Oshqozon osti bezi saratoni uchun mo'ljallangan dori, oshqozon osti bezi saratoni BRCA mutatsiyasiga qaratilgan dori olaparib (Olaparib, Liprot Lynparza) FDA ekspert yordamini oldi.
Oshqozon osti bezi saratonining kuchli invazivligi va cheklangan davolanishi tufayli so'nggi bir necha o'n yilliklarda hech qanday ilg'or terapiya joriy etilmagan va oshqozon osti bezi saratoni rivojlangan bemorlar zudlik bilan yangi samarali dori va davolash usullariga muhtoj. Jahon miqyosida oshqozon osti bezi saratonida germlin BRCA mutatsiyasining paydo bo'lishi 5-7% ni tashkil qiladi.
The targeted drug olapaly, which specifically targets BRCA mutations, has achieved excellent clinical data in the maintenance treatment of pankreatik saraton, which is enough to improve the current clinical treatment and help patients with advanced pancreatic cancer prolong their survival. 2018 yil oktyabr oyida AQSh oziq-ovqat va farmatsevtika idorasi (FDA) olapalyga etimon bezining saraton kasalligini davolash uchun etim dori berdi.
Olaparibni FBR ekspertlar qo'mitasi gBRCAm oshqozon osti bezi saratonini davolash bo'yicha qo'llab-quvvatlaydi
17 dekabr kuni AQSh Oziq-ovqat va farmatsevtika idorasi (FDA) Onkologiya Dori bo'yicha maslahat qo'mitasi (ODAC) maqsadli saratonga qarshi dori Lynparza (Xitoy brendi: Liprot, umumiy nomi) : Olaparib, olaparib)ni tasdiqlashni tavsiya qilish uchun 7 va 5 ovoz bilan ovoz berdi. Birinchi darajali parvarishlash monoterapiyasi sifatida, kamida 16 hafta davomida birinchi darajali platina kimyoterapiyasini olgandan keyin hech qanday o'zgarishlar bo'lmagan va BRCA mutatsiyasiga (gBRCAm) ega bo'lgan metastatik oshqozon osti bezi saratoni bilan og'rigan bemorlarni davolash.
sNDA taqdimoti New England Journal of Medicine jurnalida chop etilgan va Amerika Klinik Onkologiya Jamiyatining (ASCO) 3 yillik yig'ilishida chop etilgan POLO 2019-bosqich sinovining ijobiy natijalariga asoslangan. Natijalar shuni ko'rsatdiki, progressiv omon qolish (PFS) ning statistik va klinik ahamiyati sezilarli darajada yaxshilangan, bu kasallikning rivojlanishi yoki o'lim xavfini 47% ga kamaytiradi.
Olaparib BRCA mutatsiyasiga ega metastatik oshqozon osti bezi saratoniga chalingan bemorlarning progressiyasiz omon qolish vaqtini deyarli ikki baravar oshirdi (3.8 oyga nisbatan 7.4).
Olapali has been approved by the US FDA for the treatment of ovarian and ko'krak saratoni. 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 ovaryan saraton, 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.
Olapali uchun ikkita ko'rsatkich
2018 yil avgust oyida Olapali Xitoyda ro'yxatga olinib, platinaga sezgir bo'lgan tuxumdon saratonini davolash uchun ishlatiladigan tuxumdon saratoni uchun Xitoyning birinchi maqsadli dori-darmoniga aylandi (platina terapiyasidan keyingi barqaror holat, Ola Pali qayt qilish vaqtini kechiktirishi mumkin).
5 yil 2019 dekabrda, 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.
Olapali uchun ko'rsatmalar AQSh FDA tomonidan tasdiqlangan
BRCA mutatsiyasi bilan rivojlangan tuxumdonlar saratonini birinchi bosqichda davolash
Epiteliya tuxumdon saratoni, bachadon naychasi saratoni yoki qorin parda orti saratoni bilan kasallangan kattalardagi zararli germline yoki somatik BRCA mutatsiyasiga (g BRCAm yoki s BRCA m) ega bo'lgan kattalar bemorlarini parvarishlash. To'liq javob yoki qisman javob. FDA tomonidan tasdiqlangan LYNPARZA qo'shma tashxisi asosida davolanish uchun bemorlarni tanlang.
Qayta tiklanadigan tuxumdonlar saratonini davolash
Takroriy epiteliya tuxumdon saratoni, bachadon naychasi saratoni yoki qorin parda orti saratoniga chalingan kattalardagi bemorlarni davolash uchun ushbu bemorlar platinaga asoslangan kimyoterapiyaga to'liq yoki qisman javob berishadi.
Kengaytirilgan BRCA mutatsion tuxumdon saratonini postline davolash
Tuxumdon saratoni bilan kasallangan voyaga etgan bemorlarni zararli yoki gumon qilingan zararli germline BRCA mutatsiyalari (g BRCA m) bilan davolash uchun ular 3 yoki undan ortiq oldingi kimyoviy terapiyani oldilar. FDA tomonidan tasdiqlangan LYNPARZA qo'shma tashxisi asosida davolanish uchun bemorlarni tanlang.
BRCA mutatsiyasi, HER2-salbiy metastatik ko'krak bezi saratonini davolash
Neoadjuvant terapiya, yordamchi terapiya yoki metastatik saraton bilan davolangan zararli yoki shubhali zararli germline BRCA mutatsiyalari (g BRCA m), inson epidermal o'sish omili retseptorlari 2 (HER2) salbiy bilan metastatik ko'krak saratonini davolash. Gormon retseptorlari (HR) ijobiy bo'lgan ko'krak bezi saratoni bilan og'rigan bemorlar birinchi navbatda endokrin terapiyasini olishlari kerak yoki endokrin terapiya uchun yaroqsiz deb hisoblanadilar. FDA tomonidan tasdiqlangan LYNPARZA qo'shma tashxisi asosida davolanish uchun bemorlarni tanlang.
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 Prostata saratoni.
Asosan, PARP inhibitörlerinin maqsadi BRCA mutant genidir, u tasdiqlangan tuxumdonlar saratoni, ko'krak bezi saratoni yoki oshqozon osti bezi saratoni yangi FDA mutaxassislari tomonidan qo'llab-quvvatlangan, ammo takrorlanadigan tuxumdon saratonini davolash bilan bir qatorda, Ola uchun ham javob beradi. Parley bemorlari BRCA genidagi mutatsiyalarni aniqlab olishlari kerak va ularni ko'r-ko'rona foydalana olmaydilar.
Shuning uchun davolanishdan oldin aniq va ishonchli genetik test hisobotlarini olish juda muhimdir. Faqatgina BRCA gen mutatsiyasini tekshirish natijalari to'g'ri bo'lsa, biz omon qolishning afzalliklarini olishga umid qilishimiz mumkin. Hozirgi vaqtda bozorda mavjud bo'lgan genetik test muassasalari juda farq qiladi. Vikki quyidagi jihatlardan genetik tekshiruv muassasalarining ishonchliligini ko'rib chiqishni tavsiya qiladi.
Birinchidan, apparat-aniqlash uskunalari aniq bo'lishi kerak va ma'lumotlar aniq!
Ikkinchidan, dasturiy ma'lumotlar bazasi va mutaxassislarning kuchi asosiy raqobatbardoshlikdir!
Uchinchidan, sifat nazorati - sinov guruhining kattaligi test natijalarining aniqligini aniqlaydi!
To'rtinchidan, laboratoriya - milliy (xalqaro) malaka, CAP va CLIA dual sertifikatlarini olishlari shart!
Beshinchidan, rasmiy tan olinadigan FDA tomonidan tasdiqlangan genetik test yanada xavfsizroq.
