The traditional regulatory drug approval paradigm comprising discrete phases of clinical testing that culminate in a large randomized superiority trial has historically been predominant in oncology. However, this approach has evolved in the current era o
The traditional regulatory drug approval paradigm comprising discrete phases of clinical testing that culminate in a large randomized superiority trial has historically been predominant in oncology. However, this approach has evolved in the current era of drug development, with multiple other development ...
Although data from this study has not yet been released, findings from this trial have also led to fast track and orphan drug designations from the FDA for avelumab. Findings from the phase II study are being prepared for presentation at an upcoming conference in 2016. See more at:http:/...
One of the first new approvals to emerge from the US Food and Drug Administration's (FDA's) new process for reviewing oncology drugs took only 2 weeks from submission of the supplemental application to approval for the new indication. The approval was for expanded use of brentuximab vedotin (...
“New drugs” are defined as new chemical drugs, new biological products, gene and cell therapies, new vaccines, and new traditional Chinese medicines approved for the first time in mainland China. Chemical drugs accounted for the largest proportion of new drug approvals (72, or 69.2%), ...
these compounds, or may choose to approve compounds not approved by the FDA. Our focus on drug approvals by the FDA does not imply any opinion on the scientific quality of approvals by the FDA as compared to the regulatory authorities in other jurisdictions, but rather uses the FDA as a ...
An analysis of FDA-approved drugs for oncology Cancer remains the second leading cause of death globally. The number of new medicines targeting cancer has grown impressively since the 1990s. On average,... Kinch,S Michael - 《Drug Discovery Today》 被引量: 146发表: 2014年 New drugs—reports...
A De Bernardi,T Bachelot,L Larrouquère - 《Frontiers in Oncology》 被引量: 0发表: 2024年 CNS efficacy of trastuzumab deruxtecan in metastatic breast cancer: A single-institution, real-world analysis. e13117#Background:Trastuzumab deruxtecan (T-DXd) is an antibody-drug conjugate that revolu...
Koopman, M., et al. Deficient mismatch repair system in patients with sporadic advanced colorectal cancer. Br J Cancer. 209;100(2), 266–273. doi:10.1038/sj.bjc.6604867. Ahcene Djaballah S, et al. HER2 in Colorectal Cancer: The Long and Winding Road ...
Immune checkpoints are important regulatory pathways in the immune system that are triggered by ligand-receptor interactions. Besides, they have a crucial role in the development of an effective immune response to eliminate infectious particles and tumor cells but no response against the self-antigens...