Ubar sasaran kanker pankréas, kanker pankreas mutasi BRCA sasaran ubar olaparib (Olaparib, Liprot Lynparza) nampi dukungan ahli FDA
Alatan invasiveness kuat sarta perlakuan kawates kanker pankréas, teu aya terapi terobosan geus diwanohkeun dina sababaraha dekade kaliwat, sarta penderita kanker pankréas canggih urgently merlukeun ubar anyar éféktif jeung perlakuan. Sacara global, kajadian mutasi germline BRCA dina kanker pankreas nyaéta 5-7%.
The targeted drug olapaly, which specifically targets BRCA mutations, has achieved excellent clinical data in the maintenance treatment of kanker pancreatic, which is enough to improve the current clinical treatment and help patients with advanced pancreatic cancer prolong their survival. Dina Oktober 2018, Administrasi Pangan sareng Narkoba AS (FDA) masihan olapaly pangobatan ubar yatim pikeun kanker pankreas.
Olaparib dirojong ku panitia ahli FDA pikeun pengobatan kanker pankreas gBRCAm
Dina 17 Désémber, Komite Panaséhat Narkoba Onkologi AS (FDA) milih 7 ka 5 pikeun nyarankeun persetujuan obat antikanker anu dituju Lynparza (ngaran merek Cina: Liprot, nami generik): Olaparib, olaparib), salaku monoterapi pangropéa garis kahiji, pengobatan pasien kanker pankréas métastatik anu teu aya kamajuan saatos nampi kémoterapi platinum lini kahiji sahenteuna sahenteuna 16 minggu sareng mawa mutasi BRCA germline (gBRCAm).
Kintunan sNDA dumasar kana hasil positip tina percobaan POLO fase 3 anu diterbitkeun dina New England Journal of Medicine sareng diterbitkeun dina rapat taunan 2019 American Society of Clinical Oncology (ASCO). Hasilna nunjukkeun yén signifikan statistik sareng klinis tina survival bébas kamajuan (PFS) ningkat sacara signifikan, ngirangan résiko kamajuan panyakit atanapi maot ku 47%.
Olaparib ampir dua kali kana waktos salamet bébas tina kamajuan penderita kanker pankreas metastatik kalayan mutasi BRCA (3.8 vs 7.4 bulan).
Olapali has been approved by the US FDA for the treatment of ovarian and kanker payudara. 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 kanker indung, 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.
Dua indikasi pikeun Olapali
Dina Agustus 2018, Olapali disatujuan pikeun daptar di Tiongkok, janten ubar sasaran munggaran pikeun kanker ovarium Cina, dianggo pikeun perawatan perawatan kanker ovarium berulang platinum-sénsitip (kaayaan stabil saatos terapi platinum, Ola Pali tiasa tunda waktos kambuh).
Tanggal 5 Désémber 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.
Indikasi pikeun Olapali disahkeun ku US FDA
Perawatan pangropéa garis kahiji kanker ovarium canggih kalayan mutasi BRCA
Perawatan pangropéa pikeun penderita sawawa kalayan germline ngabahayakeun atanapi disangka ngabahayakeun atanapi mutasi BRCA somatik (g BRCAm atanapi s BRCA m) di penderita sawawa kalayan kanker ovarium épitél, kanker tabung fallopian atanapi kanker peritoneal primér réspon lengkep atanapi réspon parsial. Pilih pasién pikeun pangobatan dumasar kana diagnosis anu disatujuan LYNPARZA disarengan ku FDA.
Perawatan perawatan kanker ovarium kumat
Pikeun perawatan perawatan pasién sawawa kalayan kanker ovarium épitél kumat, kanker tabung fallopian, atanapi kanker peritoneal primér, penderita ieu ngagaduhan réspon lengkep atanapi parsial kana kémoterapi basis platinum.
Perlakuan postline tina kanker ovarium mutasi BRCA anu maju
Pikeun pengobatan pasién sawawa ku kanker ovarium kalayan mutasi BRCA germline ngabahayakeun atanapi disangka ngabahayakeun (g BRCA m), aranjeunna nampi 3 atanapi langkung pangobatan kémoterapi garis payun. Pilih pasién pikeun pangobatan dumasar kana diagnosis oncomitant LYNPARZA anu disatujuan ku FDA.
BRCA mutasi, pangobatan kanker payudara metastatik HER2-négatip
Pangobatan kanker payudara métastatik kalayan mutasi BRCA germline ngabahayakeun atanapi disangka ngabahayakeun (g BRCA m), reséptor faktor pertumbuhan épidermal manusa 2 (HER2) négatip, anu parantos dirawat ku terapi neoadjuvant, terapi adjuvant, atanapi kanker métastatik. Pasién kanker payudara anu réséptor hormon (HR) positip kedah nampi terapi éndokrin heula, atanapi dianggap henteu cocog pikeun terapi éndokrin. Pilih pasien pikeun pengobatan dumasar kana diagnosis koncomitant LYNPARZA disatujuan FDA.
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 kanker prostat.
Sacara prinsip, udagan sambetan PARP nyaéta gén mutan BRCA, naha éta disatujuan kanker ovarium, kanker payudara, atanapi kanker pankreas anu nembé nampi dukungan ahli FDA, salian ti pengobatan kanker ovarium berulang, éta cocog pikeun Ola Pasién Parley kedah ngadeteksi mutasi dina gén BRCA sareng henteu tiasa nganggo éta ambing.
Ku sabab éta, penting pisan pikeun kéngingkeun laporan tés genetik anu akurat sareng otorisasi sateuacan perlakuan. Ngan upami hasil uji mutasi gen BRCA akurat, urang tiasa ngarepkeun kauntungan pikeun salamet. Institusi tés genetik anu ayeuna aya di pasar béda-béda pisan. Vicki nyarankeun yén anjeun mertimbangkeun réliabilitas lembaga tés genetik tina aspék ieu.
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Kalima, pangakuan-pilih resmi uji coba genetik anu disatujuan ku FDA langkung aman.
