Ubat sasaran kanser pankreas, ubat sasaran mutasi BRCA olaparib (Olaparib, Liprot Lynparza) menerima sokongan pakar 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. Di peringkat global, kejadian mutasi BRCA kuman pada barah pankreas adalah 5-7%.
The targeted drug olapaly, which specifically targets BRCA mutations, has achieved excellent clinical data in the maintenance treatment of barah pankreas, which is enough to improve the current clinical treatment and help patients with advanced pancreatic cancer prolong their survival. Pada bulan Oktober 2018, Pentadbiran Makanan dan Dadah AS (FDA) memberikan olapaly rawatan ubat yatim untuk barah pankreas.
Olaparib disokong oleh jawatankuasa pakar FDA untuk rawatan barah pankreas gBRCAm
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%.
Olaparib hampir menggandakan masa kelangsungan hidup bebas perkembangan pesakit dengan barah pankreas metastatik dengan mutasi BRCA (3.8 vs 7.4 bulan).
Olapali has been approved by the US FDA for the treatment of ovarian and kanser 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 kanser ovari, 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 petunjuk untuk Olapali
Pada bulan Ogos 2018, Olapali telah diluluskan untuk disenaraikan di China, menjadi ubat sasaran pertama untuk kanser ovari, yang digunakan untuk rawatan rawatan kanser ovari berulang sensitif platinum (keadaan stabil selepas terapi platinum, Ola Pali dapat melambatkan masa untuk kambuh).
Pada Disember 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.
Petunjuk untuk Olapali yang diluluskan oleh FDA AS
Rawatan perawatan pertama barah ovari maju dengan mutasi BRCA
Rawatan penyelenggaraan untuk pesakit dewasa dengan barisan kuman berbahaya atau disyaki mutasi BRCA somatik (g BRCAm atau s BRCA m) pada pesakit dewasa dengan barah ovari epitel, barah tiub fallopi atau barah peritoneal primer Tindak balas lengkap atau tindak balas separa. Pilih pesakit untuk mendapatkan rawatan berdasarkan diagnosis bersama LYNPARZA yang diluluskan oleh FDA.
Rawatan penyelenggaraan barah ovari berulang
Untuk rawatan rawatan pesakit dewasa dengan barah ovari epitel berulang, barah tiub fallopi, atau barah peritoneal primer, pesakit ini mempunyai tindak balas lengkap atau separa terhadap kemoterapi berasaskan platinum.
Rawatan selepas barah kanser ovari mutasi BRCA lanjut
Untuk rawatan pesakit dewasa dengan barah ovari dengan mutasi BRCA kuman yang berbahaya atau disyaki berbahaya (g BRCA m), mereka telah menerima 3 atau lebih rawatan kemoterapi garis depan. Pilih pesakit untuk mendapatkan rawatan berdasarkan diagnosis LYNPARZA yang diluluskan oleh FDA.
Mutasi BRCA, rawatan barah payudara metastatik HER2-negatif
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 kanser prostat.
Pada prinsipnya, sasaran perencat PARP adalah gen mutan BRCA, sama ada kanser ovari yang disetujui, barah payudara, atau barah pankreas yang baru saja mendapat sokongan pakar FDA, selain rawatan barah ovari yang berulang, ia sesuai untuk Ola Pesakit parley perlu mengesan mutasi pada gen BRCA dan tidak dapat menggunakannya secara membuta tuli.
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.
Pertama, perkakasan-peralatan pengesanan mesti tepat, dan datanya tepat!
Kedua, pangkalan data perisian dan kekuatan ahli adalah daya saing teras!
Ketiga, kawalan kualiti-ukuran pasukan ujian menentukan ketepatan keputusan ujian!
Keempat, makmal-mesti mendapat kelayakan nasional (antarabangsa), sijil dua kali CAP dan CLIA!
Kelima, pengujian rasmi-memilih ujian genetik yang diluluskan oleh FDA lebih selamat.
