
FDA accepts Loxo approval application for biomarker-driven cancer drug
If approved, LOXO-101 (larotrectinib) would be the second drug to win a biomarker-based label, after Merck's Keytruda.
If approved, LOXO-101 (larotrectinib) would be the second drug to win a biomarker-based label, after Merck's Keytruda.
A new report shows a steady growth in so-called "basket studies" in oncology, along with growing interest by the drug industry.
Loxo's data highlight growing industry interest in so-called "basket" trials and drugs that targeted to genetic markers instead of tumor types.
Ignyta's lead molecule, entrectinib, is currently in Phase 2 clinical trials targeting rare mutations in non small cell lung cancer and solid tumors.