Nyamavhuvhu 20, 2021: Munguva pfupi yapfuura muna Chivabvu, 2021 Lumakras (sotorasib) yakagamuchirwa ne US Chikafu uye Dzvinyu Dhiza sekutanga kurapwa kwevarwere vakuru vane isiri-diki cell cancer yemapapu avo vakamboitwa kamwechete kekutanga systemic therapy uye vane mapundu ane chaiyo mhando yemajini mutation inonzi KRAS G12C. Iyi ndiyo yekutanga kurapa yakanangwa yakatenderwa hutsinye nechero KRAS mutation, iyo inoverengera inosvika makumi maviri neshanu muzana ekuchinja mune asiri madiki cell cancer cancer. Mune asiri madiki maseru emapapu mamota, KRAS G25C shanduko inotora inosvika 12% yekuchinja kwese.
"KRAS shanduko yakagara ichionekwa seisingagone kurapwa nemushonga, zvichimiririra chishuwo chechokwadi chevarwere vane mamwe marudzi ekenza," akadaro Richard Pazdur, MD, director weFDA's Oncology Center of Excellence uye director director weHofisi yeOncologic Zvirwere mu iyo FDA's Center yeKuongorora Zvinodhaka uye Tsvagiridzo. "Kubvumidzwa kwanhasi kunomiririra danho rinokosha rakanangana neramangwana apo varwere vazhinji vachange vaine marapirwo akaitwa munhu zvichienderana."
The genetic abnormalities that cause kenza yemapapu, the most prevalent cancer type with the greatest fatality rate, can be roughly classified. KRAS is a mutation that affects a collection of genes involved in cell development and division.
In a study of 124 patients with KRAS G12C-mutated isina-diki kenza yemapapu kenza who had progressed after receiving an immune checkpoint inhibitor and/or platinum-based chemotherapy, researchers looked at the efficacy of Lumakras. The objective response rate (the percentage of patients whose tumours are eradicated or decreased) and the duration of response were the two main outcomes assessed. The objective response rate was 36%, with 58 percent of patients reporting a six-month or longer duration of response.
Iyo 960 mg dose yakabvumidzwa zvichibva pahuchapupu huripo hwekiriniki pamwe ne pharmacokinetic uye pharmacodynamic modhi yaitsigira iyo dosi. Hurumende iri kuda kuyedza postmarketing sechikamu chekuwongorora kweiyi mvumo inokosheswa kuona kana muyero wakaderera uchave nemhedzisiro yekurapa.
Dhairrhea, kurwadziwa musculoskeletal, kuda kurutsa, kupera simba, kukuvara kwechiropa, uye kukosora ndiyo mhedzisiro yakaipisisa yeLumakras. Lumakras inofanirwa kudzivirirwa kana varwere vachiratidza zviratidzo zvepakati pemapapu chirwere, uye vanofanirwa kumiswa zvachose kana chirwere chikaonekwa. Usati watanga uye uchinge uchishandisa Lumakras, vashandi vezvehutano vanofanirwa kuongorora murwere chiropa chekuita basa bvunzo. Lumakras inofanira kuchengetwa, kuderedzwa, kana kugumiswa zvizere kana murwere akatanga kukuvara kwechiropa. Paunenge uchitora Lumakras, varwere vanofanirwa kudzivirira kunwa acid-inoderedza mishonga, zvinodhaka zvinomutsa kana substrates kune mamwe enzyme echiropa, uye zvinodhaka zviri P-glycoprotein substrates.
Lumakras yakagamuchirwa kuburikidza neiyo FDA's Accelerated Approval nzira, iyo inobvumidza iyo agency kubvumidza mishonga yezvirwere zvakakomba uko kune chisingaenzanisike zvekurapa uye kurapwa kwakaratidzwa kuve nemimwe mhedzisiro mhedzisiro iyo ingangoita kufanotaura nezvekiriniki kubatsira varwere. Kumwe kutsvagurudza kunodiwa kusimbisa uye kutsanangura Lumakras 'zvingangoita zvemakiriniki zvakanakira.
Ichi chishandiso chakagashira Fast Track, Yekutanga Kudzokorora, uye Breakthrough Therapy kudomwa kubva kuDFA.
Lumakras yakasarudzwawo seNherera Zvinodhaka, iyo inopa zvinokurudzira zvemari kubatsira uye kukurudzira kuvandudzwa kwemishonga yezvirwere zvisingawanzoitika.
Purojekiti Orbis, iyo FDA Oncology Center yeYakanakisa kuedza, yakashandiswa kuita ongororo iyi. Project Orbis inogadzira mashandiro evamwe vanobatana pasirese kuendesa uye kuongorora mishonga yeoncology panguva imwe chete. FDA yakashanda pamwe neTherapeutic Goods Administration (TGA) yeAustralia, yeBrazil Health Regulatory Agency (ANVISA), Health Canada, uye neMedicine uye Healthcare Zvigadzirwa Regulatory Agency pane ino ongororo (MHRA; United Kingdom). Mimwe miviri yekutonga ichiri kuongorora mashandisiro acho.
Amgen Inc. yakagamuchira FDA tendero yeLumakras.
Pamwe naLumakras, iyo FDA yakabvumidza iyo QIAGEN therascreen KRAS RGQ PCR kit (yakatenderwa neQIAGEN GmbH) uye Guardant360 CDx (yakasimbiswa naGuantant Health, Inc.) seLumakras shamwari yekuongorora. Kuongorora kana Lumakras iri kurapwa kwakakodzera kwevarwere, iyo QIAGEN GmbH bvunzo inoongorora tumarara turu uye iyo Guardant Health, Inc. bvunzo inoongorora plasma specimens. Kana pasina shanduko inowanikwa mune yeplasma sampuro, bundu remurwere rinofanirwa kuongororwa.
Kunobva: https://www.fda.gov/
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