News on companion diagnostics and drug/test co-development.
The CDx, which will include the detection of activating FGFR2 fusions, is expected to be incorporated into Foundation Medicine's FDA-approved FoundationOne CDx assay.
Qiagen and Foundation Medicine will develop tissue- and plasma-based companion tests to identify best responders to the PI3K inhibitor alpelisib
The guidance addresses cases in which there's enough evidence to conclude that the CDx is suitable for use with a specific group or class of oncology therapies.
The CDx would guide use of Novartis' BYL719 (alpelisib) in combination with fulvestrant for men and postmenopausal women with HR+/HER2- breast cancer.
New data on Kadcyla and Tecentriq will help doctors further refine precision medicine options for breast cancer patients with unmet needs.
