Agasti 2021: I-FDA inikeze imvume esheshayo ku sotorasib (Lumakras TM, Amgen, Inc.), i-RAS GTPase family inhibitor, yeziguli ezikhulile ezine-KRAS G12C eguqukile endaweni noma umdlavuza wamaphaphu we-metastatic non-small cell lung (NSCLC) ezithole okungenani ukwelashwa okuhleliwe okukodwa kwangaphambili, njengoba kunqunywa ukuhlolwa okugunyazwe yi-FDA.
Njengokuxilongwa okuhambisana neLumakras, i-FDA ivume ikhithi (izicubu) zeQIAGEN therascreen® KRAS RGQ PCR (ne-tissue) ne-Guardant360® CDx (plasma). Izicubu zesimila kufanele zihlolwe uma kungenakuguqulwa kwezakhi ezitholakala kusampula le-plasma.
Ukugunyazwa bekusekelwe ku-CodeBreaK 100, ucwaningo lomtholampilo olugxile ezintweni eziningi, olungalo olulodwa, ngelebula evulekile (NCT03600883) olwaluhlanganisa iziguli ezinezinguquko ze-KRAS G12C ezazithuthuke endaweni noma i-NSCLC ye-metastatic. Ukusebenza komuthi kwahlolwa ezigulini eziyi-124 isifo sazo sase siqhubekele phambili noma ngemva kwalokho okungenani ukwelashwa okuhleliwe okukodwa kwangaphambili. I-Sotorasib 960 mg ngomlomo kanye ngosuku yanikezwa iziguli kuze kube yilapho isifo sikhula noma ubuthi obungabekezeleleki.
Imiphumela yokusebenza okuyisisekelo bekuyizinga lokuphendula elihlosiwe (i-ORR) ngokuya nge-RECIST 1.1, njengoba kunqunywe ukubuyekezwa okuzimele okuyimpumputhe, nobude bempendulo. Ngesikhathi sokuphendula esiphakathi kwezinyanga eziyi-10 (ububanzi 1.3+, 11.1), i-ORR ibingamaphesenti angama-36 (amaphesenti angama-95 we-CI: amaphesenti angama-28, amaphesenti angama-45).
Uhudo, ubuhlungu bemisipha, isicanucanu, ukukhathala, i-hepatotoxicity, nokukhwehlela kwakuyimiphumela emibi kakhulu (20%). Ukwehla kwama-lymphocyte, kwehle i-hemoglobin, kukhuphuka i-aspartate aminotransferase, kukhuphuka i-alanine aminotransferase, kwehla i-calcium, kukhuphuka i-alkaline phosphatase, kukhuphuka amaprotheni omchamo, futhi kwehliswa isodiyamu kwakuyizinto ezazivame ukwedlula zonke zaselabhorethri (amaphesenti angama-25).
I-Sotorasib ithathwa kanye ngosuku, noma ngaphandle kokudla, ngomthamo ka-960 mg.
Umthamo we-960 mg uvunyelwe ngokususelwa kubufakazi obutholakalayo bomtholampilo kanye nokufaniswa kwe-pharmacokinetic kanye ne-pharmacodynamic esekela inani. I-FDA ifuna ukuhlolwa kwe-postmarketing njengengxenye yokuhlolwa kwalokhu kuvunywa okusheshisiwe ukubona ukuthi ngabe umthamo ophansi uzoba nomphumela ofanayo wokwelapha.
Inkomba: https://www.fda.gov/
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