[17]Lemery S, Keegan P, Pazdur R. First FDA Approval Agnostic of Cancer Site - When a Biomarker Defines the Indication. N Engl J Med. 2017 Oct 12;377(15):1409-1412. doi: 10.1056/NEJMp1709968. PMID: 29020592. [18]Chung H C,Ros W, Delord J P, et al. Efficacyand safety of pe...
Thomas E. Stinchcombe, MD, professor of medicine, Duke Cancer Institute, discusses the KEYNOTE-189 trial in patients with lung cancer. The KEYNOTE-189 trial builds upon cohort G of the KEYNOTE-21 trial, which was a phase II trial that randomized patients to carboplatin/pemetrexed alone or c...
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 c...
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 ...
KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be...
KEYNOTE: Creating Nanostructured Coatings to Improve Medical Device Performance while Obtaining Fast FDA ApprovalWebster, Thomas J
KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumo...
FDA Approval Summary: Atezolizumab or Pembrolizumab for the Treatment of Patients with Advanced Urot... Pre-pembrolizumab neutrophil-to-lymphocyte ratio (NLR) predicts the efficacy of second-line pembroli... Profile of pembrolizumab in the treatment of patients with unresectable or metastatic urothelial...
后续启动Ph3 KEYNOTE-811,主要终点PFS和OS https:///ct2/show/NCT03615326 Data Supporting the Approval The approval was based on data from KEYNOTE-811 (ClinicalTrials.gov, NCT03615326), a multicenter, randomized, double-blind, placebo-controlled trial that was designed to enroll 692 patients with...
[17]Lemery S, Keegan P, Pazdur R. First FDA Approval Agnostic of Cancer Site - When a Biomarker Defines the Indication. N Engl J Med. 2017 Oct 12;377(15):1409-1412. doi: 10.1056/NEJMp1709968. PMID: 29020592. [18]Chung H C,Ros W, Delord J P, et al. Efficacyand safety of pe...