Regulatory Affairs

FDA grants priority review to Loxo's larotrectinib for several solid tumors

PBR Staff Writer Published 30 May 2018

The US Food and Drug Administration (FDA) has accepted Loxo Oncology’s new drug application (NDA) and granted priority review for larotrectinib to treat adult and pediatric patients with locally advanced or metastatic solid tumors harboring an neurotrophic tyrosine receptor kinase (NTRK) gene fusion.

Larotrectinib is an oral and highly selective investigational tropomyosin receptor kinase (TRK) inhibitor, which is currently under clinical development to treat patients with cancers that harbor a NTRK gene fusion.

TRK fusion cancer happens when a NTRK gene fuses with another unrelated gene, producing an altered tropomyosin receptor kinase (TRK) protein.

Loxo Oncology CEO Josh Bilenker said: “We are excited the larotrectinib NDA has been accepted by FDA and granted Priority Review status.

“Larotrectinib marks an important shift towards treating cancer based on the tumor’s genetics rather than its site of origin in the body.”

The company already secured breakthrough therapy status, rare pediatric disease designation and orphan drug designation from FDA for larotrectinib.

According to the company, larotrectinib showed anti-tumor activity in patients with tumors harboring NTRK gene fusions, regardless of patient age or tumor type, in clinical trials.

Larotrectinib demonstrated a 75% centrally-assessed confirmed overall response rate (ORR) and 80% investigator-assessed confirmed ORR in an analysis of 55 RECIST-evaluable adult and pediatric patients with NTRK gene fusions.

In November 2017, Loxo Oncology collaborated with Bayer for the development and commercialization of larotrectinib and LOXO-195, next-generation TRK inhibitor.

Bayer is planning to file a marketing authorization application for larotrectinib in the European Union in 2018.

The partnership will jointly develop the two products, while Loxo Oncology is responsible for ongoing clinical studies and filing in the US and Bayer is responsible for ex-US regulatory activities and worldwide commercial activities.

Loxo Oncology and Bayer will co-promote the products in the US.

Loxo Oncology is engaged in the development of selective medicines for patients with genetically defined cancers.