“To have achieved overall survival from this landmark study is highly encouraging and builds upon the positive pathological complete response and event-free survival results that led to approvals for this regimen around the world.” KEY...
The PATHWAY HER2 (4B5) test is now FDA-approved to assess HER2-ultralow status in metastatic breast cancer, expanding its prior HER2-low indication. Read More Behind the FDA Approval of Dato-DXd in HR+/HER2– Breast Cancer With Bardia Jordyn Sava;Aditya Bardia, MD, MPH February 7th 2025...
KEYNOTE-522:无论PD-L1表达状态如何,与化疗(n=201)相比, Keytruda+化疗(n=401)在pCR方面表现出统计学意义的显著增加(pCR:64.8% vs 51.2%,p=0.00055)。在另一个主要终点EFS方面,中位随访15.5个月,与化疗-安慰剂方案相比,Keytruda方案在EFS方面表现出有利趋势、将新辅助期疾病进展和辅助期复发的风险降低了37%...
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 ...
HRQoL with neoadjuvant pembrolizumab + chemotherapy vs placebo + chemotherapy, followed by adjuvant pembrolizumab vs placebo for early-stage TNBC: results from KEYNOTE-522. Presented at: ESMO Congress 2022; September 9-13, 2022; Paris, France. Abstract 135MO....
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)...
KEYNOTE: Creating Nanostructured Coatings to Improve Medical Device Performance while Obtaining Fast FDA ApprovalWebster, Thomas J
These findings were crucial in securing FDA approval for pembrolizumab’s use in patients with BCG-unresponsive NMIBC, making it a new therapeutic option for patients with limited treatment alternatives, Li notes. The rationale for conducting a post hoc analysis of KEYNOTE-057 st...
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...
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...