Jan 2023: Adagrasib (Krazati, Mirati Therapeutics, Inc.), i-RAS GTPase family inhibitor, yanikezwa ukugunyazwa okusheshayo yi-Food and Drug Administration (FDA) ezigulini ezikhulile ezinomdlavuza we-KRAS G12C-mutated wasendaweni othuthukile noma we-metastatic non-small cell lung cancer (NSCLC), njengoba kukhonjwe ukuhlolwa okugunyazwe yi-FDA. , abaye bathola okungenani ukwelashwa okuhleliwe okukodwa kwangaphambili.
Njengokuxilonga okuhambisanayo okwengeziwe kwe-Krazati, i-FDA iphinde yagunyaza ikhithi ye-QIAGEN therascreen KRAS RGQ PCR (tissue) kanye ne-Agilent Resolution ctDx FIRST Assay (plasma). Izicubu zesimila kufanele zihlolwe uma ingekho inkomba yokuguqulwa kwesampula ye-plasma.
The KRYSTAL-1 isivivinyo somtholampilo (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.
Izilinganiso eziyinhloko zomphumela wokusebenza kahle kwakuwubude besikhathi sokuphendula kanye nezinga lokuphendula eliqinisekisiwe (ORR) ngokuhambisana ne-RECIST 1.1, njengoba ihlolwe isibuyekezo esimaphakathi esizimele esiphuphuthekisiwe (i-DOR). I-DOR emaphakathi yayiyizinyanga ezingu-8.5 (95% CI: 6.2, 13.8), kanti i-ORR yayingu-43% (95% CI: 34%, 53%).
Uhudo, isicanucanu, ukukhathala, ukuhlanza, ubuhlungu be-musculoskeletal, i-hepatotoxicity, ukukhubazeka kwezinso, i-dyspnea, i-edeema, ukuncipha kwesifiso sokudla, ukukhwehlela, inyumoniya, ukudideka, ukuqunjelwa, ubuhlungu besisu, kanye nokwelulwa kwesikhawu se-QTc kwakuyimiphumela emibi kakhulu (20%). Ukuncipha kwama-lymphocyte, ukwanda kwe-aspartate aminotransferase, ukukhuphuka kwe-sodium, ukwehla kwe-sodium, ukwehla kwe-hemoglobin, ukwanda kwe-creatinine, ukwehla kwe-albumin, ukukhuphuka kwe-alanine aminotransferase, ukwanda kwe-lipase, ukwehla kwamaplatelet, ukuncipha kwe-magnesium, nokuncipha kwe-potassium kwakuyizinto ezingavamile kakhulu zaselabhorethri (25%).
I-Adagrasib amaphilisi kufanele aphuzwe ngomlomo kabili ngosuku ngethamo lika-600 mg kuze kube yilapho isimo siqhubeka noma kukhona ubuthi obungabekezeleleki.
