不限瘤种 2017年05月23日,帕博利珠单抗获FDA批准用于MSI-H/dMMR(微卫星不稳定性高)的不限癌种适应症。帕博利珠单抗是FDA批准的第一个不按肿瘤来源,按生物标志物进行区分的抗肿瘤疗法,成为真正的“广谱抗癌药”,在肿瘤治疗中具有划时代的意义。 PD-1和PD-L1的信号机制以及高微卫星不稳定癌症中PD-1信号的抑制...
In the phase III KEYNOTE-189 study (NCT02578680), pembrolizumab plus pemetrexed and platinum-based chemotherapy (pemetrexed–platinum) significantly improved overall survival (OS) and progression-free survival (PFS) in patients with previously untreated metastatic nonsquamous non-small-cell lung cancer ...
There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially ...
Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. Renal Cell Carcinoma KEYTRUDA, in combination with axitinib, is indicated for the first-line treat...
Mark A. Socinski, MD:From the analysis of KEYNOTE-024 and -189, the 1-year survival is about the same, but the response rate was about 20% higher with the addition of chemotherapy. For those symptomatic patients, that’s my strategy....
KEYNOTE: Creating Nanostructured Coatings to Improve Medical Device Performance while Obtaining Fast FDA ApprovalWebster, Thomas J
Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. Renal Cell Carcinoma KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC)...
6.KEYNOTE-189(非鳞):III期,K药+化疗 VS 化疗,一线,生存获益。 7.KEYNOTE-407(鳞):III期,K药+化疗 VS 化疗,一线,生存获益。 联合免疫探索 8.KEYNOTE-598:K药+Y药 vs K药,一线,双免没有任何获益。 围术期免疫治疗 9.KEYNOTE-671研究:III期,K药+化疗→手术→K药维持 vs 化疗→手术,EFS获益;确立治...
This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. Esophageal Cancer KEYTRUDA is indicated for the treatm...
Adverse reactions observed in KEYNOTE-407 were similar to those observed in KEYNOTE-189 with the exception that increased incidences of alopecia (47% vs 36%) and peripheral neuropathy (31% vs 25%) were observed in the KEYTRUDA and ...