Agusta 20, 2021: Kwanan nan a cikin Mayu, 2021 Lumakras (sotorasib) ya amince da shi Hukumar Abinci da Magunguna ta Amurka a matsayin magani na farko ga manya masu fama da ciwon huhu marasa ƙananan ƙwayoyin cuta waɗanda aka yi aƙalla maganin tsarin tsarin da suka gabata kuma wanda ciwace-ciwacen su ke da takamaiman nau'in maye gurbi mai suna KRAS G12C. Wannan shine farkon maganin da aka yi niyya da aka amince da shi don rashin lafiya tare da kowane maye gurbi na KRAS, wanda ke da kusan kashi 25% na maye gurbi a cikin cututtukan da ba ƙananan ƙwayoyin cuta ba. A cikin ciwace-ciwacen huhu mara ƙanƙanta, maye gurbin KRAS G12C ya kai kusan kashi 13% na duk maye gurbi.
Richard Pazdur, MD, darektan Cibiyar Kwarewa ta Oncology ta FDA kuma darektan riko na Ofishin Cututtukan Oncologic a cikin ya ce "An dade ana daukar maye gurbin KRAS mai jure wa maganin miyagun ƙwayoyi, yana wakiltar buƙatu na gaske ga marasa lafiya da wasu nau'ikan ciwon daji." Cibiyar Nazarin Magunguna da FDA ta FDA. "Yin amincewar yau yana wakiltar wani muhimmin mataki zuwa gaba inda ƙarin marasa lafiya za su sami tsarin kulawa na musamman."
The genetic abnormalities that cause kwayar cutar huhu, 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 cututtukan daji na kansa marasa kansar 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.
An yarda da kashi na 960 MG bisa la'akari da samuwan shaidar asibiti da kuma samfurin pharmacokinetic da pharmacodynamic waɗanda ke goyan bayan kashi. Gwamnati na buƙatar gwajin tallace-tallace a matsayin wani ɓangare na kimantawa don wannan haɓakar amincewa don ganin ko ƙaramin kashi zai sami irin wannan tasirin warkewa.
Zawo, ciwon musculoskeletal, tashin zuciya, gajiya, lalacewar hanta, da tari sune mafi yawan illolin Lumakras. Ya kamata a guji Lumakras idan majiyyata sun nuna alamun cututtukan huhu na tsaka-tsaki, kuma ya kamata a dakatar da su gaba daya idan an gano cutar. Kafin farawa da lokacin amfani da Lumakras, masu aikin kiwon lafiya yakamata su kimanta gwajin aikin hanta na majiyyaci. Lumakras ya kamata a riƙe, saukar da kashi, ko ƙare gabaɗaya idan majiyyaci ya sami lalacewar hanta. Yayin shan Lumakras, marasa lafiya ya kamata su guje wa shan magunguna masu rage acid, magungunan da ke haifar da ko kuma masu maye gurbin wasu enzymes na hanta, da magungunan da ke cikin P-glycoprotein substrates.
An amince da Lumakras ta hanyar FDA's Accelerated Approval pathway, wanda ke ba hukumar damar amincewa da magunguna don cututtuka masu tsanani inda akwai buƙatar likita da ba a biya ba kuma an nuna cewa maganin yana da tasiri na musamman wanda zai iya yin hasashen fa'idar asibiti ga marasa lafiya. Ana buƙatar ƙarin bincike don tabbatarwa da ayyana yuwuwar fa'idodin asibiti na Lumakras.
Wannan aikace-aikacen ya karɓi Fast Track, Bita na Farko, da Nasihun Farfaɗo na Farko daga FDA.
An kuma sanya Lumakras a matsayin Magungunan Marayu, wanda ke ba da ƙwarin gwiwar kuɗi don taimakawa da haɓaka haɓakar jiyya don rashin lafiya.
Anyi amfani da Orbis Project, Cibiyar Koyon Ciwon Kanjamau ta FDA na Kwarewa, don yin wannan bita. Project Orbis yana ƙirƙira wata hanya don abokan haɗin gwiwa na duniya don ƙaddamarwa da sake nazarin magungunan oncology a lokaci guda. FDA ta yi aiki tare da Therapeutic Product Administration (TGA) na Ostiraliya, Hukumar Kula da Lafiya ta Brazil (ANVISA), Health Canada, da Hukumar Kula da Magunguna da Kayayyakin Kiwon Lafiya akan wannan bita (MHRA; United Kingdom). Sauran hukumomin da ke kula da ayyukan har yanzu suna bitar aikace -aikacen.
Amgen Inc. ya karɓi amincewar FDA don Lumakras.
Tare da Lumakras, FDA ta amince da kayan aikin QIAGEN therascreen KRAS RGQ PCR (wanda QIAGEN GmbH ya yarda da shi) da Guardant360 CDx (wanda Guardant Health, Inc. ya tabbatar) azaman binciken abokin Lumakras. Don tantance idan Lumakras magani ne mai dacewa ga marasa lafiya, gwajin QIAGEN GmbH yayi nazarin ƙwayar ƙwayar cuta da kuma Guardant Health, Inc. gwajin yana nazarin samfuran plasma. Idan ba a sami maye gurbi a cikin samfurin plasma ba, yakamata a tantance ƙwayar majiyyaci.
source: https://www.fda.gov/
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