Maganin ciwon daji na pancreatic, ciwon daji na pancreatic maye gurbin BRCA da aka yi niyya olaparib (Olaparib, Liprot Lynparza) ya sami tallafin ƙwararrun FDA
Saboda ƙaƙƙarfan ɓarna da ƙayyadaddun magani na ciwon daji na pancreatic, ba a ƙaddamar da wani maganin ci gaba ba a cikin ƴan shekarun da suka gabata, kuma marasa lafiya da ke fama da ciwon daji na pancreatic suna buƙatar sabbin magunguna da magunguna masu inganci cikin gaggawa. A duk duniya, abin da ke faruwa na maye gurbi na ƙwayoyin cuta na BRCA a cikin ciwon daji na ciki shine 5-7%.
The targeted drug olapaly, which specifically targets BRCA mutations, has achieved excellent clinical data in the maintenance treatment of ciwon cizon sauro, which is enough to improve the current clinical treatment and help patients with advanced pancreatic cancer prolong their survival. A watan Oktoban 2018, Hukumar Abinci da Magunguna ta Amurka (FDA) ta ba da olapaly maganin magungunan maraya don cutar kansa.
Olaparib yana da goyan bayan kwamitin masana na FDA don maganin gBRCAm ciwon sankara
A ranar 17 ga Disamba, Hukumar Kula da Abinci da Magunguna ta Amurka (FDA) Kwamitin Ba da Shawarwari kan Magunguna na Oncology (ODAC) ta zaɓi 7 zuwa 5 don ba da shawarar amincewa da maganin cutar kansa da aka yi niyya Lynparza (sunan China: Liprot, sunan gama gari): Olaparib, olaparib), a matsayin tsarin kulawa na farko na monotherapy, jiyya ga marasa lafiya da ciwon daji na pancreatic metastatic waɗanda ba su da ci gaba bayan sun karɓi maganin chemotherapy na platinum na farko na akalla makonni 16 kuma suna ɗaukar maye gurbin BRCA (gBRCAm).
ƙaddamarwar sNDA ta dogara ne akan kyakkyawan sakamako na gwaji na POLO 3 da aka buga a cikin New England Journal of Medicine kuma aka buga a 2019 American Society of Clinical Oncology (ASCO) taron shekara-shekara. Sakamakon ya nuna cewa ƙididdiga da mahimmancin asibiti na rayuwa ba tare da ci gaba ba (PFS) ya inganta sosai, yana rage haɗarin ci gaba da cututtuka ko mutuwa da 47%.
Olaparib kusan ninki biyu ne na lokacin rayuwa na marasa lafiyar da ke fama da cutar sankara mai saurin yaduwa tare da maye gurbin BRCA (watanni 3.8 da 7.4).
Olapali has been approved by the US FDA for the treatment of ovarian and ciwon nono. Olaparib was approved by the US FDA in December 2014 to become the first PARP inhibitor approved globally, and has been approved in 65 countries around the world.
The good news is that Olapali has been approved for listing in China for the treatment of ciwon daji na ovarian, and was included in the medical insurance catalog at the end of November this year. The price of drugs has dropped by about 60%. After the price reduction, it should be less than 10,000 yuan per box. According to 70% of medical insurance reimbursement, the price of each box of olapaly is almost 3,000 yuan, and the monthly cost of medication is 6,000 yuan.
Alamu biyu na Olapali
A watan Agusta 2018, an yarda da Olapali don yin rajista a China, ya zama magani na farko da kasar Sin ta kera don cutar sankarar jakar kwai, wanda aka yi amfani da shi wajen kula da cutar sankarar mahaifa mai yaduwar sinadarin platinum (yanayin kwanciyar hankali bayan maganin platinum, Ola Pali na iya jinkirta lokacin da zai koma).
A ranar 5 ga Disamba, 2019, China’s State Drug Administration has officially approved the use of olapa for first-line maintenance treatment of patients with BRCA-mutated advanced ovarian cancer. Benefiting from China’s vigorous support for pharmaceutical innovation and the accelerated advancement of clinically needed new drug approvals, olapaly became the first PARP inhibitor approved in China for first-line maintenance therapy of ovarian cancer.
Manuniya ga Olapali wanda FDA ta Amurka ta amince da shi
Kulawa ta farko-farko kan cutar kanjamau mai saurin barin kwaya tare da maye gurbin BRCA
Kulawa da kulawa ga marasa lafiyar manya tare da cutarwa ko ake zargi da cutarwa ta hanyar larura ko maye gurbi na BRCA (g BRCAm ko s BRCA m) a cikin marasa lafiyan da ke fama da cutar sankarar mahaifa, cutar sankarar mahaifa ko cutar kanjamau ta farko Cikakken amsa ko amsa ta bangare. Zaɓi marasa lafiya don magani bisa ga FDA ta amince da LYNPARZA mai ganewar asali.
Kulawa da kulawa da cutar sankarar jakar kwai
Don kulawa da kulawa da marasa lafiyar manya tare da cutar sankarar mahaifa, cutar sankarar mahaifa, ko cutar sankara ta farko, waɗannan marasa lafiya suna da cikakkiyar amsa ko sashi don maganin cutar kantin.
Jiyya na baya-bayan nan game da ci gaban kwayar cutar ta kwayar cutar BRCA
Don kula da marasa lafiya masu fama da cutar sankarar jakar kwai tare da cutarwa ko maye gurbi na lalacewar kwayar cutar ta BRCA (g BRCA m), sun sami 3 ko fiye da magungunan jiyya na gaba. Zaɓi marasa lafiya don magani bisa ga FDA ta amince da LYNPARZA akan ganewar asali.
BRCA maye gurbi, HER2-mummunan maganin cutar kansar nono
Jiyya na ciwon daji na nono tare da cutarwa ko ake zargi da cutar germline BRCA maye gurbi (g BRCA m), ɗan adam mai girma factor factor receptor 2 (HER2) korau, wanda aka bi da tare da neoadjuvant far, adjuvant far, ko metastatic ciwon daji. Marasa lafiya da ciwon nono waɗanda ke da masu karɓar maganin hormone (HR) tabbatacce yakamata su karɓi maganin endocrin da farko, ko kuma a yi la’akari da su ba su dace da maganin endocrine ba. Zaɓi marasa lafiya don magani bisa ga FDA ta amince da LYNPARZA ganewar asali.
Olapali is a first-in-class, oral PARP inhibitor that utilizes defects in the DNA repair pathway to preferentially kill cancer cells. This mode of action gives Olapali the potential to treat a wide range of tumors with DNA repair defects. Currently approved for ovarian cancer and breast cancer, it is expected to be quickly approved for pancreatic cancer, and has achieved excellent results in the treatment of prostate ciwon daji.
A ka'ida, manufar masu hana PARP ita ce kwayar halittar BRCA, ko an yarda da ita ta sankarar mahaifa, cutar sankarar mama, ko cutar sankara wacce ta samu goyan bayan masana na FDA, ban da kula da cutar sankarar jakar kwai da ke faruwa, ya dace da Ola Marasa lafiya na Parley suna buƙatar gano maye gurbi a cikin kwayar cutar ta BRCA kuma ba za su iya amfani da su da gani ba.
Sabili da haka, yana da matukar muhimmanci a sami rahotannin gwajin kwayoyin halitta daidai kuma masu iko kafin magani. Sai dai idan sakamakon gwajin maye gurbi na BRCA daidai ne kawai zamu iya fatan samun fa'idodin rayuwa. Cibiyoyin gwajin kwayoyin halitta a halin yanzu a kasuwa sun bambanta sosai. Vicki ya ba da shawarar cewa ku yi la'akari da amincin cibiyoyin gwajin kwayoyin halitta daga abubuwan da ke gaba.
Da farko, kayan aikin-gano kayan dole ne su zama daidai, kuma bayanan sun zama daidai!
Abu na biyu, bayanan software da ƙwarewar ƙwararru sune ainihin gasa!
Na uku, kula da inganci-girman ƙungiyar gwaji yana ƙayyade daidaitattun sakamakon gwajin!
Na huɗu, dakin gwaje-gwaje-dole ne ya sami cancantar ƙasa (ta duniya), CAP da takaddun shaida ta CLIA!
Na biyar, fitowar hukuma izini-zaɓi FDA da aka yarda da ita ita ce mafi aminci.
