Hukumar Abinci da Magunguna ta ba da izini pembrolizumab (Keytruda, Merck) a hade tare da chemoradiotherapy (CRT) ga marasa lafiya da FIGO 2014 Stage III-IVA ciwon mahaifa a ranar 12 ga Janairu, 2024.
Wani bincike mai suna KEYNOTE-A18 (NCT04221945) ya duba yadda yake aiki sosai. Ya kasance multicenter, bazuwar, makafi biyu, gwaji mai sarrafa wuribo tare da marasa lafiya na mahaifa 1060 waɗanda ba a taɓa yin tiyata ba, radiation, ko tsarin jiyya. Akwai mutane 596 a cikin gwaji tare da FIGO 2014 Stage III-IVA cuta da kuma 462 mutane tare da FIGO 2014 Stage IB-IIB cuta da ciwon node-positive cuta.
An ba da izini ga mahalarta don karɓar ko dai pembrolizumab 200 mg ko placebo kowane mako 3 don hawan keke na 5 tare da CRT. Kowane mako shida don 15 hawan keke, pembrolizumab 400 MG ko placebo ya zo bayan wannan. Tsarin CRT ya haɗa da cisplatin a kashi na 40 mg / m2 da aka ba ta cikin jini sau ɗaya a mako don hawan hawan 5, tare da yiwuwar ƙarin sake zagayowar 6th, da kuma maganin radiation na waje (EBRT) da kuma farfadowa. An ƙera bazuwar da aka yi la'akari da nau'in da aka yi niyya na maganin radiation na waje (EBRT), matakin ciwon daji, da jimlar adadin da aka yi hasashe.
Alamomin inganci na farko sun haɗa da rayuwa marar ci gaba (PFS) wanda mai binciken ya kimanta bisa ma'auni na RECIST v1.1 ko tabbaci na tarihi, da rayuwa gabaɗaya (OS). Gwajin ya nuna haɓakar ƙididdiga mai mahimmanci a cikin rayuwa marar ci gaba (PFS) a cikin duka ƙungiyar. An gudanar da bincike na ƙungiyar bincike akan marasa lafiya 596 tare da FIGO 2014 Stage III-IVA rashin lafiya. Ƙididdigar haɗarin haɗarin PFS shine 0.59 (95% CI: 0.43, 0.82). A cikin hannun pembrolizumab, 21% na marasa lafiya sun sami wani taron PFS idan aka kwatanta da 31% a cikin hannun placebo. An gudanar da bincike na ƙungiyar bincike akan marasa lafiya 462 tare da FIGO 2014 Stage IB2-IIB cuta. Ƙididdigar PFS HR ita ce 0.91 (95% CI: 0.63, 1.31), yana nuna cewa haɓakar PFS a cikin dukan yawan jama'a an fi gani a cikin marasa lafiya tare da FIGO 2014 Stage III-IVA cuta. Bayanan OS ba su da isasshen haɓaka lokacin da aka gudanar da binciken PFS.
Marasa lafiya da aka bai wa pembrolizumab tare da chemoradiotherapy galibi sun sami sakamako masu illa kamar tashin zuciya, zawo, amai, cututtukan urinary fili, gajiya, hypothyroidism, maƙarƙashiya, asarar ci, riba mai nauyi, ciwon ciki, pyrexia, hyperthyroidism, dysuria, rash, da pelvic. zafi.
Jadawalin adadin da aka ba da shawarar don pembrolizumab shine 200 MG ana gudanar da shi ta cikin jini kowane mako 3 ko 400 MG a cikin jini kowane mako 6, yana ci gaba har zuwa ci gaban cuta, illolin da ba za a iya jurewa ba, ko kuma na tsawon watanni 24. Gudanar da pembrolizumab kafin chemoradiotherapy idan an ba shi a rana guda.
Cancer
Lutetium Lu 177 dotatate an amince da shi ta USFDA don marasa lafiya na yara masu shekaru 12 da haihuwa tare da GEP-NETS
Lutetium Lu 177 dotatate, magani mai ban sha'awa, kwanan nan ya sami izini daga Hukumar Abinci da Magunguna ta Amurka (FDA) ga marasa lafiya na yara, wanda ke nuna gagarumin ci gaba a cikin ilimin cututtukan cututtukan yara. Wannan amincewar tana wakiltar alamar bege ga yara masu fama da ciwace-ciwacen ƙwayoyin cuta na neuroendocrine (NETs), nau'in ciwon daji da ba kasafai ba amma ƙalubale wanda galibi ke tabbatar da juriya ga hanyoyin warkewa na al'ada.
Alysha Mendossa
Bari 11, 2024
