By recent standards, the first quarter of 2024 has been relatively slow in terms of novel drug approvals. Only 10 new drugs were granted authorization in the first three months of the year (Tablel). This compares to 13 in the first quarter of 2023 -a figure that was equalled or best...
[1] https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-osimertinib-chemotherapy-egfr-mutated-non-small-cell-lung-cancer [2] Planchard D, Jänne PA, Cheng Y, Yang JC, Yanagitani N, Kim SW, Sugawara S, Yu Y, Fan Y, Geater SL, Laktionov K, Lee CK, Valdiviezo...
2024年6月14日 美国食品药品监督管理局(FDA)批准贝林妥欧单抗(blinatumomab)用于在多期化疗的巩固阶段治疗的CD19阳性费城染色体阴性前体B细胞急性淋巴细胞白血病(ph阴性BCP ALL)的成人、儿童(≥1个月)和老年患者。 详情请戳:FDA更新 | FDA批准贝林妥欧单抗作为CD19阳性费城染色体阴性前体B细胞急性淋巴细胞白血病的巩固...
originally enacted in 1992. PDUFA allows the FDA to access more resources to quicken the drug approval process. Many important drugs have been approved through PDUFA, including medicines for cancer, AIDS and heart disease.
1.https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2023 2.https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/2023-biological-license-application-a...
不良反应:眼部疾病、疲劳、恶心、头痛和食欲不振等。 REF: 1.https://www.targetedonc.com/fda-briefs/march-2024 2.https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zanubrutinib-relapsed-or-refractory-follicular-lymphoma...
1.https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2023 2.https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/2023-biological-license-application-approvals ...
参考文献: Huseyin Naci, et al., Overall survival benefits of cancer drugs initially approved by the US Food and Drug Administration on the basis of immature survival data: a retrospective analysis, Lancet Oncol. 2024. ...
结果显示,Capivasertib-氟维司群组的中位 PFS为7.3个月,安慰剂-氟维司群组为3.1个月(HR=0.50,p值< 0.0001)。 资料来源: FDA官网 https://endpts.com/every-fda-drug-approval-from-2023-full-list-of-approved-new-drugs/
2024年9月12日,一款皮下注射的PD-(L)1抑制剂——Tecentriq Hybreza,获美国食品药品监督管理局(FDA)批准,它是首个也是目前唯一一个皮下抗PD-(L)1癌症免疫疗法。此前该药已于2023年8月,在英国获得首次全球批准,目前已在50多个国家/地区获批上市。