{"id":40651,"date":"2025-07-08T00:02:36","date_gmt":"2025-07-07T17:02:36","guid":{"rendered":"https:\/\/saigonbiz.com.vn\/vi-cau-resin-y-90-sir-spheres-cua-sirtex-medical-duoc-fda-phe-duyet-de-dieu-tri-ung-thu-bieu-mo-te-bao-gan-khong-the-cat-bo\/"},"modified":"2025-07-08T00:02:36","modified_gmt":"2025-07-07T17:02:36","slug":"vi-cau-resin-y-90-sir-spheres-cua-sirtex-medical-duoc-fda-phe-duyet-de-dieu-tri-ung-thu-bieu-mo-te-bao-gan-khong-the-cat-bo","status":"publish","type":"post","link":"https:\/\/saigonbiz.com\/vn\/vi-cau-resin-y-90-sir-spheres-cua-sirtex-medical-duoc-fda-phe-duyet-de-dieu-tri-ung-thu-bieu-mo-te-bao-gan-khong-the-cat-bo\/","title":{"rendered":"Vi c\u1ea7u resin Y-90 SIR-Spheres\u00ae c\u1ee7a Sirtex Medical \u0111\u01b0\u1ee3c FDA ph\u00ea duy\u1ec7t \u0111\u1ec3 \u0111i\u1ec1u tr\u1ecb ung th\u01b0 bi\u1ec3u m\u00f4 t\u1ebf b\u00e0o gan kh\u00f4ng th\u1ec3 c\u1eaft b\u1ecf"},"content":{"rendered":"
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Ch\u1ec9 \u0111\u1ecbnh m\u1edf r\u1ed9ng gi\u00fap<\/i>\u00a0SIR-Spheres<\/i>\u00ae <\/sup><\/i>tr\u1edf th\u00e0nh li\u1ec7u ph\u00e1p n\u00fat m\u1ea1ch x\u1ea1 tr\u1ecb \u0111\u1ea7u ti\u00ean v\u00e0 duy nh\u1ea5t t\u1ea1i Hoa K\u1ef3 \u0111\u01b0\u1ee3c ch\u1ea5p thu\u1eadn \u0111\u1ec3 \u0111i\u1ec1u tr\u1ecb c\u1ea3 ung th\u01b0 bi\u1ec3u m\u00f4 t\u1ebf b\u00e0o gan kh\u00f4ng th\u1ec3 c\u1eaft b\u1ecf v\u00e0 ung th\u01b0 \u0111\u1ea1i tr\u00e0ng di c\u0103n<\/i><\/p>\n

WOBURN, Mass.<\/span>, ng\u00e0y 7 th\u00e1ng 7 n\u0103m 2025<\/span> \/PRNewswire\/ — Sirtex Medical (“Sirtex”)<\/a>, nh\u00e0 s\u1ea3n xu\u1ea5t h\u00e0ng \u0111\u1ea7u trong l\u0129nh v\u1ef1c gi\u1ea3i ph\u00e1p can thi\u1ec7p ung th\u01b0, h\u00f4m nay \u0111\u00e3 th\u00f4ng b\u00e1o r\u1eb1ng C\u1ee5c Qu\u1ea3n l\u00fd Th\u1ef1c ph\u1ea9m v\u00e0 D\u01b0\u1ee3c ph\u1ea9m Hoa K\u1ef3 (FDA) \u0111\u00e3 ph\u00ea duy\u1ec7t vi c\u1ea7u resin Y-90 SIR-Spheres\u00ae<\/sup>\u00a0\u0111\u1ec3 \u0111i\u1ec1u tr\u1ecb ung th\u01b0 bi\u1ec3u m\u00f4 t\u1ebf b\u00e0o gan (HCC) kh\u00f4ng th\u1ec3 c\u1eaft b\u1ecf t\u1ea1i Hoa K\u1ef3. V\u1edbi quy\u1ebft \u0111\u1ecbnh ph\u00ea duy\u1ec7t n\u00e0y, SIR-Spheres\u00ae<\/sup>\u00a0tr\u1edf th\u00e0nh li\u1ec7u ph\u00e1p n\u00fat m\u1ea1ch x\u1ea1 tr\u1ecb duy nh\u1ea5t \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t \u0111\u1ec3 \u0111i\u1ec1u tr\u1ecb c\u1ea3 ung th\u01b0 \u0111\u1ea1i tr\u00e0ng di c\u0103n (mCRC) gan v\u00e0 HCC t\u1ea1i Hoa K\u1ef3.<\/p>\n

Theo Hi\u1ec7p h\u1ed9i Ung B\u01b0\u1edbu Hoa K\u1ef3<\/a>, HCC l\u00e0 d\u1ea1ng ung th\u01b0 gan ph\u1ed5 bi\u1ebfn nh\u1ea5t \u1edf ng\u01b0\u1eddi l\u1edbn t\u1ea1i Hoa K\u1ef3. N\u00fat m\u1ea1ch x\u1ea1 tr\u1ecb \u2013 th\u01b0\u1eddng \u0111\u01b0\u1ee3c g\u1ecdi l\u00e0 li\u1ec7u ph\u00e1p x\u1ea1 tr\u1ecb trong ch\u1ecdn l\u1ecdc (SIRT) \u2013 v\u1edbi SIR-Spheres\u00ae<\/sup>\u00a0s\u1eed d\u1ee5ng ph\u00e9p \u0111o li\u1ec1u l\u01b0\u1ee3ng c\u00e1 nh\u00e2n \u0111\u1ec3 cung c\u1ea5p li\u1ec1u l\u01b0\u1ee3ng b\u1ee9c x\u1ea1 t\u1ed1i \u01b0u tr\u1ef1c ti\u1ebfp \u0111\u1ebfn kh\u1ed1i u \u1edf b\u1ec7nh nh\u00e2n m\u1eafc HCC. Quy\u1ebft \u0111\u1ecbnh ph\u00ea duy\u1ec7t n\u00e0y mang \u0111\u1ebfn cho c\u00e1c b\u00e1c s\u0129 l\u00e2m s\u00e0ng kh\u1ea3 n\u0103ng linh ho\u1ea1t h\u01a1n trong vi\u1ec7c l\u1ef1a ch\u1ecdn li\u1ec7u ph\u00e1p \u0111i\u1ec1u tr\u1ecb gan ph\u00f9 h\u1ee3p v\u1edbi nhu c\u1ea7u v\u00e0 m\u1ee5c ti\u00eau \u0111i\u1ec1u tr\u1ecb c\u1ee5 th\u1ec3 c\u1ee7a t\u1eebng b\u1ec7nh nh\u00e2n.<\/p>\n

Matt Schmidt, T\u1ed5ng Gi\u00e1m \u0111\u1ed1c c\u1ee7a Sirtex cho bi\u1ebft: “Ch\u1ec9 \u0111\u1ecbnh m\u1edf r\u1ed9ng n\u00e0y gi\u00fap SIR-Spheres\u00ae<\/sup>\u00a0tr\u1edf th\u00e0nh ph\u01b0\u01a1ng ph\u00e1p \u0111i\u1ec1u tr\u1ecb Y-90 duy nh\u1ea5t \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t t\u1ea1i Hoa K\u1ef3 cho c\u1ea3 HCC v\u00e0 mCRC. C\u1ed9t m\u1ed1c n\u00e0y cho th\u1ea5y s\u1ef1 t\u1eadn t\u1ee5y kh\u00f4ng ng\u1eebng c\u1ee7a ch\u00fang t\u00f4i trong vi\u1ec7c cung c\u1ea5p c\u00e1c li\u1ec7u ph\u00e1p linh ho\u1ea1t cho t\u1eebng c\u00e1 nh\u00e2n v\u1edbi nhi\u1ec1u l\u1ef1a ch\u1ecdn li\u1ec1u d\u00f9ng h\u00e0ng ng\u00e0y, qua \u0111\u00f3 gi\u00fap c\u00e1c b\u00e1c s\u0129 c\u00f3 th\u1ec3 \u0111i\u1ec1u tr\u1ecb cho b\u1ec7nh nh\u00e2n v\u00e0o th\u1eddi \u0111i\u1ec3m v\u00e0 \u0111\u1ecba \u0111i\u1ec3m ph\u00f9 h\u1ee3p nh\u1ea5t.”<\/p>\n

C\u1ed9t m\u1ed1c ph\u00e1p l\u00fd n\u00e0y \u0111\u01b0\u1ee3c h\u1ed7 tr\u1ee3 b\u1edfi k\u1ebft qu\u1ea3 \u0111\u01b0\u1ee3c \u0111\u00fac k\u1ebft t\u1eeb nghi\u00ean c\u1ee9u DOORwaY90<\/sup>, m\u1ed9t th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng nh\u00e3n m\u1edf, \u0111a trung t\u00e2m, c\u00f3 tri\u1ec3n v\u1ecdng \u0111\u00e1nh gi\u00e1 t\u00ednh an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3 c\u1ee7a SIR-Spheres\u00ae<\/sup>\u00a0trong \u0111i\u1ec1u tr\u1ecb HCC. Nghi\u00ean c\u1ee9u n\u00e0y \u0111\u00e3 tuy\u1ec3n ch\u1ecdn 100 b\u1ec7nh nh\u00e2n t\u1ea1i 18 trung t\u00e2m \u1edf Hoa K\u1ef3, v\u1edbi 65 b\u1ec7nh nh\u00e2n \u0111\u01b0\u1ee3c \u0111\u01b0a v\u00e0o nh\u00f3m \u0111\u00e1nh gi\u00e1 t\u00ednh hi\u1ec7u qu\u1ea3 ch\u00ednh t\u1ea1m th\u1eddi. DOORwaY90<\/sup>\u00a0\u0111\u00e3 \u0111\u00e1p \u1ee9ng c\u00e1c ch\u1ec9 ti\u00eau \u0111\u00e1nh gi\u00e1 \u0111\u1ed3ng ch\u00ednh \u0111\u01b0\u1ee3c ch\u1ec9 \u0111\u1ecbnh tr\u01b0\u1edbc, qua \u0111\u00f3 ch\u1ee9ng minh t\u1ef7 l\u1ec7 \u0111\u00e1p \u1ee9ng t\u1ed5ng th\u1ec3 (ORR) t\u1ed1t nh\u1ea5t l\u00e0 98,5% theo \u0111\u00e1nh gi\u00e1 c\u1ee7a \u0111\u00e1nh gi\u00e1 trung t\u00e2m \u0111\u1ed9c l\u1eadp. T\u1ea5t c\u1ea3 b\u1ec7nh nh\u00e2n c\u00f3 th\u1ec3 \u0111\u00e1nh gi\u00e1 \u0111\u1ec1u cho th\u1ea5y ph\u1ea3n \u1ee9ng, qua \u0111\u00f3 cho th\u1ea5y t\u1ef7 l\u1ec7 ki\u1ec3m so\u00e1t kh\u1ed1i u t\u1ea1i ch\u1ed7 l\u00e0 100%. Ngo\u00e0i ra, th\u1eddi gian \u0111\u00e1p \u1ee9ng trung b\u00ecnh (DoR) \u0111\u1ea1t h\u01a1n 300 ng\u00e0y. Nh\u1eefng k\u1ebft qu\u1ea3 n\u00e0y cho th\u1ea5y r\u00f5 SIR-Spheres\u00ae<\/sup>\u00a0l\u00e0 m\u1ed9t li\u1ec7u ph\u00e1p \u0111i\u1ec1u tr\u1ecb gan c\u00f3 hi\u1ec7u qu\u1ea3 cao v\u1edbi h\u1ed3 s\u01a1 an to\u00e0n thu\u1eadn l\u1ee3i.<\/p>\n

Ti\u1ebfn s\u0129 Armeen Mahvash, B\u00e1c s\u0129 X-quang Can thi\u1ec7p t\u1ea1i Trung t\u00e2m Ung B\u01b0\u1edbu MD Anderson ki\u00eam \u0110\u1ed3ng Nghi\u00ean c\u1ee9u vi\u00ean Ch\u00ednh c\u1ee7a Nghi\u00ean c\u1ee9u DOORwaY90<\/sup>\u00a0cho bi\u1ebft: “Nghi\u00ean c\u1ee9u n\u00e0y gi\u00fap l\u0129nh v\u1ef1c n\u00fat m\u1ea1ch x\u1ea1 tr\u1ecb ph\u00e1t tri\u1ec3n v\u1edbi k\u1ebft qu\u1ea3 li\u1ec1u l\u01b0\u1ee3ng l\u1eb7p l\u1ea1i v\u00e0 h\u1ed3 s\u01a1 an to\u00e0n thuy\u1ebft ph\u1ee5c nh\u1edd k\u1ebft qu\u1ea3 l\u00e2m s\u00e0ng r\u1ea5t t\u00edch c\u1ef1c. \u0110i\u1ec1u n\u00e0y s\u1ebd gi\u00fap c\u00e1c \u0111\u1ed9i ng\u0169 ch\u0103m s\u00f3c \u0111a khoa t\u1ef1 tin h\u01a1n khi \u0111\u1ec1 xu\u1ea5t SIR-Spheres\u00ae<\/sup>\u00a0\u0111\u1ec3 \u0111i\u1ec1u tr\u1ecb HCC.”<\/p>\n

\u0110\u1ec3 bi\u1ebft th\u00eam th\u00f4ng tin v\u00e0 chi ti\u1ebft v\u1ec1 c\u00e1ch s\u1eed d\u1ee5ng SIR-Spheres\u00ae<\/sup>\u00a0trong ho\u1ea1t \u0111\u1ed9ng \u0111i\u1ec1u tr\u1ecb th\u1ef1c t\u1ebf, vui l\u00f2ng li\u00ean h\u1ec7 v\u1edbi Sirtex theo \u0111\u1ecba ch\u1ec9\u00a0info-use@sirtex.com<\/b><\/a>.<\/p>\n

Gi\u1edbi thi\u1ec7u v\u1ec1 SIR-Spheres<\/b>\u00a0\u00ae<\/sup><\/b>\u00a0Vi c\u1ea7u resin Y-90 SIR-Spheres\u00ae<\/sup> \u0111\u01b0\u1ee3c ch\u1ec9 \u0111\u1ecbnh \u0111\u1ec3 ki\u1ec3m so\u00e1t kh\u1ed1i u t\u1ea1i ch\u1ed7 c\u1ee7a ung th\u01b0 bi\u1ec3u m\u00f4 t\u1ebf b\u00e0o gan (HCC) kh\u00f4ng th\u1ec3 c\u1eaft b\u1ecf \u1edf nh\u1eefng b\u1ec7nh nh\u00e2n kh\u00f4ng c\u00f3 x\u00e2m l\u1ea5n m\u1ea1ch m\u00e1u l\u1edbn, x\u01a1 gan Child-Pugh A, ch\u1ee9c n\u0103ng gan \u0111\u01b0\u1ee3c b\u00f9 t\u1ed1t v\u00e0 t\u00ecnh tr\u1ea1ng ho\u1ea1t \u0111\u1ed9ng t\u1ed1t. Lo\u1ea1i vi c\u1ea7u resin n\u00e0y c\u0169ng \u0111\u01b0\u1ee3c ch\u1ec9 \u0111\u1ecbnh \u0111\u1ec3 \u0111i\u1ec1u tr\u1ecb c\u00e1c kh\u1ed1i u gan di c\u0103n kh\u00f4ng th\u1ec3 c\u1eaft b\u1ecf t\u1eeb ung th\u01b0 \u0111\u1ea1i tr\u1ef1c tr\u00e0ng nguy\u00ean ph\u00e1t b\u1eb1ng h\u00f3a tr\u1ecb li\u1ec7u \u0111\u1ed9ng m\u1ea1ch trong gan b\u1ed5 tr\u1ee3 (IHAC) v\u1edbi FUDR (Floxuridine).<\/p>\n

Th\u1eadn tr\u1ecdng: Lu\u1eadt li\u00ean bang (Hoa K\u1ef3) gi\u1edbi h\u1ea1n vi\u1ec7c b\u00e1n thi\u1ebft b\u1ecb n\u00e0y theo y l\u1ec7nh c\u1ee7a b\u00e1c s\u0129. Tham kh\u1ea3o H\u01b0\u1edbng d\u1eabn S\u1eed d\u1ee5ng (<\/b>\u00a0www.sirtex.com\/sir-spheres\/risks_adverse-events<\/b>\u00a0<\/a>) \u0111\u1ec3 bi\u1ebft danh s\u00e1ch \u0111\u1ea7y \u0111\u1ee7 c\u00e1c ch\u1ec9 \u0111\u1ecbnh, ch\u1ed1ng ch\u1ec9 \u0111\u1ecbnh, t\u00e1c d\u1ee5ng ph\u1ee5, c\u1ea3nh b\u00e1o v\u00e0 bi\u1ec7n ph\u00e1p ph\u00f2ng ng\u1eeba.<\/b><\/p>\n

Gi\u1edbi thi\u1ec7u v\u1ec1 Sirtex
<\/b>Sirtex Medical l\u00e0 m\u1ed9t c\u00f4ng ty ch\u0103m s\u00f3c s\u1ee9c kh\u1ecfe to\u00e0n c\u1ea7u t\u1eadp trung v\u00e0o l\u0129nh v\u1ef1c ph\u00e1t tri\u1ec3n c\u00e1c li\u1ec7u ph\u00e1p \u0111i\u1ec1u tr\u1ecb ung th\u01b0 v\u00e0 n\u00fat m\u1ea1ch \u00edt x\u00e2m l\u1ea5n cho gan. V\u1edbi c\u00e1c v\u0103n ph\u00f2ng t\u1ea1i Hoa K\u1ef3, \u00dac, Ch\u00e2u \u00c2u v\u00e0 Ch\u00e2u \u00c1, Sirtex cung c\u1ea5p c\u00e1c gi\u1ea3i ph\u00e1p can thi\u1ec7p ung th\u01b0 v\u00e0 n\u00fat m\u1ea1ch ti\u00ean ti\u1ebfn cho c\u00e1c b\u00e1c s\u0129 v\u00e0 b\u1ec7nh nh\u00e2n tr\u00ean to\u00e0n th\u1ebf gi\u1edbi. S\u1ea3n ph\u1ea9m ch\u1ee7 l\u1ef1c c\u1ee7a c\u00f4ng ty, vi c\u1ea7u resin Y-90 SIR-Spheres\u00ae<\/sup>, hi\u1ec7n l\u00e0 s\u1ea3n ph\u1ea9m duy nh\u1ea5t \u0111\u01b0\u1ee3c FDA ph\u00ea duy\u1ec7t t\u1ea1i Hoa K\u1ef3, \u0111\u01b0\u1ee3c ch\u1ec9 \u0111\u1ecbnh \u0111\u1ec3 \u0111i\u1ec1u tr\u1ecb c\u1ea3 ung th\u01b0 bi\u1ec3u m\u00f4 t\u1ebf b\u00e0o gan (HCC) v\u00e0 ung th\u01b0 \u0111\u1ea1i tr\u00e0ng di c\u0103n (mCRC). \u0110\u1ec3 bi\u1ebft th\u00eam th\u00f4ng tin, h\u00e3y truy c\u1eadp www.sirtex.com<\/a>.<\/p>\n

APM-US-010-06-25<\/p>\n

Logo – https:\/\/mma.prnasia.com\/media2\/926923\/Sirtex_Medical_Logo.jpg?p=medium600<\/a>\u00a0<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

Ch\u1ec9 \u0111\u1ecbnh m\u1edf r\u1ed9ng gi\u00fap\u00a0SIR-Spheres\u00ae tr\u1edf th\u00e0nh li\u1ec7u ph\u00e1p n\u00fat m\u1ea1ch x\u1ea1 tr\u1ecb \u0111\u1ea7u ti\u00ean v\u00e0 duy nh\u1ea5t t\u1ea1i Hoa K\u1ef3 \u0111\u01b0\u1ee3c ch\u1ea5p thu\u1eadn \u0111\u1ec3 \u0111i\u1ec1u tr\u1ecb c\u1ea3 ung th\u01b0 bi\u1ec3u m\u00f4 t\u1ebf b\u00e0o gan kh\u00f4ng th\u1ec3 c\u1eaft b\u1ecf v\u00e0 ung th\u01b0 \u0111\u1ea1i tr\u00e0ng di c\u0103n WOBURN, Mass., ng\u00e0y 7 th\u00e1ng 7 n\u0103m 2025 \/PRNewswire\/ […]\n","protected":false},"author":2604,"featured_media":50415,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"om_disable_all_campaigns":false,"_monsterinsights_skip_tracking":false,"footnotes":""},"categories":[2293],"tags":[],"class_list":["post-40651","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pr-newswire"],"yoast_head":"\nVi c\u1ea7u resin Y-90 SIR-Spheres\u00ae 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