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Anasayfa : Endüstriden Haberler : MabThera İle İlgili Son Gelişmeler

MabThera İle İlgili Son Gelişmeler

Amerikan Gıda ve İlaç Dairesi (FDA), Avrupa Komisyonu onayının ardından PRIMA çalışması verilerine dayanarak Rituksimabı (MabThera), folliküler lenfomada birinci basamak idame tedavisinde kullanım için onaylamıştır.
Tüm Hodgkin dışı lenfomaların % 20'sini oluşturan; nüks/remisyonlarla seyreden ve kür şansı olmayan folliküler lenfoma için PRIMA çalışmasına dayanılarak, Rituksimab + kemoterapi ile başlangıç tedavisine yanıt veren ileri evre hastalarda, iki yıl boyunca iki ayda bir Rituksimab uygulamasının, bu hastaların hastalıkları kötüleşmeden yaşama olasılığını (progresyonsuz sağkalım), tedavilerine son veren hastalara kıyasla yaklaşık iki katına çıkardığı gösterilmiştir.


“İzle ve Bekle” çalışmasında, asemptomatik folliküler lenfoma hastalarında indüksiyon ve idame tedavisinde Rituksimab (MabThera) kullanımının ek tedavi gereksinmesini %80 azalttığı gösterildi.
İngiltere University College London Hastaneleri tarafından yürütülen faz III çalışma olan 'İzle ve Bekle' çalışmasında, önceden tedavi edilmemiş asemptomatik evre II-IV folliküler lenfomalı hastalar, Rituksimab’ın birinci basamak indüksiyonu ve ardından idame olarak kullanımı (4 kez haftalık dozun ardından 2 yıl boyunca 2 ayda bir idame dozları) güvenlilik ve etkililik profili açısından yakın izlem ile karşılaştırılmıştır. 'İzle ve Bekle' çalışma verileri, Rituksimab’ın ilk basamakta tek başına kullanımını izleyen idame kullanımının, asemptomatik folliküler lenfoma hastalarında yakın izleme kıyasla kemoterapi ya da radyoterapi ihtiyacını geciktirdiğini ve hastalığın kötüleşme riskini azalttığını (progresyonsuz sağkalım) göstermiştir.
Açıklanan veriler; klasik olarak bilinen asemptomatik hastaların tedavisi “yakın izlem” yaklaşımıyla yönetilir ve bu hastaların tedavisi belirli semptomlar görülene ya da hastalıkları kötüleşene kadar başlatılmaz” kanısının aksine, ilgili hasta grubunda erken uygulanacak tedavinin önemini vurgulamaktadır.

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