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FDA Sets Goal Date for Augtyro for Solid Tumors with NTRK Gene Fusions


Regulators have a set a date of June 15, 2024, to review new indication for Augtyro, which is already available to treat lung cancer with ROS1-positive lung and has a list price of $29,000 for a 30-day supply.

The FDA has accepted for priority review Bristol Myers Squibb’s supplemental new drug application for Augtyro (repotrectinib) and assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 15, 2024. Augtyro is being reviewed as a treatment for adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. If approved, it would be indicated for patients whose cancer is locally advanced or metastatic.

NTRK gene fusions can play a role in the development of cancer. They are rare in patients with solid tumors with less than 1% of patients testing positive, though may be more frequent in patients with other cancers.

Augtyro is an oral tyrosine kinase inhibitor (TKI) that is designed to target ROS1-positive or NTRK-positive locally advanced or metastatic solid tumors, including non-small cell lung cancer. It was developed by Turning Point Therapeutic, which Bristol Myers Squibb acquired in 2022.

Related: New Lung Cancer Drug Augtyro is Now Available

In November 2023, the FDA approved Augtyro to treat adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer NSCLC. The wholesale acquisition cost (WAC) for an adult is $29,000 based on 30-day supply of 160 mg twice a day.

The supplemental filing is based on data from the TRIDENT-1 and CARE trials. In the TRIDENT-1 phase 1/2 study, Augtyro was studied in patients with advanced solid tumors, including non-small cell lung cancer and included patients with ROS1 or NTRK fusions.

Augtyro demonstrated clinically meaningful response rates in patients with NTRK-positive locally advanced or metastatic solid tumors. Durability of response was robust, including among patients whose tumors harbor common resistance mutations, and intracranial responses were observed. Augtyro showed a safety profile that was well tolerated and generally manageable.

The CARE phase 1/2 open-label study evaluated Augtyro in pediatric and young adult patients with locally advanced or metastatic solid tumors harboring ALK, ROS1 or NTRK1-3 gene alterations.

Augtyro is also under review in the Europe Union for patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer and patients with NTRK-positive solid tumors.

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