Augtyro Gets FDA Priority Review for NTRK-Positive Solid Cancers

The FDA granted a priority review for Augtyro in patients with solid tumors.

The Food and Drug Administration (FDA) granted Augtyro (repotrectinib) a priority review for a supplemental New Drug Application for the treatment of patients aged 12 years and older with locally advanced or metastatic solid cancers that have an NTRK gene fusion that may not be good candidates for surgical resection, according to Bristol Myers Squibb, the pharmaceutical company behind the drug.

According to the FDA, drug sponsors can submit a supplemental New Drug Application for drugs that are already approved in another indication. The application — which must contain information on the drug’s safety and effectiveness — is asking the agency for permission to introduce the drug into the market for a new patient population. This particular case involves solid cancers with NTRK gene fusions.

After receiving the application, the FDA granted it a priority review, meaning that it will expedite the review and potential of the therapy since it potentially serves an unmet need for serious conditions. The agency plans on making its approval decision on or by June 15, 2024.

“While great advancements have been made over the last decade, patients with NTRK-positive locally advanced or metastatic solid tumors still experience significant unmet needs. New and effective treatment options that may improve durability of response and address resistance to existing tyrosine kinase inhibitors (TKIs) are critical to helping patients with these aggressive tumors,” Joseph Fiore, vice president, global program lead, Augtyro at Bristol Myers Squibb, said in a company-issued press release.

Augtyro is a TKI that works by targeting and blocking the NTRK or ROS1 genes, which can play a role in the development and proliferation of cancer.

READ MORE: Augtyro ‘Fills a Gap’ in the Treatment of ROS1-Positive NSCLC

The pharmaceutical company included data from two clinical trials in their filing of the supplemental new drug application: TRIDENT-1 and CARE — the former evaluated Augtyro in adults with NTRK-positive solid cancers, while the latter tested the drug in pediatric patients with the same disease subtype.

TRIDENT-1 — which led to the November 2023 approval of Augtyro for advanced ROS1-positive non-small cell lung cancer — is a phase 1/2 trial evaluating the safety, tolerability, pharmacokinetics, anti-tumor activity, response rate and progression-free survival for Augtyro in patients with locally advanced or metastatic solid tumors that have ROS1 or NTRK fusions.

CARE is a phase 1/2 trial evaluating the drug in pediatric patients with ALK, ROS1 or NTRK1-3 gene alterations. The first part of the study will evaluate safety and tolerability of Augtyro, while the second part will determine the efficacy and anti-tumor activity. For this part of the study, the main endpoints include overall response rate (percentage of patients whose cancer shrinks or disappears from treatment), time to response, duration of response, progression-free survival (time from treatment until death or disease worsening), central nervous system progression-free survival and overall survival (time from treatment until death of any cause).

“We look forward to working closely with the FDA on the review of our application for Augtyro for this tumor-agnostic indication and potentially offering patients with NTRK-positive disease a new, durable treatment option,” Fiore said.
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