Ch\u00fang t\u00f4i \u0111\u00e3 tham d\u1ef1 h\u1ed9i ngh\u1ecb ESGO \u1edf Copenhagen v\u00e0 xem b\u00e0i thuy\u1ebft tr\u00ecnh v\u1ec1 k\u1ebft qu\u1ea3 nghi\u00ean c\u1ee9u, v\u1ed1n \u0111\u00e3 \u0111\u01b0\u1ee3c FDA ph\u00ea duy\u1ec7t v\u00e0o th\u00e1ng Hai!<\/p>\n
V\u00e0o ng\u00e0y 10 th\u00e1ng 2 n\u0103m 2026,<\/strong> C\u01a1 quan Qu\u1ea3n l\u00fd Th\u1ef1c ph\u1ea9m v\u00e0 D\u01b0\u1ee3c ph\u1ea9m Hoa K\u1ef3 (FDA)<\/strong> \u0111\u00e3 ph\u00ea duy\u1ec7t m\u1ed9t ph\u00e1c \u0111\u1ed3 k\u1ebft h\u1ee3p m\u1edbi g\u1ed3m thu\u1ed1c mi\u1ec5n d\u1ecbch pembrolizumab (Keytruda)<\/strong> v\u00e0 thu\u1ed1c h\u00f3a tr\u1ecb paclitaxel<\/strong> (b\u1ea5t k\u1ec3 c\u00f3 \u0111i\u1ec1u tr\u1ecb \u0111\u1ed3ng th\u1eddi v\u1edbi bevacizumab hay kh\u00f4ng) d\u00e0nh cho b\u1ec7nh nh\u00e2n tr\u01b0\u1edfng th\u00e0nh m\u1eafc ung th\u01b0 bi\u1ec3u m\u00f4 bu\u1ed3ng tr\u1ee9ng, \u1ed1ng d\u1eabn tr\u1ee9ng ho\u1eb7c ung th\u01b0 ph\u00fac m\u1ea1c nguy\u00ean ph\u00e1t kh\u00e1ng platinum<\/strong> , c\u00f3 kh\u1ed1i u d\u01b0\u01a1ng t\u00ednh v\u1edbi PD-L1<\/strong> v\u00e0 \u0111\u00e3 \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb b\u1eb1ng m\u1ed9t ho\u1eb7c hai li\u1ec7u ph\u00e1p to\u00e0n th\u00e2n<\/strong> .<\/p>\n S\u1ef1 ch\u1ea5p thu\u1eadn \u0111\u01b0\u1ee3c c\u1ea5p d\u1ef1a tr\u00ean k\u1ebft qu\u1ea3 cu\u1ed1i c\u00f9ng c\u1ee7a nghi\u00ean c\u1ee9u qu\u1ed1c t\u1ebf giai \u0111o\u1ea1n 3 ENGOT-ov65 \/ KEYNOTE-B96<\/strong> .<\/p>\n Th\u1eed nghi\u1ec7m KEYNOTE-B96 \u0111\u00e3 ch\u1ecdn ng\u1eabu nhi\u00ean 643 b\u1ec7nh nh\u00e2n c\u00f3 kh\u1ed1i u ti\u1ebfn tri\u1ec3n sau khi \u0111i\u1ec1u tr\u1ecb h\u00f3a tr\u1ecb li\u1ec7u d\u1ef1a tr\u00ean platin tr\u01b0\u1edbc \u0111\u00f3. T\u1ea5t c\u1ea3 \u0111\u1ec1u \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb b\u1eb1ng paclitaxel v\u00e0 t\u00f9y ch\u1ecdn bevacizumab; ngo\u00e0i ra, m\u1ed9t n\u1eeda \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb b\u1eb1ng pembrolizumab, n\u1eeda c\u00f2n l\u1ea1i d\u00f9ng gi\u1ea3 d\u01b0\u1ee3c. <\/p>\n Nh\u1eefng ph\u00e1t hi\u1ec7n ch\u00ednh \u1edf b\u1ec7nh nh\u00e2n c\u00f3 kh\u1ed1i u d\u01b0\u01a1ng t\u00ednh v\u1edbi PD-L1<\/strong> :<\/p>\n Th\u1eddi gian s\u1ed1ng kh\u00f4ng ti\u1ebfn tri\u1ec3n b\u1ec7nh (PFS),<\/strong> t\u1ee9c l\u00e0 th\u1eddi gian cho \u0111\u1ebfn khi b\u1ec7nh ti\u1ebfn tri\u1ec3n l\u1ea7n ti\u1ebfp theo, l\u00e0 8,3 th\u00e1ng<\/strong> khi s\u1eed d\u1ee5ng pembrolizumab so v\u1edbi 7,2 th\u00e1ng<\/strong> khi kh\u00f4ng s\u1eed d\u1ee5ng pembrolizumab. \u0110i\u1ec1u n\u00e0y c\u00f3 ngh\u0129a l\u00e0 b\u1ec7nh c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c ki\u1ec3m so\u00e1t trong th\u1eddi gian d\u00e0i h\u01a1n v\u1edbi li\u1ec7u ph\u00e1p k\u1ebft h\u1ee3p. <\/p>\n<\/li>\n Th\u1eddi gian s\u1ed1ng th\u00eam t\u1ed5ng th\u1ec3 (OS)<\/strong> c\u0169ng t\u1ed1t h\u01a1n: trung b\u00ecnh 18,2 th\u00e1ng<\/strong> khi d\u00f9ng pembrolizumab so v\u1edbi 14,0 th\u00e1ng<\/strong> khi kh\u00f4ng d\u00f9ng thu\u1ed1c n\u00e0y, cho th\u1ea5y l\u1ee3i \u00edch s\u1ed1ng th\u00eam \u0111\u00e1ng k\u1ec3.<\/p>\n<\/li>\n<\/ul>\n Nh\u1eefng kh\u00e1c bi\u1ec7t n\u00e0y c\u00f3 \u00fd ngh\u0129a th\u1ed1ng k\u00ea, ngh\u0129a l\u00e0 ch\u00fang kh\u00f4ng th\u1ec3 \u0111\u01b0\u1ee3c quy cho nh\u1eefng bi\u1ebfn \u0111\u1ed9ng ng\u1eabu nhi\u00ean, v\u00e0 cho th\u1ea5y r\u1eb1ng li\u1ec7u ph\u00e1p mi\u1ec5n d\u1ecbch k\u1ebft h\u1ee3p v\u1edbi h\u00f3a tr\u1ecb c\u00f3 th\u1ec3 v\u1eeba l\u00e0m ch\u1eadm ti\u1ebfn tri\u1ec3n b\u1ec7nh v\u1eeba k\u00e9o d\u00e0i tu\u1ed5i th\u1ecd.<\/p>\n S\u1ef1 ch\u1ea5p thu\u1eadn n\u00e0y ch\u1ec9 \u00e1p d\u1ee5ng cho nh\u1eefng b\u1ec7nh nh\u00e2n c\u00f3 kh\u1ed1i u d\u01b0\u01a1ng t\u00ednh v\u1edbi PD-L1<\/strong> , ngh\u0129a l\u00e0 ch\u00fang bi\u1ec3u hi\u1ec7n m\u1ed9t s\u1ed1 d\u1ea5u \u1ea5n mi\u1ec5n d\u1ecbch nh\u1ea5t \u0111\u1ecbnh. V\u00ec m\u1ee5c \u0111\u00edch n\u00e0y, FDA c\u0169ng \u0111\u00e3 c\u00f4ng nh\u1eadn x\u00e9t nghi\u1ec7m PD-L1<\/strong> \u0111i k\u00e8m ( PD-L1 IHC 22C3 pharmDx)<\/em> l\u00e0m c\u01a1 s\u1edf \u0111\u1ec3 l\u1ef1a ch\u1ecdn nh\u1eefng b\u1ec7nh nh\u00e2n c\u00f3 th\u1ec3 h\u01b0\u1edfng l\u1ee3i t\u1eeb li\u1ec7u ph\u00e1p n\u00e0y. <\/p>\n T\u1ea7n su\u1ea5t t\u00e1c d\u1ee5ng ph\u1ee5 khi s\u1eed d\u1ee5ng k\u1ebft h\u1ee3p thu\u1ed1c n\u00e0y t\u01b0\u01a1ng \u0111\u01b0\u01a1ng v\u1edbi kinh nghi\u1ec7m tr\u01b0\u1edbc \u0111\u00e2y khi d\u00f9ng c\u00e1c lo\u1ea1i thu\u1ed1c n\u00e0y v\u00e0 kh\u00f4ng cho th\u1ea5y v\u1ea5n \u0111\u1ec1 an to\u00e0n b\u1ea5t ng\u1edd n\u00e0o. Tuy nhi\u00ean, c\u00e1c ph\u1ea3n \u1ee9ng qua trung gian mi\u1ec5n d\u1ecbch, ph\u1ea3n \u1ee9ng truy\u1ec1n d\u1ecbch v\u00e0 c\u00e1c t\u00e1c d\u1ee5ng ph\u1ee5 \u0111i\u1ec3n h\u00ecnh kh\u00e1c v\u1eabn c\u00f3 th\u1ec3 x\u1ea3y ra, \u0111\u00f3 l\u00e0 l\u00fd do t\u1ea1i sao vi\u1ec7c theo d\u00f5i y t\u1ebf c\u1ea9n th\u1eadn r\u1ea5t quan tr\u1ecdng. <\/p>\n \u2714\ufe0f Ph\u01b0\u01a1ng ph\u00e1p \u0111i\u1ec1u tr\u1ecb m\u1edbi<\/strong> \u2714\ufe0f X\u00e9t nghi\u1ec7m PD-L1 r\u1ea5t quan tr\u1ecdng<\/strong> \u2714\ufe0f Ch\u01b0a \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t t\u1ea1i Ch\u00e2u \u00c2u<\/strong> \u2714\ufe0f M\u1ee9c \u0111\u1ed9 li\u00ean quan \u0111\u1ebfn ch\u0103m s\u00f3c<\/strong>\ud83e\uddea Nghi\u00ean c\u1ee9u \u0111\u00f3 n\u00f3i v\u1ec1 c\u00e1i g\u00ec?<\/strong><\/h3>\n
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\ud83e\uddec X\u00e9t nghi\u1ec7m PD-L1 l\u00e0 \u0111i\u1ec1u ki\u1ec7n ti\u00ean quy\u1ebft<\/strong><\/h3>\n
! An to\u00e0n & T\u00e1c d\u1ee5ng ph\u1ee5<\/strong><\/h3>\n
\n\ud83d\udccd \u0110i\u1ec1u n\u00e0y c\u00f3 \u00fd ngh\u0129a g\u00ec \u0111\u1ed1i v\u1edbi b\u1ec7nh nh\u00e2n \u1edf \u0110\u1ee9c?<\/strong><\/h3>\n
S\u1ef1 ch\u1ea5p thu\u1eadn c\u1ee7a FDA \u0111\u00e1nh d\u1ea5u m\u1ed9t b\u01b0\u1edbc ti\u1ebfn quan tr\u1ecdng: L\u1ea7n \u0111\u1ea7u ti\u00ean, m\u1ed9t li\u1ec7u ph\u00e1p k\u1ebft h\u1ee3p mi\u1ec5n d\u1ecbch \u0111\u00e3 \u0111\u01b0\u1ee3c ch\u00ednh th\u1ee9c ph\u00ea duy\u1ec7t<\/strong> cho b\u1ec7nh ung th\u01b0 bu\u1ed3ng tr\u1ee9ng kh\u00e1ng platinum, d\u01b0\u01a1ng t\u00ednh v\u1edbi PD-L1, v\u00ec c\u00f3 d\u1eef li\u1ec7u v\u1eefng ch\u1eafc v\u1ec1 kh\u1ea3 n\u0103ng k\u00e9o d\u00e0i th\u1eddi gian s\u1ed1ng v\u00e0 ki\u1ec3m so\u00e1t b\u1ec7nh t\u1ed1t h\u01a1n<\/strong> .<\/p>\n
T\u00ecnh tr\u1ea1ng d\u01b0\u01a1ng t\u00ednh v\u1edbi PD-L1<\/strong> l\u00e0 \u0111i\u1ec1u ki\u1ec7n ti\u00ean quy\u1ebft \u0111\u1ec3 s\u1eed d\u1ee5ng thu\u1ed1c n\u00e0y v\u00e0 c\u1ea7n \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh tr\u01b0\u1edbc khi b\u1eaft \u0111\u1ea7u \u0111i\u1ec1u tr\u1ecb, t\u01b0\u01a1ng t\u1ef1 nh\u01b0 c\u00e1c li\u1ec7u ph\u00e1p mi\u1ec5n d\u1ecbch kh\u00e1c.<\/p>\n
T\u1ea1i ch\u00e2u \u00c2u, bao g\u1ed3m c\u1ea3 \u0110\u1ee9c, ph\u01b0\u01a1ng ph\u00e1p \u0111i\u1ec1u tr\u1ecb n\u00e0y v\u1eabn ch\u01b0a \u0111\u01b0\u1ee3c ch\u00ednh th\u1ee9c ph\u00ea duy\u1ec7t,<\/strong> nh\u01b0ng d\u1eef li\u1ec7u \u0111\u00e3 \u0111\u01b0\u1ee3c tr\u00ecnh b\u00e0y v\u00e0 quy tr\u00ecnh ph\u00ea duy\u1ec7t t\u1ea1i EMA \u0111ang \u0111\u01b0\u1ee3c ti\u1ebfn h\u00e0nh. \u0110i\u1ec1u n\u00e0y c\u00f3 ngh\u0129a l\u00e0 b\u1ec7nh nh\u00e2n hi\u1ec7n ch\u01b0a th\u1ec3 \u0111\u01b0\u1ee3c \u00e1p d\u1ee5ng ph\u01b0\u01a1ng ph\u00e1p n\u00e0y m\u1ed9t c\u00e1ch th\u01b0\u1eddng quy, nh\u01b0ng r\u1ea5t c\u00f3 th\u1ec3 n\u00f3 s\u1ebd s\u1edbm \u0111\u01b0\u1ee3c cung c\u1ea5p t\u1ea1i ch\u00e2u \u00c2u trong t\u01b0\u01a1ng lai g\u1ea7n<\/strong> . <\/p>\n
\u0110\u1eb7c bi\u1ec7t \u0111\u1ed1i v\u1edbi nh\u1eefng b\u1ec7nh nh\u00e2n c\u00f3 kh\u1ed1i u kh\u00e1ng platinum v\u00e0 d\u01b0\u01a1ng t\u00ednh v\u1edbi PD-L1, s\u1ef1 k\u1ebft h\u1ee3p n\u00e0y c\u00f3 th\u1ec3 l\u00e0 m\u1ed9t l\u1ef1a ch\u1ecdn \u0111i\u1ec1u tr\u1ecb b\u1ed5 sung quan tr\u1ecdng<\/strong> trong t\u01b0\u01a1ng lai, nh\u1ea5t l\u00e0 khi c\u00e1c li\u1ec7u ph\u00e1p ti\u00eau chu\u1ea9n kh\u00f4ng c\u00f2n hi\u1ec7u qu\u1ea3.<\/p>\n