2023年7月6日被FDA以传统方式批准上市。 2023年美国FDA批准的新生物药中最抢眼的无疑是Talvey、Elrexfio、Epkinly、Columvi四个治疗血液瘤的动用T细胞的双抗。在与治疗同样适应症的CAR-T的竞争中,这四个双抗都是现货型药物且容易产业化,且不具有像CAR-T那样高的细胞因子释放综合征毒性及神经毒性。这四个双抗...
这项研究共纳入了187名对至少1种PI、1种IMiD和1种抗CD38单克隆抗体耐药的多发性骨髓瘤患者。其中关键队列A共有123名未接受过BCMA定向治疗的患者,总体缓解率(ORR)高达57.7%,完全缓解率为25.8%;队列B由64名之前接受过BCMA靶向抗体药物偶联物或CAR-T细胞疗法的患者组成,总体缓解率(ORR)为33.3%,9个月DOR率为84.3...
2023年美国FDA批准的新生物药中最抢眼的无疑是Talvey、Elrexfio、Epkinly、Columvi四个治疗血液瘤的动...
WASHINGTON --Opening a new era in cancer care, the Food and Drug Administration on Wednesday approved the first treatment that genetically engineers patients' own blood cells into an army of assassins to seek and destroychildhood leukemia. TheCAR-T cell treatment developed by Novartisand the Univer...
2023年,FDA共批准了15款肿瘤创新药,包括4款双抗新药、5款单抗及多肽类药物、6款小分子药物。多个全新靶点及全新机制药物获批上市,如首个AKT抑制剂、首个口服SERD抑制剂及首个可逆BTK抑制剂等。 其中,多款国产肿瘤创新药成功登陆美国市场,如和黄医药的呋喹替尼、君实生物的特瑞普利单抗、亿帆医药的艾贝格司亭α注...
This marks the only CAR T-cell therapy approved by the FDA for 4 subtypes of non-Hodgkin lymphoma. FDA Approves Liso-Cel for Relapsed/Refractory Mantle Cell Lymphoma The FDA approved lisocabtagene maraleucel (liso-cel; Breyanzi) for the treatment of adult patients with relapsed or refractory...
with the PDUFA date goal date set as August 19, 2022. bluebird is expecting an FDA advisory committee meeting in June 2022 before the approval decision. If the product is approved by the FDA under the current schedule, it could potentially be the first lentiviral vector gene therapy for patie...
BMS’ CAR T Cell Therapy Breyanzi Approved by the FDA for Relapsed or Refractory Follicular Lymphoma
The investigational new drug application of IMC001, an EpCAM-targeting autologous CAR T-cell therapy for infusion, has been accepted by the FDA for the treatment of patients with EpCAM-positive advanced gastrointestinal tumors, including gastric cancer, gastroesophageal junction (GEJ) adenocarcinoma, ...
Does anyone know of a list of materials, plastics and metals that are approved by FDA, a kind of a positive list? Best regards, Tommy Denmark Replies continue below Recommended for you Occupant Safety And Biomechanics Realistic Simulation Probes Biomechanics of Knees FDA approved material for...