The FDA approved FoundationOne CDx as a companion diagnostic for alpelisib in combination with fulvestrant to treat certain PIK3CA-mutated breast cancers.
At least one drugmaker is planning to submit for FDA approval of its KRAS inhibitor based on data from Phase I/II, single-arm trial in heavily pretreated lung cancer patients.
Recent studies question the clinical utility of tumor mutational burden as a biomarker for immuno-oncology response, and the FDA clearance includes no therapeutic indications.
For heavily pretreated ovarian cancer patients, doctors will now have to weigh their HRD status in the context of an increasingly complex backdrop of biomarker information.
The drug is now approved as a fourth-line option for advanced, fallopian tube, or primary peritoneal cancer patients who have homologous recombination deficiency.
Diaceutics is projecting that FDA will soon approve more personalized drugs than all-comer drugs, but absent changes in diagnostics strategies many patients won't receive them.
