Savolitinib, also referred to as AZD6094 and HMPL-504, has been used in trials studying the treatment and health services research of tumors, food effects, gastric cancer, and colorectal cancer, among others. Savolitinib has been demonstrated to inhibit the growth of tumors in a series of preclinical disease models, selectively for those tumors with aberrant c-Met signaling. It has shown favorable pharmacokinetic properties in late stage cancer patients, and has shown encouraging anti-tumor activity in several tumor-types, particularly for metastatic papillary renal cell cancer (PRCC). Savolitinib is an orally bioavailable inhibitor of the c-Met receptor tyrosine kinase (IC 50 3 – 5 nM) with potential antineoplastic activity. It selectively binds to and inhibits the activation of c-Met in an ATP-competitive manner, which disrupts c-Met signal transduction pathways. This may result in cell growth inhibition in tumors that overexpress the c-Met protein. The ligand for c-Met is hepatocyte growth factor (HGF), which activates a wide range of cellular signaling pathways, including those involved in proliferation, invasion, metastasis and tumor angiogenesis. C-Met has been found to be highly activated in a number of human cancers.
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.