An amince da TEVIMBRA a Amurka don maganin ciwon daji na ƙashi na farko a cikin esophagus tare da haɗin gwiwa da maganin chemotherapy.

A ranar 4 ga Maris, 2025, BeiGene ta sanar da cewa Hukumar Abinci da Magunguna ta Amurka (FDA) ta amince da TEVIMBRA (tislelizumab-jsgr), tare da maganin chemotherapy mai ɗauke da platinum, don maganin farko ga manya da ke fama da cutar kansar squamous cell carcinoma (ESCC) wadda ciwonta ke bayyana PD-L1 (≥1).

Ƙarin bayanin ya dogara ne akan sakamakon da aka samu daga RATIONALE-306 na BeiGene (NCT03783442), wani bincike na mataki na 3 na duniya wanda aka gudanar bazuwar, wanda aka sarrafa shi ta hanyar placebo, wanda aka makance biyu, don tantance inganci da amincin TEVIMBRA tare da maganin chemotherapy mai ɗauke da platinum a matsayin magani na farko ga manya marasa lafiya (n=649) tare da ESCC mara iya cirewa, wanda aka ci gaba da dawowa a gida ko kuma wanda ya faru a lokacin da aka fara gano shi. Binciken ya cika babban burinsa kuma ya nuna ci gaba mai mahimmanci a kididdiga a cikin rayuwa gabaɗaya (OS) ga manya marasa lafiya da aka yi wa tiyatar TEVIMBRA tare da chemotherapy idan aka kwatanta da placebo tare da chemotherapy. Binciken bincike ya nuna cewa ci gaban da aka samu a cikin mutanen da aka yi niyya don magance (ITT) an danganta shi ne da sakamakon da aka lura a cikin rukunin marasa lafiya da PD-L1 ≥1. Binciken da aka yi kan tsarin aiki na OS a cikin yawan marasa lafiya da aka yi wa magani da PD-L1 (≥1) (n=481) ya nuna matsakaicin tsarin aiki na watanni 16.8 ga marasa lafiya da aka yi wa magani da TEVIMBRA tare da chemotherapy idan aka kwatanta da watanni 9.6 ga marasa lafiya da aka yi wa magani da placebo tare da chemotherapy (HR: 0.66, [95% CI: 0.53, 0.82]), wanda ya haifar da raguwar haɗarin mutuwa da kashi 34%. Waɗannan sakamakon suna wakiltar ci gaba mara misaltuwa a tsarin aiki na OS a cikin marasa lafiya da ke kan gaba a cikin tsarin aiki na ESCC.

Game da TEVIMBRA (tislelizumab-jsgr)®

TEVIMBRA wani nau'in rigakafi ne na musamman wanda aka tsara musamman don hana ƙwayoyin cuta kamuwa da cuta ta hanyar immunoglobulin G4 (IgG4) wanda aka tsara musamman don hana ƙwayoyin cuta mutuwa ta hanyar ƙwayoyin cuta 1 (PD-1) wanda ke da babban ƙarfi da takamaiman alaƙa da PD-1. An tsara shi don rage ɗaurewa ga masu karɓar Fc-gamma (Fcγ) akan macrophages, yana taimaka wa ƙwayoyin garkuwar jiki gano da yaƙi da ƙari.

Game da Ciwon daji na Esophageal Squamous Cell Carcinoma (ESCC)

A duk duniya, ciwon daji na makogwaro shine na shida mafi yawan sanadin mace-mace da suka shafi ciwon daji, kuma ESCC ita ce nau'in histologic da aka fi sani, wanda ya kai kusan kashi 90% na cututtukan daji na makogwaro. An kiyasta cewa sabbin kamuwa da cutar kansar makogwaro 957,000 ne aka yi hasashen a shekarar 2040, karuwar kusan kashi 60% daga shekarar 2020, wanda hakan ke nuna bukatar karin magunguna masu inganci.1 Ciwon daji na makogwaro cuta ce mai saurin kisa, kuma fiye da kashi biyu bisa uku na marasa lafiya suna da cutar da ta ci gaba ko kuma ta ci gaba a lokacin da aka gano cutar, tare da tsammanin cewa za a yi shekaru biyar na rayuwa ƙasa da kashi 6% ga waɗanda ke da cutar da ta yi nisa.

An kuma amince da TEVIMBRA a Amurka a matsayin maganin da ake amfani da shi na lokaci guda don magance manyan marasa lafiya da ke fama da cutar kansar squamous cell da ba a iya cirewa ko kuma ta hanyar metastatic esophageal bayan maganin chemotherapy na tsarin da ba ya haɗa da maganin hana PD-(L)1 da kuma tare da maganin chemotherapy don maganin farko ga manya da ke fama da cutar kansar ciki da ta hanji (G/GEJ).

A halin yanzu, har yanzu akwai gwaje-gwaje da yawa na asibiti na sabbin fasahohin yaƙi da cutar kansa a China waɗanda ke neman marasa lafiya. Tuntuɓi kan sabbin magunguna da fasahohi, zaku iya tuntuɓar Sashen Ƙasa da Ƙasa na Asibitin Oncology na Yankin Kudu na Beijing.

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Nassoshi

1.国家药品监督管理局 (nmpa.gov.cn)

2.百济神州 |癌症没有国界。我们也没有。 (beigene.com)