FDA ta amince da Keytruda pembrolizumab a matsayin farkon rigakafin rigakafin cutar kansa don ciwan kansa kai tsaye

Magunguna na Rna

Wannan ita ce amincewar likitancin FDA na 9 da goyan bayan binciken Tsaya Zuwa Cancer.

FDA kwanan nan yarda da immunotherapy miyagun ƙwayoyi pembrolizumab azaman maganin farko-farko ga marasa lafiya da wasu nau'ikan Ciwon daji na mafitsara. Wannan shine amincewar FDA ta 9 da goyan bayan binciken Stand Up To Cancer® (SU2C).

Marasa lafiya da aka kamu da cutar rashin kwanciyar hankali microsatellite mai ci gaba ko metastatic (MSI-H) or rashin daidaituwa na rashin daidaituwa (dMMR) kansar mahaifa a baya za a ba da umarnin pembrolizumab kawai bayan gajiya da daidaitattun jiyya na jiyya.

FDA ta amince da pembrolizumab, wanda kuma aka sani a ƙarƙashin sunan alama keytruda, a matsayin magani na farko don metastatic MSI-H-dMMR kansar colorectal dangane da sakamakon farko daga gwajin asibiti na lokaci na III, wanda tallafin SU2C ya ba da wani ɓangare.

"Lokacin da aka kwatanta da maganin gargajiya, pembrolizumab ya kasance mafi girma tare da raunin sakamako kaɗan ga MSI-H-dMMR marasa daidaito," in ji Luis A. Diaz, MD, Shugaban Sashin Solid Tumor Oncology a Memorial Sloan Kettering Cancer Center kuma shugaban ƙungiyar 2ungiyar Mafarki ta Canwayar Cancer ta SUXNUMXC, wanda ya gudanar da binciken. "Akwai wasu cututtukan cututtukan ƙwayar cuta a cikin manya da yara waɗanda ke da waɗannan lahani na MSI-H-dMMR, don haka bincikenmu na iya samun sakamako ga wasu nau'o'in ciwon daji."

Kusan 4-5% na cututtukan ciwon daji na ƙwayar cuta suna da MSI-H-dMMR masu nazarin halittu, wanda ke haifar da rashin ikon ƙwayoyin halitta don gyara kuskuren da aka yi yayin aikin rarraba salon salula kuma zai iya haifar da ƙarin ci gaban ƙari.

Binciken ya shafi 307 MSI-H-dMMR masu fama da cutar kansa a cikin ƙasashe 23 waɗanda aka kula da su ko dai tare da pembrolizumab ko kuma daidaitaccen ilimin kimiya. Pembrolizumab yayi niyya tare da toshe wani furotin da ake kira PD-1 wanda zai iya hana ƙwayoyin rigakafin da ake kira ƙwayoyin T kawar da ƙwayoyin kansar yadda yakamata.

Dokta Diaz da tawagarsa sun gano cewa marasa lafiya na MSI-H-dMMR wadanda ke fama da cutar sankara tare da pembrolizumab ba su ga cutar kansa ta bazu tsawon watanni 16.5 ba, idan aka kwatanta da marasa lafiyar da aka yi wa magani tare da daidaitaccen maganin cutar sankara wanda suka ga ciwace-ciwacen su sun girma bayan watanni 8.2 na tsakiya. Marasa lafiya masu karɓar magani na yau da kullun sun sami sakamako mai tsanani fiye da marasa lafiya masu karɓar pembrolizumab. Cikakken sakamakon binciken an buga a cikin New England Journal of Medicine a ranar 2 ga Disamba, 2020.

"Standungiyar Mafarki na Tsarin Tsarin Cancer na Cancer ta ba da babbar gudummawa ga ingantaccen zaɓi na magani ga MSI-H-dMMR masu launi," in ji mai ba da lambar yabo ta Nobel Phillip A. Sharp, PhD, shugaban Kwamitin Ba da Shawara kan Kimiyya na Kimiyyar Kimiyya da kuma farfesa a Cibiyar a David H. Koch Institute for Integrative Cancer Research a Massachusetts Institute of Technology. "Wannan babban misali ne game da yadda tsarin hadin gwiwar bincike na hadin gwiwa ke da tasiri kai tsaye kan rayuwar masu cutar kansa."

Cutar sankarau ita ce na biyu mafi yawan sanadin cutar kansa tsakanin maza da mata Amurkawa haɗe da kusan 148,000 Amirkawa za su sami sabon ganewar asali na kansar hanji ko hanji a shekara ta 2020. Yayin da yawan mutuwar sankarau ya ragu sosai saboda ƙaruwar bincike da ci gaba a jiyya, game da 1 cikin 3 manya manya shekaru 50 ko sama da haka kar a ba da shawarar nunawa. Sabbin lokuta na ciwon sankarau sune faruwa a cikin ƙimar girma tsakanin matasa da matasa masu shekaru manya a Amurka, tare da yawan masu cutar kansa a cikin mutanen da ke ƙasa da shekaru 50 ana sa ran kusan ninki biyu by 2030.

Kamar yadda cutar kansa take ci gaba da tasiri ga mutane masu launi
(Baƙar fata suna da mafi girman ƙima na cututtukan fata na kowane jinsi ko kabila a Amurka), haɓaka ci gaba a cikin bincike da sabon salo da kuma maganin da aka sa gaba dole ne ya isa ga duk marasa lafiya. SU2C ta ba da sanarwar shirin Inshorar Lafiya na Lafiya a cikin Janairu 2020. Shirin ya buƙaci duk ƙungiyoyin da ke zuwa nan gaba su nemi Tallafin Cancer don magance ɗaukar ma'aikata da riƙe marasa lafiya daga ƙabilu da ƙabilu daban-daban da kuma al'ummomin da ba su da tsaro don inganta sa hannu iri-iri a cikin gwaji na asibiti. Wannan shirin ya hada da hadin gwiwa tare da kungiyoyin bayar da shawarwari da masana'antu da masu goyon bayan kamfanoni don ciyar da bincike da kokarin wayar da kan jama'a gaba.

SU2C Colorectal Cancer Team ne ke gudanar da kungiyar ta Kimiyyar Kimiyyar Cancer ta kimiyyar, mai Ƙungiyar {asar Amirka don Ciwon Kankara.

Source:

Tsaya Zuwa Ciwon daji

Mirabai Vogt-James
310-739-5576

Labarin jarida:

Tarar, T., et al. (2020) Pembrolizumab a cikin Microsatellite-Rashin kwanciyar hankali – Babban Ciwon Cancer Na Ba Daidai. New England Journal of Medicinedoi.org/10.1056/NEJMoa2017699.

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