- Loxo Oncology (NASDAQ:LOXO) initiates the rolling submission of its U.S. marketing application seeking approval for larotrectinib (LOXO-101) for the treatment of adult and pediatric patients with unresectable/metastatic solid tumors with NTRK-fusion proteins who require systemic therapy and have progressed after prior treatment or who have no viable alternative treatment options.
- It has Orphan Drug, Breakthrough Therapy and Rare Pediatric Disease Designation status in the U.S.
- Larotrectinib inhibits a group of enzymes called tropomyosin receptor kinases (TRK), a group of proteins that plays a key role in cellular communications. Cancers hijack these communication pathways to send messages to cells to grow, change or survive. Those characterized by these alterations, termed NTRK fusions, are the therapeutic targets for the drug.
- Previously: Loxo's larotrectinib shows significant treatment benefit in early-stage pediatric cancer study; shares ahead 2% (Dec. 4)
- Now read: 3 Things In Biotech You Should Learn Today: December 5, 2017
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