Loxo Oncology Completes Rolling Submission of New Drug Application to U.S. Food and Drug Administration

Loxo Oncology (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, today announced that the company has completed the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for larotrectinib for the treatment of adult and pediatric patients with locally advanced or metastatic solid tumors harboring an NTRK gene fusion.

As quoted in the press release.

“We are grateful to the many patients who participated in our clinical trials in the spirit of helping others with advanced cancer,” said Josh Bilenker, M.D., chief executive officer of Loxo Oncology. “We hope that the larotrectinib development program inspires others to develop drugs for both adult and pediatric patients on the basis of tumor genetics rather than tumor site of origin.”

Click here to read the full press release.