Jan 2023: Adagrasib (Krazati, Mirati Therapeutics, Inc.), RAS GTPase inhibitor qoyska, ayaa la siiyay ogolaansho degdeg ah Maamulka Cuntada iyo Dawooyinka (FDA) ee bukaanada qaangaarka ah ee qaba KRAS G12C-mutated maxaliga ah ama kansarka sambabada unugyada yaryar (NSCLC), sida lagu aqoonsaday baaritaanka FDA-ansixisay , kuwaas oo helay ugu yaraan hal daawaynta habdhiska hore.
Sida baadhitaanada wehelka dheeraadka ah ee Krazati, FDA waxay kaloo ansixisay QIAGEN therascreen KRAS RGQ PCR kit (unug) iyo Xallinta Agilent ctDx FIRST Assay (plasma). Unugyada burooyinka waa in la baaro haddii aysan jirin calaamad muujinaysa isbeddel ku yimi muunadda balaasmaha.
The KRYSTAL-1 tijaabada caafimaadka (NCT03785249), which involved patients with locally advanced or metastatic NSCLC with KRAS G12C mutations, served as the foundation for the approval. Efficacy was assessed in 112 individuals whose illness had advanced during or after receiving immune checkpoint inhibitors and platinum-based chemotherapy, either concurrently or sequentially. Patients got adagrasib 600 mg twice daily until their condition progressed or the side effects became intolerable.
Tallaabooyinka natiijada waxtarka aasaasiga ah waxay ahaayeen muddada jawaabta iyo heerka jawaabta ujeeddada la xaqiijiyay (ORR) si waafaqsan RECIST 1.1, sida lagu qiimeeyay dib u eegista dhexe ee madax-bannaan ee indhoolaha ah (DOR). Dhexdhexaadka DOR wuxuu ahaa 8.5 bilood (95% CI: 6.2, 13.8), iyo ORR wuxuu ahaa 43% (95% CI: 34%, 53%).
Shuban, lallabbo, daal, matag, muruq xanuun, hepatotoxicity, kelyaha daciifka ah, dyspnea, edoema, rabitaanka cuntada oo yaraada, qufaca, oof-wareen, wareer, calool-istaag, calool xanuun, iyo muddada dheer ee QTc ayaa ahaa dhibaatooyinka soo noqnoqda (20%). lymphocytes oo yaraada, aminotransferase aspartate oo kordhay, sodium oo kordhay, hoos u dhaca sodium, hoos u dhaca haemoglobin, creatinine oo kordhay, hoos u dhaca albumin, korodhka alanine aminotransferase, lipase kordhay, platelets oo yaraada, hoos u dhaca magnesium, iyo hoos u dhaca potassium ayaa ah kuwa ugu badan ee aan caadiga ahayn ee shaybaarka (25%).
Adagrasib Kiniinada waa in afka laga qaataa laba jeer maalintii iyadoo la qaadanayo qiyaasta 600 mg ilaa xaaladdu ka sii socoto ama ay jirto sun aan loo dulqaadan karin.
