××פ×× ×ש ××ת××× ×××ר ×ת××שש×ת ××שת×ת ת×× ××××¢ ××¤× ×©×ק×× ×עת ק××× × ××16 ××××ר××.
ת×××ת: ×××××××××
×ק×ר: Brentuximab vedotin as consolidation therapy after autologous stem-cell transplantation in patients with Hodgkin's lymphoma at risk of relapse or progression (AETHERA): a randomised, double-blind, placebo-controlled, phase 3 trial Moskowitz, Craig H et al. The Lancet , Volume 385 , Issue 9980 , 1853 â 1862
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)60165-9/fulltext
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