FDA News

FDA grants priority review to larotrectinib for certain solid tumors

The FDA granted priority review designation to larotrectinib for the treatment of adult and pediatric patients with locally advanced or metastatic solid tumors harboring an NTRK gene fusion.

Larotrectinib (LOXO-101, Loxo Oncology) is a tropomyosin receptor kinase (TRK) inhibitor.

The FDA based the priority review designation on data from 55 adult and pediatric patients with NTRK gene fusions. When NTRK genes, which encode for TRKs, become abnormally fused to other genes, it may lead to growth signals that cause metastatic cancer.

Patients treated with larotrectinib demonstrated a 75% overall response rate, according to an independent central assessment. In the investigator assessment, larotrectinib conferred an 80% ORR.

The majority of adverse events were grade 1 or grade 2.

“We are excited the larotrectinib new drug application has been accepted by FDA and granted priority review status,” Josh Bilenker, MD, CEO of Loxo Oncology, said in a press release. “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 granted priority review designation to larotrectinib for the treatment of adult and pediatric patients with locally advanced or metastatic solid tumors harboring an NTRK gene fusion.

Larotrectinib (LOXO-101, Loxo Oncology) is a tropomyosin receptor kinase (TRK) inhibitor.

The FDA based the priority review designation on data from 55 adult and pediatric patients with NTRK gene fusions. When NTRK genes, which encode for TRKs, become abnormally fused to other genes, it may lead to growth signals that cause metastatic cancer.

Patients treated with larotrectinib demonstrated a 75% overall response rate, according to an independent central assessment. In the investigator assessment, larotrectinib conferred an 80% ORR.

The majority of adverse events were grade 1 or grade 2.

“We are excited the larotrectinib new drug application has been accepted by FDA and granted priority review status,” Josh Bilenker, MD, CEO of Loxo Oncology, said in a press release. “Larotrectinib marks an important shift toward treating cancer based on the tumor’s genetics rather than its site of origin in the body.”