Ua hoʻolaha ʻo Servier i kēia lā ua ʻae ka US Food and Drug Administration (FDA) i ka hui hou ʻana i ka New Drug Application (sNDA) no TIBSOVO® (ivosidenib tablets) ma ke ʻano he lapaʻau kūpono no nā poʻe maʻi me ka IDH1-mutated acute myeloid leukemia (AML). Ua hāʻawi ʻia ka sNDA i ka Priority Review, ka mea e hoʻolalelale i ka loiloi a hōʻemi i ka pahuhopu manawa loiloi mai 10 mahina a i 6 mahina. Hāʻawi ʻia ka Manaʻo Nui i nā lāʻau lapaʻau e hāʻawi i nā holomua nui i ka mālama ʻana a i ʻole e hāʻawi i kahi lapaʻau inā ʻaʻohe lāʻau lapaʻau kūpono.
"Ma nā kuʻekuʻe wāwae o kā mākou FDA i ʻae ʻia ʻo TIBSOVO i cholangiocarcinoma, hauʻoli mākou i kēia hana koʻikoʻi i mua i ka noʻonoʻo ʻana o ke keʻena e hoʻonui i kāna hōʻailona o kēia manawa e hoʻokomo i ka mālama ʻana i nā maʻi me ka IDH1-mutated acute myeloid leukemia ma mua. K. Lee, Luna Nui, Servier Pharmaceuticals. "ʻOliʻoli mākou i ka manawa kūpono o kēia papahana ke hoʻomau nei mākou i ka ulu ʻana i kā mākou alakaʻi i ka oncology a hāʻawi i nā lāʻau lapaʻau e hoʻololi i ke ola i nā poʻe maʻi e noho nei me nā maʻi maʻi paʻakikī."
Kākoʻo ʻia ka ʻae ʻana o ka sNDA e nā hopena mai ke aʻo ʻana ʻo AGILE, kahi hoʻāʻo honua, Phase 3 i nā maʻi me ka IDH1-mutated AML i mālama ʻole ʻia, i hōʻike ʻia ma ka 2021 American Society of Hematology Annual Meeting and Exposition. Ua hōʻike ka ʻikepili i ka hoʻomaʻamaʻa ʻana me TIBSOVO i hui pū ʻia me azacitidine i hoʻomaikaʻi nui ʻia ke ola ola ʻole hanana (EFS) (hazard ratio [HR] = 0.33, 95% CI 0.16, 0.69, 1-sided P = 0.0011 1,2). Eia kekahi,ʻo ka hui pūʻana o TIBSOVO me azacitidine i hōʻike i ka hoʻomaikaʻi nuiʻana o ka helu i ke ola holoʻokoʻa (OS) (HR = 0.44 [95% CI 0.27, 0.73]; 1-sided P = 0.0005), me ka median OS o 24.0 mahina.
"ʻO TIBSOVO ka lāʻau lapaʻau mua e kuhikuhi ana i ka metabolism maʻi kanesa e hōʻike i ka hoʻomaikaʻi ʻana i ke ola ʻole o ka hanana a me ke ola holoʻokoʻa i hui pū ʻia me azacitidine i nā poʻe maʻi me ka IDH1-mutated AML i mālama ʻole ʻia ma mua," wahi a Susan Pandya, MD, Hope Pelekikena Clinical Development a me ke poʻo o ka Cancer Metabolism Global Development Oncology & Immuno-Oncology, Servier Pharmaceuticals. "Me kēia ʻae FDA no ka Priority Review, ua kokoke mākou i ka hāʻawi ʻana i kēia koho koʻikoʻi koʻikoʻi i nā maʻi ma US a ke kakali nei mākou i ke komo ʻana me nā ʻoihana hoʻoponopono a puni ka honua."
Ua ʻae ʻia ʻo TIBSOVO[*] i ka US ma ke ʻano he monotherapy no ka mālama ʻana i nā pākeke me ka IDH1-mutant relapsed a refractory acute myeloid leukemia (AML), a no nā pākeke me ka IDH1-mutant AML i ʻike hou ʻia he ≥75 mau makahiki a i ʻole i loaʻa. nā comorbidities e pale ana i ka hoʻohana ʻana i ka chemotherapy induction intensive. I kēia mau lā, ua ʻae ʻia ʻo TIBSOVO ma ke ʻano he lāʻau lapaʻau mua a hoʻopaʻa wale ʻia no nā poʻe maʻi me ka IDH1-mutated cholangiocarcinoma i mālama mua ʻia.
I ka hoʻāʻo ʻana e lawe i nā koho lapaʻau hou i nā poʻe maʻi e noho ana me nā maʻi maʻi paʻakikī, ua hana ʻo Servier i mea nui ma ka honua holoʻokoʻa, a hoʻokaʻawale ʻoi aku ma mua o 50% o kāna kālā noiʻi a me ka hoʻomohala ʻana i ka noiʻi maʻi maʻi. Me ka ʻoi aku o 21 mau waiwai oncology ma nā ʻano like ʻole o ka hoʻomohala ʻana i ke olakino, a me 20 mau papahana noiʻi e hoʻomau nei, ua kūpaʻa ʻo Servier i ka ʻimi ʻana i nā hoʻonā e hoʻoponopono ai i nā pono o ka maʻi ma waena o ke ʻano holoʻokoʻa o ka maʻi a me nā ʻano ʻano maʻi maʻi.
