Loxo plans NDA for late-2017
- Loxo Oncology has updated the status of its pipeline, including its lead drug, the TRK inhibitor larotrectinib. Larotrectinib's ongoing trials are 85% enrolled, with efficacy studies expected to complete enrollment in early 2017. An NDA is planned for late 2017/early 2018 with a European MAA for 2018, based on data due out in the second half of 2017.
- Loxo's RET inhibitor LOXO-292 is expected to begin Phase 1 in early 2017; the drug will target MEN 2 syndrome, associated with medullary thyroid cancer and pheochromocytoma. Phase 1 trials are planned for the TRK inhibitor LOXO-195 in mid-2017.
- On the news, the share price ticked up to an increase as high as 31%, ending the day up 26%, to close at $33.86. While an incremental update, shareholders were pleased the company is on track.
Loxo Oncology has given the market an upbeat heads-up on its pipeline, including its lead drug, the TRK inhibitor larotrectinib. While the release doesn't provide much in the way of new data, it has updated timelines, and this has given the company's share price a boost.
Loxo's lead, larotrectinib, will be submitted for approval for the treatment of unresectable or metastatic solid tumors with NTRK-fusion proteins in adult and pediatric patients who require systemic therapy and who have either progressed following prior treatment or who have no acceptable alternative treatments. The FDA has also granted the drug rare pediatric disease designation for infantile fibrosarcoma. This designation will allow Loxo to apply to take part in the FDA’s Rare Pediatric Disease Priority Review Voucher Program.
"Since initiating our NAVIGATE Phase 2 trial in October 2015, we have been hard at work identifying TRK fusion patients and engaging with regulators to pursue a rapid path to market for larotrectinib," said Josh Bilenker, chief executive officer of Loxo Oncology.
"Based on current enrollment and written regulatory correspondence, we are able to… begin planning for a potential commercial launch. We look forward to sharing top-line data for the NDA dataset in concert with worldwide regulatory filings. We are also excited to bring LOXO-292 and LOXO-195 forward into potential proof-of-concept studies in 2017," he said.
- Loxo Oncology Statement
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