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Ciwon nono na Farko: Ta yaya Verzenio zai iya taimakawa?

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Hukumar Abinci da Magunguna ta Amurka (FDA) ta amince da Eli Lilly da Kamfanin (NYSE: LLY) Verzenio® (abemaciclib), a haɗe tare da maganin endocrine (tamoxifen ko mai hana aromatase), don adjuvant jiyya na manya marasa lafiya tare da mai karɓar hormone- tabbatacce (HR+), mai karɓar raunin epidermal girma mai karɓar 2-korau (HER2-), node-tabbatacce, farkon cutar sankarar nono (EBC) a babban haɗarin sake dawowa da ƙimar Ki-67 na ≥20% kamar yadda FDA ta amince gwaji. Ki-67 alama ce ta yaduwar salula. Verzenio shine farkon kuma kawai mai hana CDK4/6 wanda aka yarda dashi ga wannan yawan masu haƙuri.

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"Bayan lokaci, sakamakon haɗin gwiwa na shirin ci gaban asibiti na Verzenio ya nuna bambancin bayanin mai hana CDK4/6, da mahimman bayanai daga gwajin monarchE wanda ya goyi bayan wannan sabon nuni a cikin HR+ HER2- farkon cutar sankarar nono tana wakiltar wani muhimmin mataki na gaba ga mutane. waɗanda ke buƙatar sabbin zaɓuɓɓukan magani, ”in ji Jacob Van Naarden, babban mataimakin shugaban ƙasa, Shugaba na Loxo Oncology a Lilly kuma shugaban, Lilly Oncology. "Mun yi farin ciki da wannan yarda ta farko a cikin adjuvant kuma yayin da waɗannan bayanan ke ci gaba da girma, muna ɗokin samun ƙarin damar yin aiki tare da hukumomin kiwon lafiya don faɗaɗa amfani da Verzenio a wannan yanayin."

shi Verzenio Phase 3 monarchE test is a randomized (1: 1), open-label, cohort two, multicenter study in adult women and men with HR+ HER2-, node-positive, resected EBC with clinical and pathological features matching with a high risk na sake kamuwa da cuta. A cikin gwajin, marasa lafiya sun kasance bazuwar don karɓar shekaru biyu na Verzenio 150 MG sau biyu a rana tare da zaɓin likita na daidaitaccen maganin endocrine, ko daidaitaccen tsarin endocrine kawai. An umurci marasa lafiya a cikin hannayen magunguna biyun da su ci gaba da karɓar maganin endocrine na adjuvant har zuwa shekaru 5-10 kamar yadda likitan su ya ba da shawara. Ƙarshen ƙarshen binciken shine rayuwa mai cutarwa (IDFS) kuma an sadu da shi a cikin takamaiman bincike na ɗan lokaci a cikin niyyar-don-bi (ITT), tare da ingantaccen ci gaba a cikin IDFS ga marasa lafiya da aka bi da Verzenio da. ET idan aka kwatanta da waɗanda aka bi da ET kadai. Daidai da jagororin ƙwararru, an ayyana IDFS azaman tsawon lokaci kafin cutar sankarar mama ta dawo, kowane sabon ciwon kansa ke tasowa, ko mutuwa. 

Bayan samun nasarar ƙarshen binciken a cikin yawan mutanen da aka yi rajista, an kuma gudanar da bincike na musamman na IDFS a cikin marasa lafiya waɗanda ke da haɗarin asibiti mai haɗari da abubuwan cututtukan cuta da ƙimar Ki-67 ≥20%. Wannan bincike na ƙungiya (N = 2,003) ya haɗa da marasa lafiya tare da ≥4 tabbatattun ƙwayoyin lymph axillary (ALN), ko 1-3 tabbatacce ALN tare da ko dai cutar Grade 3 da/ko girman girman ≥5 cm, kuma wanda ciwan kansa ke da maki Ki-67. da ≥20%. Har ila yau, akwai ingantaccen ci gaba na ƙididdiga a cikin IDFS don wannan rukunin ƙungiyar da aka riga aka ƙayyade na marasa lafiya da ke karɓar Verzenio da ET idan aka kwatanta da waɗanda suka karɓi ET kadai (HR = 0.643, 95% CI: 0.475, 0.872, p = 0.0042).1,3

Wannan yardar ta dogara ne akan sakamakon inganci daga nazarin wannan rukunin rukunin tare da ƙarin bin diddigin, wanda aka gudanar bayan-hoc. A cikin wannan binciken, Verzenio da aka bayar a hade tare da ET ya ci gaba da nuna fa'ida mai ma'ana ta asibiti, tare da raguwar kashi 37 cikin ɗari na haɗarin sake kamuwa da cutar sankarar nono ko mutuwa idan aka kwatanta da daidaitaccen adjuvant ET kawai ga marasa lafiya da ke da haɗarin asibiti da fasali na zahiri da Ki. -67 ci ≥20% (HR: 0.626 [95% CI: 0.49-0.80]), da cikakkiyar fa'ida a cikin adadin taron IDFS na kashi 7.1 cikin ɗari uku. Adadin abubuwan da suka faru na IDFS a lokacin wannan bincike shine 104 tare da Verzenio da ET idan aka kwatanta da 158 tare da ET kadai. Bayanai cikakkun bayanai ba su balaga ba kuma ana ci gaba da bin diddigin.

Munanan halayen daga masarautarE sun yi daidai da sanannen bayanin martaba na Verzenio.2 An kimanta aminci da haƙuri a cikin marasa lafiya 5,591. Mafi yawan halayen halayen da aka ruwaito (> 10%) a cikin Verzenio plus ET (tamoxifen ko mai hana aromatase), da> 2% sama da hannun ET kadai, sune gudawa, cututtuka, gajiya, tashin zuciya, ciwon kai, amai, stomatitis , rage cin abinci, dizziness, rash, da alopecia.3 Abubuwan da aka saba amfani da su na dakin gwaje -gwaje (duk maki ≥10%) sun haɓaka creatinine, ƙimar sel fararen jini ya ragu, ƙimar neutrophil ta ragu, anemia, ƙimar lymphocyte ta ragu, ƙididdigar platelet ta ragu, ALT ya ƙaru, AST ya ƙaru, da hypokalemia.

Wannan amincewar ta FDA ta ginu ne akan kafaffiyar shaidar Verzenio, wacce aka riga aka amince da ita don maganin wasu nau'ikan HR+ HER2- ci gaba ko ciwon sankarar nono. Tare da wannan yarda, FDA ta faɗaɗa amfani da Verzenio a cikin dukkan alamomi, lokacin da aka ba shi a haɗe tare da maganin endocrine, don haɗa maza. Ana samun Verzenio a cikin ƙarfin kwamfutar hannu na 200 MG, 150 MG, 100 MG, da 50 MG.

Sara M. Tolaney, MD, MPH, Makarantar Kiwon Lafiya ta Harvard, Dana Farber Cancer Institute, kuma mai bincike kan binciken masarautar. "Wannan amincewar FDA don Verzenio a haɗe tare da maganin endocrine a farkon sa ciwon nono yana da yuwuwar zama sabon ma'aunin kulawa ga wannan yawan. An ƙarfafa mu ta hanyar raguwar haɗarin haɗarin sake dawowa ko da bayan lokacin jiyya na shekaru biyu a cikin waɗannan marasa lafiya, kuma ina godiya don samun damar ba da wannan azaman zaɓi na jiyya ga marasa lafiya na. ”  

“Mata da maza da ke da haɗari mai haɗari HR+ HER2- farkon cutar sankarar nono suna son yin duk abin da za su iya don rage haɗarin cutar ta dawo, tare da fatan rayuwa ba tare da cutar kansa ba. Amincewar Verzenio yana ba da sabon zaɓin magani don taimaka musu yin hakan, ”in ji Jean Sachs, babban jami'in zartarwa, Rayuwa Bayan Ciwon Nono. "Wannan yardar ta kawo sabon fata ga al'ummar kansar nono."

Bayanai da ke tallafawa wannan yarda za a gabatar da su a 14 ga watan Oktoba Ƙungiyar Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararru (ESMO).

Alamar Verzenio ta ƙunshi gargaɗi da taka tsantsan don gudawa, neutropenia, cutar huhu ta tsakiya (ILD/pneumonitis), hepatotoxicity, venous thromboembolism, da guba na tayi. Koyar da marasa lafiya a farkon alamar saɓo mai ɗorawa don fara aikin maganin zazzabin cizon sauro, ƙara yawan ruwa, da sanar da mai ba da lafiyarsu. Yi cikakken ƙididdigar jini da gwajin aikin hanta kafin fara aikin Verzenio, kowane mako biyu na watanni biyu na farko, kowane wata don watanni biyu masu zuwa kuma kamar yadda aka nuna a asibiti. Dangane da sakamako, Verzenio na iya buƙatar canjin kashi. Kula da marasa lafiya don alamomi da alamun thrombosis da embolism na huhu da bi da lafiya daidai. Ba da shawara ga majiyyacin haɗarin haɗari ga tayin da yin amfani da ingantaccen maganin hana haihuwa.

Dubi Muhimman Bayanan Tsaro a ƙasa kuma cikakke Adana Bayani don ƙarin bayani.

Click nan don duba bayanan kansar nono na farko.

Click nan don duba bayanan bayanan gwaji na monarchE.

Danna don duba hotunan samfurin Verzenio: 50 MG100 MG150 MG200 MG.

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Juergen T Steinmetz

Juergen Thomas Steinmetz ya ci gaba da aiki a masana'antar tafiye-tafiye da yawon buɗe ido tun yana saurayi a Jamus (1977).
Ya kafa eTurboNews a cikin 1999 azaman wasiƙar farko ta yanar gizo don masana'antar yawon shakatawa ta duniya.

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