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U.S. FDA Greenlights Augtyro™ (Repotrectinib), an Advanced Tyrosine Kinase Inhibitor (TKI), for Locally Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer (NSCLC) Treatment

Thursday, November 16, 2023

Bristol Myers Squibb has received approval from the U.S. Food and Drug Administration (FDA) for Augtyro™ (repotrectinib), an oral tyrosine kinase inhibitor (TKI), to treat adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). The approval is based on the positive outcomes of the TRIDENT-1 study, a Phase 1/2 trial assessing Augtyro in both TKI-naïve and TKI-pretreated patients.

In TKI-naïve patients (n=71), Augtyro demonstrated a remarkable 79% objective response rate (ORR), with a median duration of response (mDOR) of 34.1 months. For TKI-pretreated patients (n=56), the ORR was 38%, and the mDOR was 14.8 months. Notably, responses in intracranial lesions were observed in patients with measurable central nervous system (CNS) metastases.

TRIDENT-1, highlighted the potential of Augtyro to become a new standard of care for ROS1-positive NSCLC, addressing the need for effective and lasting therapeutic responses. The drug is associated with specific warnings and precautions, including central nervous system effects, interstitial lung disease, hepatotoxicity, myalgia, hyperuricemia, skeletal fractures, and embryo-fetal toxicity.

Bristol Myers Squibb, emphasized the significance of Augtyro as the only approved next-generation TKI for ROS1-positive NSCLC patients. Janet Freeman-Daily, President of The ROS1ders, a patient advocacy organization, expressed hope for extended quality time with loved ones with this new treatment option.

Augtyro is designed to minimize treatment resistance in ROS1-positive metastatic NSCLC patients and is expected to be available in the U.S. by mid-December 2023. Bristol Myers Squibb expressed gratitude to the patients and investigators involved in the TRIDENT-1 clinical trial program.

The TRIDENT-1 trial, a global Phase 1/2 study, evaluated the safety, tolerability, pharmacokinetics, and anti-tumor activity of repotrectinib in advanced solid tumors, including NSCLC. The FDA-approved dosing for Augtyro is 160 mg orally once daily for 14 days, then increased to 160 mg twice daily until disease progression or unacceptable toxicity.

While Augtyro demonstrated positive outcomes, it is essential to note its safety profile. Serious adverse reactions occurred in 33% of patients, with pneumonia, dyspnea, pleural effusion, and hypoxia being notable events. Fatal adverse reactions occurred in 4.2% of patients, with dizziness, dysgeusia, peripheral neuropathy, and constipation being common adverse reactions.

Lung cancer, particularly NSCLC, remains a leading cause of cancer-related deaths in the U.S. ROS1 fusions, present in about 1-2% of NSCLC patients, tend to be aggressive and may spread to the brain. Augtyro's approval provides a new treatment option for ROS1-positive NSCLC, addressing an unmet need in this challenging-to-treat form of the disease.



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