August 20, 2021: Dhawaan bishii Maajo, 2021 Lumakras (sotorasib) waxaa ansixiyay guddiga Maamulka Cuntada iyo Dawooyinka ee Mareykanka sida daawaynta ugu horeysa ee bukaanada qaangaarka ah ee qaba kansarka sanbabada unugyada aan yareyn ee lagu sameeyay ugu yaraan hal daawaynta habdhiska hore oo burooyinkooda ay leeyihiin nooc gaar ah oo isbeddel hidde ah oo loo yaqaan KRAS G12C. Tani waa daawaynta ugu horraysa ee la bar tilmaameedsado ee loo oggolaado malignancies oo leh isbeddel kasta oo KRAS ah, kaas oo ka dhigan qiyaastii 25% isbeddellada kansarka sambabada unugyada aan yaryarayn. Burooyinka sambabada unug yar-yar, KRAS G12C waxay ku xisaabtamaan qiyaastii 13% dhammaan isbeddellada.
"Isbeddellada KRAS ayaa muddo dheer loo tixgeliyey inay u adkaysanayaan daaweynta daroogada, taasoo ka dhigan baahida dhabta ah ee aan la daboolin ee bukaannada qaba noocyada kansarka qaarkood," ayuu yiri Richard Pazdur, MD, oo ah agaasimaha Xarunta Sare ee Oncology ee FDA iyo ku-simaha agaasimaha Xafiiska Cudurada Oncologic ee Xarunta FDA ee Qiimaynta Dawooyinka iyo Cilmi-baarista. "Oggolaanshaha maanta waxay ka dhigan tahay tallaabo muhiim ah oo loo qaaday mustaqbalka halkaas oo bukaanno badan ay yeelan doonaan hab daawaynta shakhsi ahaaneed."
The genetic abnormalities that cause kansarka sanbabada, the most prevalent cancer type with the greatest fatality rate, can be roughly classified. KRAS is a mutation that affects a collection of genes involved in cell development and division.
In a study of 124 patients with KRAS G12C-mutated kansarka sanbabada ee aan yareyn who had progressed after receiving an immune checkpoint inhibitor and/or platinum-based chemotherapy, researchers looked at the efficacy of Lumakras. The objective response rate (the percentage of patients whose tumours are eradicated or decreased) and the duration of response were the two main outcomes assessed. The objective response rate was 36%, with 58 percent of patients reporting a six-month or longer duration of response.
Qiyaasta 960 mg ayaa la ansixiyay iyadoo lagu salaynayo caddaymaha caafimaad ee la heli karo iyo sidoo kale qaabaynta farmacokinetic iyo farmacodynamic ee taageeray qiyaasta. Dawladdu waxay dalbanaysaa tijaabo suuq-geyneed ka dib taasoo qayb ka ah qiimaynta oggolaanshahan la dedejiyey si loo eego haddii qiyaasta hoose ay yeelan doonto saameyn daweyn oo la mid ah.
Shuban, murqo xanuun, lallabbo, daal, dhaawac beerka, iyo qufaca ayaa ah saamaynta xun ee Lumakras ee ugu badan. Lumakras waa in laga fogaadaa haddii bukaanadu muujiyaan calaamadaha cudurka sambabada interstitial, waana in gabi ahaanba la joojiyo haddii cudurka la ogaado. Kahor inta aan la bilaabin iyo marka la isticmaalayo Lumakras, dhakhaatiirta daryeelka caafimaadku waa inay qiimeeyaan imtixaanada shaqada beerka bukaanka. Lumakras waa in la hakiyo, la dhimo qiyaasta, ama si buuxda loo joojiyo haddii bukaanku uu yeesho dhaawac beerka ah. Marka ay qaadanayaan Lumakras, bukaanku waa in ay iska ilaaliyaan qaadashada daawooyinka aashitada-yareeya, daawooyinka keena ama substrates ee enzymes beerka qaarkood, iyo daawooyinka kuwaas oo ah substrates P-glycoprotein.
Lumakras waxaa lagu ansixiyay iyada oo loo marayo Waddada Ansixinta Degdegga ah ee FDA, taas oo u oggolaanaysa hay'adda in ay ansixiso daawooyinka cudurrada halista ah halkaas oo ay jirto baahi caafimaad oo aan la daboolin iyo daaweynta ayaa la muujiyay in ay leedahay saameyno gaar ah oo si caddaalad ah u saadaaliyay faa'iidada bukaan-socodka ee bukaanka. Cilmi baaris dheeraad ah ayaa loo baahan yahay si loo xaqiijiyo loona qeexo faa'iidooyinka caafimaad ee Lumakras '
Codsigan waxa uu FDA ka helay Track Track, Mudnaanta Mudnaanta, iyo Daawaynta Horumarka.
Lumakras waxa kale oo loo qoondeeyey sida Daroogada Agoonta ah, taas oo ku siinaysa dhiirigelin dhaqaale si ay u caawiso oo ay u kiciso horumarinta daaweynta xanuunada dhifka ah.
Mashruuca Orbis, oo ah FDA Oncology Center of Excellence, ayaa loo isticmaalay in lagu sameeyo dib u eegistan. Mashruuca Orbis wuxuu u abuuraa hannaan la-hawlgalayaasha adduunka oo dhan si ay u soo gudbiyaan oo ay dib ugu eegaan dawooyinka kansarka isku mar. FDA waxay kala shaqeysay Maamulka Alaabta Therapeutic (TGA) ee Australia, Hay'adda Sharciyeynta Caafimaadka Brazil (ANVISA), Caafimaadka Kanada, iyo Hay'adda Sharciyeynta Alaabada Dawooyinka iyo Caafimaadka ee dib u eegistan (MHRA; Boqortooyada Ingiriiska). Hay'adaha kale ee sharciyaynta ayaa wali dib u eegaya codsiyada.
Amgen Inc. wuxuu helay oggolaanshaha FDA ee Lumakras.
Lumakras oo ay weheliso Lumakras, FDA waxay ansixisay qalabka QIAGEN therascreen KRAS RGQ PCR (oo ay ansixisay QIAGEN GmbH) iyo Guardant360 CDx (oo ay caddeeyeen Guardant Health, Inc.) sida baadhitaanada wehelka Lumakras. Si loo qiimeeyo haddii Lumakras ay tahay daawaynta ku habboon bukaanka, tijaabada QIAGEN GmbH waxay falanqaynaysaa unugyada burooyinka iyo Guardant Health, Inc. Haddii aan wax isbeddel ah laga helin muunadda balaasmaha, buro bukaanku waa in la qiimeeyaa.
source: https://www.fda.gov/
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