FDA Grants Larotrectinib New Drug Application and Priority Review for Solid Tumors

This morning, the US Food and Drug Administration accepted Loxo Oncology, Inc’s New Drug Application (NDA) and granted Priority Review to the company’s drug, larotrectinib, for the treatment of locally advanced or metastatic solid tumors containing an NTRK gene fusion on both adult and pediatric patients.

“We are excited the larotrectinib NDA has been accepted by FDA and granted Priority Review status,” commented Josh Bilenker, MD, chief executive officer of Loxo Oncology in a recent statement. “Larotrectinib marks an important shift towards treating cancer based on the tumor’s genetics rather than its site of origin in the body.”

Larotrectinib, which is an inhibitor in clinical development for the treatment of patients with cancers that harbor a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, is an oral and highly selective investigational tropomyosin receptor kinase (TRK).

In the phase 2 clinical trial, the current primary outcome measure is the Overall Response Rate of confirmed complete responses (CR) or partial responses (PR) as decided by an Independent Radiology Committee using RECIST 1.1 (Response Evaluation Criteria in Solid Tumors; assess solid tumor responses in patients in clinical trials) or RANO criteria (The Response Assessment in Neuro-Oncology Brain Metastases; measures brain metastases progression) in a time frame of up to 30 months.

The global, multicenter, single-arm, open-label, phase 2 basket trial will assess 8 patient cohorts with tumors containing NTRK1, NTRK2, or NTRK3 fusions, including non—small cell lung cancer, thyroid cancer, sarcoma, colorectal cancer, salivary gland cancer, biliary cancer, and primary central nervous system (CNS) tumor in addition to a cohort that will enroll patients not included in the histologies previously listed.

Collaboratively, Loxo Oncology and Bayer are developing larotrectinib for commercialization. In 2018, Bayer plans to submit a Marketing Authorization Application (MAA) in the European Union.

Currently, the set target action date is planned for November 26, 2018, under the Prescription Drug User Fee Act (PDUFA).

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