Erdafitinib is an orally administered drug in phase 2 and 3 clinical trials for the treatment of advanced refractory solid tumors, particularly in urothelial cancer. Erdafitinib is a potent, selective fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor. FGFRs are transmembrane proteins that regulate key processes including cell migration, proliferation, differentiation, and survival, particularly in embryonic development and during inflammation and wound healing. FGFRs are present in many types of cells including skin, mucosa, and bone, as well as tumor cells, and have been shown to play a critical role in tumor cell growth, survival, migration, and angiogenesis. Deregulation of FGFR pathways and FGFR-activating mutations have been associated with progression of human malignancies including breast, lung, prostate, endometrial, gastric, and urothelial carcinomas (3, 4). Erdafitinib has demonstrated target inhibition and pathway modulation in FGFR pathway activated cellular models of various cancers including lung, breast, gastric, bladder, and liver.
Affygility Solutions has an occupational exposure limit (OEL) and control band assignment for this active pharmaceutical ingredient (API). This monograph also contains the acceptable daily exposure (ADE) value.
OEL Fastrac monographs are a cost-effective and convenient way to meet the requirements for PDEs (ADEs) contained in the EMA Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (EMA/CHMP/CVMP/SWP/169430/2012), and to obtain the following information:
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Affygility Solutions’s OEL Fastrac service is an user-friendly system that enables us to make confident decisions and focus on moving the compound safely through our facility. We can quickly access the database to determine if a new drug is within the OEL Fastrac library, and if so, immediately download a detailed OEL banding report. The OEL Fastrac system has been a helpful tool in our overall EH&S program.