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Troy Kish, Lauren Corry
No abstract text is available yet for this article.
May 2016: P & T: a Peer-reviewed Journal for Formulary Management
(no author information available yet)
No abstract text is available yet for this article.
February 29, 2016: Medical Letter on Drugs and Therapeutics
Varun Goel, Eunju Hurh, Andrew Stein, Jerry Nedelman, Jocelyn Zhou, Ovidiu Chiparus, Pai-Hsi Huang, Sven Gogov, Dalila Sellami
PURPOSE: Sonidegib (Odomzo) selectively inhibits smoothened and suppresses the growth of hedgehog pathway-dependent tumors. A population pharmacokinetic (PK) analysis of sonidegib in healthy subjects and patients with advanced solid tumors was conducted to characterize PK, determine variability, and estimate covariate effects. METHODS: PK data from five phase 1 or 2 studies (N = 436) in the dose range from 100 to 3000 mg were analyzed using NONMEM. A two-compartment base model with first-order absorption, lag time, linear elimination, and bioavailability that decreased with dose was updated to describe the PK of sonidegib...
April 2016: Cancer Chemotherapy and Pharmacology
Celeste B Burness, Lesley J Scott
Sonidegib (Odomzo®), an oral smoothened (SMO) antagonist, is indicated for the treatment of adults with locally advanced basal cell carcinoma (laBCC) who are not candidates for surgery or radiation therapy, or adults with recurrent laBCC following surgery or radiation therapy. In the multicentre BOLT trial, the primary endpoint (i.e., an objective tumour response rate point estimate of ≥30 % and a 95 % confidence interval lower bound of >20 % in patients with fully assessable laBCC and all patients with metastatic BCC) was met at the primary analysis cut-off date (median follow-up 13...
April 2016: Targeted Oncology
Celeste B Burness
Sonidegib (Odomzo™) is an orally bioavailable, small molecule, Smoothened (SMO) receptor antagonist that is being developed by Novartis for the treatment of cancer. SMO is a G protein-coupled receptor-like molecule that is essential for the actions of the Hedgehog family of secreted proteins, which play a critical role in the development and homeostasis of many organs and tissues. Oral sonidegib is approved in Switzerland for the treatment of adult patients with advanced basal cell carcinoma (BCC) and in the US and EU for the treatment of adult patients with locally advanced BCC that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy...
September 2015: Drugs
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