Isidakamizwa esihloselwe umdlavuza we-pancreatic, umdlavuza we-pancreatic BRCA ukuguqulwa kwesidakamizwa okuhloswe ngaso i-olaparib (i-Olaparib, i-Liprot Lynparza) ithole ukwesekwa kochwepheshe be-FDA
Due to the strong invasiveness and limited treatment of pancreatic cancer, no breakthrough therapy has been introduced in the past few decades, and patients with advanced pancreatic cancer urgently need effective new drugs and treatments. Emhlabeni jikelele, izehlakalo zokuguqulwa kwegciwane le-BRCA kumdlavuza we-pancreatic zingama-5-7%.
The targeted drug olapaly, which specifically targets BRCA mutations, has achieved excellent clinical data in the maintenance treatment of umdlavuza pancreatic, which is enough to improve the current clinical treatment and help patients with advanced pancreatic cancer prolong their survival. Ngo-Okthoba 2018, i-US Food and Drug Administration (FDA) yanikeza i-olapaly imithi yokwelapha intandane yomdlavuza we-pancreatic.
I-Olaparib isekelwa ikomidi lochwepheshe le-FDA ekwelapheni umdlavuza we-gBRCAm pancreatic
On December 17, the U.S. Food and Drug Administration (FDA) Oncology Drug Advisory Committee (ODAC) voted 7 to 5 to recommend the approval of the targeted anticancer drug Lynparza (Chinese brand name: Liprot, generic name) : Olaparib, olaparib), as a first-line maintenance monotherapy, treatment of patients with metastatic pancreatic cancer who has no progress after receiving first-line platinum chemotherapy for at least 16 weeks and carries a germline BRCA mutation (gBRCAm).
The sNDA submission is based on the positive results of the POLO phase 3 trial published in the New England Journal of Medicine and published at the 2019 American Society of Clinical Oncology (ASCO) annual meeting. The results showed that the statistical and clinical significance of progression-free survival (PFS) was significantly improved, reducing the risk of disease progression or death by 47%.
I-Olaparib icishe yaphinda kabili isikhathi sokusinda esingenalo ukuqhubeka kweziguli ezinomdlavuza we-metastatic pancreatic ngokuguqulwa kwe-BRCA (3.8 vs 7.4 izinyanga).
Olapali has been approved by the US FDA for the treatment of ovarian and umdlavuza webele. 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 umdlavuza wesibeletho, 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.
Izinkomba ezimbili ze-Olapali
Ngo-Agasti 2018, i-Olapali yagunyazwa ukuthi ifakwe ohlwini e-China, yaba umuthi wokuqala e-China okuhloswe ngawo umdlavuza wesibeletho, osetshenziselwa ukwelapha umdlavuza we-ovarian ophindelelayo ozwela i-platinum (isimo esizinzile ngemva kokwelashwa nge-platinum, u-Ola Pali angabambezela isikhathi sokuphinde abuyele emuva).
NgoDisemba 5, 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.
Izinkomba ze-Olapali ezigunyazwe yi-US FDA
Ukwelashwa kokulondolozwa komugqa wokuqala komdlavuza we-ovarian oseqophelweni eliphezulu ngokuguqulwa kwe-BRCA
Ukwelashwa kwesondlo kweziguli zabantu abadala ezinokuguqulwa kwegciwane eliyingozi noma okusolwa ukuthi kuyingozi noma i-somatic BRCA (g BRCAm noma s BRCA m) ezigulini ezikhulile ezinomdlavuza we-epithelial ovarian, umdlavuza weshubhu le-fallopian noma umdlavuza oyinhloko we-peritoneal Ukusabela okuphelele noma impendulo engaphelele. Khetha iziguli ukuze zelashwe ngokusekelwe ekuhlolweni okuhambisanayo kwe-LYNPARZA okugunyazwe yi-FDA.
Ukwelashwa kwesondlo somdlavuza we-ovarian ophindaphindiwe
Ukuze uthole ukwelashwa okulungile kweziguli ezikhulile ezinomdlavuza we-ovarian we-epithelial, umdlavuza we-fallopian tube, noma umdlavuza oyinhloko we-peritoneal, lezi ziguli zinempendulo ephelele noma ingxenye ye-chemotherapy esekelwe ku-platinum.
Ukwelashwa kwe-postline komdlavuza we-ovarian oguquguqukayo we-BRCA othuthukisiwe
Ekwelapheni iziguli ezikhulile ezinomdlavuza wesibeletho ezinokuguqulwa kwamagciwane okuyingozi noma okusolwa ukuthi kuyingozi ye-BRCA (g BRCA m), zithole ukwelashwa ngamakhemikhali oku-3 noma ngaphezulu okuphambili. Khetha iziguli ukuze zelashwe ngokusekelwe ekuhlolweni kwe-LYNPARZA okugunyazwe yi-FDA.
Ukuguqulwa kwe-BRCA, ukwelashwa komdlavuza webele we-metastatic we-HER2-negative
Treatment of metastatic breast cancer with harmful or suspected harmful germline BRCA mutations (g BRCA m), human epidermal growth factor receptor 2 (HER2) negative, which has been treated with neoadjuvant therapy, adjuvant therapy, or metastatic cancer . Patients with breast cancer who are hormone receptor (HR) positive should receive endocrine therapy first, or be considered unsuitable for endocrine therapy. Select patients for treatment based on the FDA approved LYNPARZA concomitant diagnosis.
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 umdlavuza wendlala.
Empeleni, okuhlosiwe kwe-PARP inhibitors wufuzo oluguquguqukayo lwe-BRCA, noma ngabe uvunyiwe umdlavuza we-ovarian, umdlavuza webele, noma umdlavuza we-pancreatic osanda kuthola ukwesekwa kochwepheshe be-FDA, ngaphezu kokwelashwa komdlavuza we-ovarian ophindaphindayo, ilungele i-Ola. Iziguli ze-Parley zidinga ukuthola ukuguqulwa kofuzo lwe-BRCA futhi azikwazi ukuzisebenzisa ngokungaboni.
Therefore, it is very important to obtain accurate and authoritative genetic test reports before treatment. Only if the BRCA gene mutation test results are accurate can we hope to obtain the benefits of survival. The genetic testing institutions currently on the market vary greatly. Vicki recommends that you consider the reliability of genetic testing institutions from the following aspects.
Okokuqala, i-Hardware-imishini yokuhlonza kufanele inembe, futhi idatha inembile!
Okwesibili, i-software-database namandla ochwepheshe kuwukuncintisana okuyinhloko!
Okwesithathu, ukulawulwa kwekhwalithi-usayizi weqembu lokuhlola unquma ukunemba kwemiphumela yokuhlolwa!
Okwesine, ilabhorethri-kufanele ithole iziqu zikazwelonke (zamazwe ngamazwe), i-CAP kanye nezitifiketi ezimbili ze-CLIA!
Okwesihlanu, ukuqashelwa okusemthethweni-khetha i-FDA ukuhlolwa kofuzo kuvikeleke kakhulu.
