The U.S. Food and Drug Administration (FDA) approves Augtyro (repotrectinib), a next-generation tyrosine kinase inhibitor (TKI), for the treatment of patients with locally advanced or metastatic NTRK-positive solid tumors.

Augtyro is the only FDA-approved treatment option for NTRK-positive tumors studied in TKI-naive and TKI-pretreated patients in solid tumors, demonstrating clinically meaningful response rates in the TRIDENT-1 trial.

Augtyro's safety profile was evaluated in 426 patients who received Augtyro in the pivotal TRIDENT-1 trial.

' NTRK fusion-positive tumors can present challenges in the clinical setting, which is why it's important that we have additional treatment options for these patients,' said Alexander Drilon, MD, leader of the global TRIDENT-1 trial and head of early drug development at Memorial Sloan Kettering Cancer Center.

' The FDA's approval of repotrectinib adds an important tool to our toolbox, offering oncologists a next-generation TKI that can be used on a wide range of NTRK fusion-positive solid tumors for TKI-naive and TKI-pretreated patients. '

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