联合用药化疗药物美国FDA于2021年4月16日批准布迈施贵宝公司(Bristol-Myers Squibb Company)的免疫疗法药物Opdivo (nivolumab,纳武利尤单抗,CAS登记号946414-94-4)与其他化疗药物联合用药用于晚期或转移性胃癌,胃食管结合部癌及食管腺癌的初始治疗.这是FDA首次批准免疫疗法药物用于胃癌一线治疗.夏训明编译广东药科大学学报...
2021年1月20日,FDA授予了纳武单抗(Nivolumab,Opdivo)的补充生物制剂许可申请优先审查资格,联合含氟嘧啶及含铂化疗,用于一线治疗晚期或转移性胃、食管及胃食管结合腺癌患者。 该审查基于Ⅲ期的CheckMate-649试验结果,该研究对比了纳武单抗+FOLFOX(亚叶酸+5-氟尿嘧啶+奥沙利铂)或CapeOX(卡培他滨+奥沙利铂)方案,以及...
昨日FDA加速批准nivo单药治疗先前接受过包括一轮是含铂化疗在内的2轮及以上治疗后进展的小细胞肺癌(所以这个应该是三线了吧,好忐忑 )。 The FDA has granted an accelerated approval to single-agent nivolumab (Opdivo) for the treatment of patients with small cell lung cancer (SCLC) with disease progressio...
which include, without limitation: the availability of data at the referenced times; complexities and the unpredictability of the regulatory review and approval processes in the U.S. and elsewhere; Exelixis’ and BMS’ continuing
(95% CI, 5.5 - 9.1) in the nivolumab group versus 5.1 months (95% CI, 4.0 - 6.0) in the standard therapy arm] while the estimates of the 1-year survival rate were approximately 19% higher with nivolumab than with standard therapy (36.0% vs. 16.6%). FDA approval was granted in ...
FDA Approval Summary: Nivolumab for the Treatment of Metastatic Non-Small Cell Lung Cancer With Progression On or After Platinum-Based Chemotherapy. : On October 9, 2015, the U.S. Food and Drug Administration expanded the nivolumab metastatic non-small cell lung cancer (NSCLC) indication to incl...
The FDA approval of Opdivo to treat esophageal cancer was based on data from a Phase 3 clinical trial (NCT02569242) called ATTRACTION-3. The study included 419 patients who randomly received either Opdivo or the standard chemotherapies Taxotere or Taxol. All treatments were given into the ...
At stake is the largest share of a PD-1 market projected to peak as high as $35 billion a year, and Bristol-Myers is contending with Merck ($MRK), AstraZeneca ($AZN), Roche ($RHHBY) and others with plans to string together FDA approvals and capitalize on stellar data for the whole...
Cancer Immunotherapy Update: FDA-Approved Checkpoint Inhibitors and Companion Diagnostics 2021, AAPS Journal View all citing articles on Scopus Presented at: These data were presented in part at the European Society for Medical Oncology Virtual Congress 2020, 19 to 21 September. Poster 711P. Contribu...
https://www.fda.gov/drugs/resources-information-approved-drugs/modification-dosage-regimen-nivolumab 16. Bajaj G, Wang X, Agrawal S, Gupta M, Roy A, Feng Y. Model-based population pharmacokinetic analysis of nivolumab in patients with solid tumors. CPT Pharmacometrics...