Pharmacogenetic Data Integration Into Labeling To Be Discussed By Subcommittee
This article was originally published in The Pink Sheet Daily
Clinical Pharmacology Subcommittee will meet Nov. 14-15 on several topics including pharmacogenetic data integration and the biomarker-surrogate endpoint project of FDA's "Critical Path" initiative.
You may also be interested in...
Patients with the deficiency of a metabolizing enzyme have an increased risk of neutropenia, revised labeling for Pfizer’s oncologic says. Patients with the deficiency should start at a lower dose, though the appropriate starting dose is not known, FDA says.
Irinotecan will be used as an example of pharmacogenetic toxicity risk at Clinical Pharmacology Subcommittee meeting Nov. 3-4. Pfizer is discussing label changes with FDA regarding Camptosar use in patients with certain genotypes. Subcommittee will also address the transition of biomarkers to surrogate endpoints.
The Irvine, Calif., firm also plans sNDAs for a colorectal cancer claim and an oral formulation of the leucovorin relative.