Breakthrough in Lung Cancer Treatment: FDA Approves Augtyro

In a significant stride towards combating non-small cell lung cancer (NSCLC), the U.S. Food and Drug Administration (FDA) granted approval to Augtyro (repotrectinib) on November 15, 2023. This next-generation Tyrosine Kinase Inhibitor (TKI) is a beacon of hope for adult patients grappling with locally advanced or metastatic ROS1-positive NSCLC. Let’s delve into the groundbreaking features of Augtyro and its potential impact on cancer treatment.

Understanding ROS1-Positive NSCLC and Augtyro’s Mechanism:

ROS1-positive NSCLC is characterized by the fusion of the ROS1 gene with another gene, resulting in uncontrolled cell growth and cancer. Augtyro, a potent TKI, works by inhibiting the ROS1 gene and receptor tyrosine kinases. This dual action helps regulate cancer growth and reduce tumor size, offering a targeted and effective approach to treatment.

Clinical Efficacy:

The FDA approval of Augtyro was based on promising results from the Phase 1/2 trial, particularly in patients who had not previously undergone TKI treatment. Key findings include:

  • 79% of patients experienced a partial response with a reduction in tumor size.
  • 6% of patients achieved a complete response, indicating the absence of cancer signs.
  • The median duration of response (mDOR) was an impressive 34.1 months.
  • Notably, 7 out of 8 patients with brain tumors showed a positive response.
  • Augtyro’s unique design as a next-generation TKI aims to enhance its efficacy against brain tumors, potentially extending the duration before resistance to treatment occurs.

Side Effects and Safety Considerations:

While Augtyro shows promise in treating ROS1-positive NSCLC, it’s essential to be aware of potential side effects. Common side effects include dizziness, changes in taste, numbness or tingling, constipation, nausea, and fatigue. However, some serious side effects may occur, such as central nervous system (CNS) effects, lung problems (pneumonitis), liver problems, muscle problems, increased uric acid levels, and an increased risk of bone fractures.

Before initiating Augtyro treatment, patients are advised to inform their healthcare provider about pre-existing conditions, including nervous system problems, lung issues, and liver problems.

Dosage and Administration:

Augtyro is administered in capsule form, with a recommended dosage of 160 mg taken once daily for the first 14 days, followed by an increase to 160 mg twice daily. The treatment continues until disease progression or unacceptable toxicity levels are reached.

Patients are instructed not to crush, chew, or dissolve the capsules, and any missed doses should not be compensated with double doses. Additionally, caution is advised regarding grapefruit consumption during treatment, as it may elevate Augtyro levels in the blood to harmful extents.

Interaction with Other Medications:

Augtyro may interact with certain medications, affecting their efficacy or increasing side effects. Patients are advised to disclose their current medications, especially contraceptives, strong or moderate CYP3A inhibitors, P-gp inhibitors, strong or moderate CYP3A inducers, and certain CYP3A4 substrates.

Pregnancy and Breastfeeding Considerations:

Augtyro poses risks to unborn babies, and pregnant individuals should undergo a pregnancy test before starting treatment. Effective non-hormonal birth control methods are recommended during treatment and for a specified duration after the last dose. Breastfeeding is not advisable during Augtyro treatment, and alternative feeding methods should be discussed with healthcare providers.


Augtyro’s FDA approval marks a significant advancement in the treatment landscape for ROS1-positive NSCLC. As with any medical intervention, patients and healthcare providers must weigh the benefits against potential risks, considering individual health conditions and medical history. Augtyro’s innovative approach offers hope for improved outcomes in the fight against lung cancer, ushering in a new era of targeted and effective therapies.

Please note that this blog post is a general overview and should not replace professional medical advice. Patients are encouraged to consult with their healthcare providers for personalized guidance based on their specific circumstances.