Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.
Clin Drug Investig. 2021 Sep;41(9):825-828. doi: 10.1007/s40261-021-01065-y. Epub 2021 Aug 4.
FKB238 is a biosimilar of bevacizumab (a monoclonal antibody against vascular endothelial growth factor) approved for use in the same types of cancer as reference bevacizumab. FKB238 has similar physicochemical and pharmacodynamic properties to those of reference bevacizumab and pharmacokinetic similarity was shown in healthy volunteers and in patients with non-small cell lung cancer (NSCLC). FKB238 demonstrated equivalent clinical efficacy to reference bevacizumab in patients with advanced or recurrent nonsquamous NSCLC, with similar tolerability, safety and immunogenicity profiles.
FKB238 是贝伐珠单抗(一种针对血管内皮生长因子的单克隆抗体)的生物类似药,获批用于与参照贝伐珠单抗相同类型的癌症。FKB238 在理化性质和药效动力学方面与参照贝伐珠单抗相似,在健康志愿者和非小细胞肺癌(NSCLC)患者中显示出药代动力学相似性。FKB238 在晚期或复发性非鳞状 NSCLC 患者中的临床疗效与参照贝伐珠单抗相当,具有相似的耐受性、安全性和免疫原性特征。