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Non-Small-Cell Lung Cancer (NSCLC)

Taletrectinib Received FDA Approval for ROS1-Positive NSCLC

Posted on June 23, 2025
Post Views: 1

Non-Small-Cell Lung Cancer (NSCLC)Recently, FDA has granted approval to Taletrectinib for treatment of locally advanced or metastatic ROS1-positive non-small cell lung cancer in adults. Taletrectinib has demonstrated high response rates and was well tolerated among patients. This approval is a meaningful step for advanced ROS1+ lung cancer community and provides hope for patients facing the challenge of cancer spreading to the brain.

ROS1+ NSCLC is a rare form of lung cancer and it accounts for about 2% of new NSCLC cases in the United States. The median age at diagnosis for patients is 50 years and it is more likely to occur for those who do not have history of smoking. Taletrectinib is an oral and central nervous system (CNS) approved for treatment of adults with advanced ROS1+ NSCLC. It is approved as a 600-mg once-daily oral dose and is supported by half-life of about 66 hours. Also, Taletrectinib was granted priority review, and orphan drug designation for this indication.

In this study, the clinical trials enrolled 157 patients who were naive to treatment with ROS1 tyrosine kinase inhibitor and 113 patients who had previously received at least one ROS1 TKI. TRUST-I findings showed that Taletrectinib Received a cORR of about 90% in patients who were TKI-naive. TRUST-II had affirmed this finding with a cORR of about 85%. The most common complications in patients with advances ROS1+ NSCLC patients is brain metastasis. In these trials, Taletrectinib demonstrated consistent intracranial responses in patients. In these trials, it delivered high response rates with sustained durability. As it has clinically proven efficacy and safety profile, Taletrectinib has the potential to become a new standard in this type of lung cancer.

The information shared in this blog is for educational purposes only. You should always consult with your healthcare provider for any medical needs.

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