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[title] => FDA odobrila prvu imunoterapija za rak dojke; Stručnjaci pojasnili što bi takva terapija značila za oboljele od opake bolesti
[alias] => fda-odobrila-prvu-imunoterapija-za-rak-dojke-strucnjaci-pojasnili-sto-bi-takva-terapija-znacila-za-oboljele-od-opake-bolesti
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Američka agencija za hranu i lijekove (FDA) izdala je odobrenje za prvu imunoterapiju za rak dojke – objavio je CNN.
Terapija je dobila ubrzano odobrenje za trostruko negativan rak dojke koji je ili lokalno uznapredovao ili metastazirao, a koji ne može biti kirurški odstranjen i čije stanice sadrže protein PD-L1. Terapija je kombinacija imunoterapije i kemoterapije (Tecentriq i Abraxane).
Odobrenje je stiglo nakon što je listopadska studija, objavljena u New England Journal of Medicine, pokazala da terapija produžuje vrijeme za koje se pacijenticama stanje ne pogoršava.
U podgrupi PD-L1 je 7,4 mjeseca prosječno vrijeme bez progresije bolesti kod onih koji su dobili kombinirani tretman, u odnosu na 4,8 mjeseca za pacijentice koji su kemoterapiju primile s placebom.
- To je prvi put da je imunoterapija djelovala na rak kojeg je teško liječiti, i to je veliki korak naprijed za takve pacijentice – rekao je glavni autor studije dr. Peter Schmid, s londonskog Sveučilišta Queen Mary kada studija bila objavljena u medicinskom časopisu.
- Odobrenje agencije se temeljni na produženom vremenu bez napredovanja, s nadom da će podaci u budućnosti pokazati da tretman zapravo čini da žene žive duže – rekao je dr. Otis Brawley, prof. onkologije i epidemologije sa Sveučilišta Johns Hopkins.
Radi se o ubrzanom odobrenju za lijekove koji tretiraju ozbiljna stanja, koje je izdano temeljem podataka koji sugeriraju da postoji klinička korist, ali je ne pokazuju direktno.
Proizvođač još mora potvrditi njegovu blagotvornost. Ako se to dogodi, lijek će dobiti pravo odobrenje. U suprotnom, agencija može povući lijek, što se već događalo.
Stručnjaci poručuju da je to tek početak korištenja imunoterapije u liječenju raka dojke.
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[cleanTitle] => FDA odobrila prvu imunoterapija za rak dojke; Stručnjaci pojasnili što bi takva terapija značila za oboljele od opake bolesti
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Američka agencija za hranu i lijekove (FDA) izdala je odobrenje za prvu imunoterapiju za rak dojke – objavio je CNN.
Terapija je dobila ubrzano odobrenje za trostruko negativan rak dojke koji je ili lokalno uznapredovao ili metastazirao, a koji ne može biti kirurški odstranjen i čije stanice sadrže protein PD-L1. Terapija je kombinacija imunoterapije i kemoterapije (Tecentriq i Abraxane).
Odobrenje je stiglo nakon što je listopadska studija, objavljena u New England Journal of Medicine, pokazala da terapija produžuje vrijeme za koje se pacijenticama stanje ne pogoršava.
U podgrupi PD-L1 je 7,4 mjeseca prosječno vrijeme bez progresije bolesti kod onih koji su dobili kombinirani tretman, u odnosu na 4,8 mjeseca za pacijentice koji su kemoterapiju primile s placebom.
- To je prvi put da je imunoterapija djelovala na rak kojeg je teško liječiti, i to je veliki korak naprijed za takve pacijentice – rekao je glavni autor studije dr. Peter Schmid, s londonskog Sveučilišta Queen Mary kada studija bila objavljena u medicinskom časopisu.
- Odobrenje agencije se temeljni na produženom vremenu bez napredovanja, s nadom da će podaci u budućnosti pokazati da tretman zapravo čini da žene žive duže – rekao je dr. Otis Brawley, prof. onkologije i epidemologije sa Sveučilišta Johns Hopkins.
Radi se o ubrzanom odobrenju za lijekove koji tretiraju ozbiljna stanja, koje je izdano temeljem podataka koji sugeriraju da postoji klinička korist, ali je ne pokazuju direktno.
Proizvođač još mora potvrditi njegovu blagotvornost. Ako se to dogodi, lijek će dobiti pravo odobrenje. U suprotnom, agencija može povući lijek, što se već događalo.
Stručnjaci poručuju da je to tek početak korištenja imunoterapije u liječenju raka dojke.
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14. svibanj 2024 18:48
