Ma Pepeluali 15, 2022, ua ʻae ka US Food and Drug Administration (FDA) i ka adagrassib new drug application (NDA) no ka mālama ʻana i nā poʻe maʻi me ka maʻi maʻi ʻaʻai liʻiliʻi liʻiliʻi liʻiliʻi (NSCLC) me KRAS G12C mutation i loaʻa ma ka liʻiliʻi hoʻokahi systemic. lapaʻau ma mua.Ma lalo o ke kānāwai uku hoʻohana lāʻau lapaʻau, e hoʻoholo nā regulators e noi a hiki i Dekemaba 14, 2022.
Ma mua, i ka mahina ʻo Iune 2021, ua hāʻawi ka US FDA i ka hōʻoia ʻana o ka adagrassib breakthrough therapy no ka mālama ʻana i nā mea maʻi me ka mālama ʻana i ka maʻi maʻi ʻaʻai liʻiliʻi liʻiliʻi e lawe ana i ka mutation KRAS G12C.
ʻO Adagrassib kahi mea hoʻopaneʻe KRAS G12C waha me ka kikoʻī kiʻekiʻe.Hoʻopaʻa paʻa ʻole ia i KRAS G12C a hoʻopaʻa iā ia i kahi kūlana ʻole.He lōʻihi ka hapalua o ke ola e hiki ai ke hoʻokō i ka pale KRAS mau loa a alakaʻi i ka hana antitumor hohonu a mau loa.
inoa maʻamau: adagrassib
Code: mrtx849
Pahuhopu: KRAS G12C
ʻApono mua ʻia ma ʻAmelika Hui Pū ʻIa: ʻaʻole i ʻae ʻia
ʻApono mua ʻia ma Kina: ʻaʻole i ʻae ʻia
MʻAʻohe Raw Material: (R)-3-HYDROXYMETHYL-PIPERAZINE-1-CARBOXYLIC ACID TERT-BUTYL ESTER (CAS: 278788-66-2)
Ka hopena
Ua ʻike ʻia he paʻakikī ka hoʻololi ʻana o KRAS a loaʻa nā koho lapaʻau i ka mōʻaukala, ʻoi aku ka pili o nā biomarkers KRAS G12C me nā hopena ola maikaʻi ʻole.I kēia manawa, ʻo ka loiloi a ka FDA i ka noi lāʻau hou a adagrassib e hōʻailona i ka holomua nui i ka hāʻawi ʻana i nā koho hou a i koho ʻia no nā maʻi maʻi KRAS G12C mutant NSCLC.
Kumu kuhikuhi:
https://www.onclive.com
https://ir.mirati.com
Ka manawa hoʻouna: Apr-11-2022