FDA Accepts Larotrectinib New Drug Application and Grants Priority Review
The U.S. Food and Drug Administration (FDA) has accepted a new drug application (NDA) and granted Priority Review for larotrectinib in the treatment of adult and pediatric patients with locally advanced or metastatic solid tumors harboring a neurotrophic receptor tyrosine kinase (NTRK) gene fusion. The FDA has set a target action date of November 26, 2018, under the Prescription Drug User Fee Act (PDUFA).
“We are excited the larotrectinib NDA has been accepted by the FDA and granted Priority Review status,” said Josh Bilenker, MD, Chief Executive Officer of Loxo Oncology. “Larotrectinib marks an important shift toward treating cancer based on the tumor’s genetics rather than its site of origin in the body.”
The FDA grants Priority Review for the applications of medicines that, if approved, would provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications. Larotrectinib has also been granted Breakthrough Therapy designation, Rare Pediatric Disease designation, and Orphan Drug designation by the FDA.
About Larotrectinib
Formerly known as LOXO-101, Larotrectinib is an oral and highly selective investigational tropomyosin receptor kinase inhibitor in clinical development for the treatment of patients with cancers that harbor an NTRK gene fusion. Growing research suggests that the NTRK genes, which encode for tropomyosin receptor kinases, can become abnormally fused to other genes, resulting in growth signals that can lead to cancer in many sites of the body.
In clinical trials, larotrectinib demonstrated antitumor activity in patients with tumors harboring NTRK gene fusions, regardless of patient age or tumor type. In an analysis of 55 adult and pediatric patients with NTRK gene fusions evaluable by Response Evaluation Criteria in Solid Tumors, larotrectinib demonstrated a 75% centrally assessed confirmed overall response rate and an 80% investigator-assessed confirmed overall response rate, across many different types of solid tumors. The majority of all adverse events were grade 1 or 2.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
