Bristol Myers Squibb revealed in a press release that the U.S. Food and Drug Administration (FDA) has sanctioned Augtyro™ (repotrectinib) for treating adult patients diagnosed with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).
Augtyro is a tyrosine kinase inhibitor (TKI) designed to target ROS1 oncogenic fusions. The FDA-approved Augtyro dosage is 160 mg orally once daily for 14 days, then twice daily.
The FDA approval stems from the TRIDENT-1 study, an open-label, Phase 1/2 trial that assessed Augtyro in TKI-naïve and TKI-pretreated patients. In TKI-naïve patients, the response rate was 79% with a 34.1-month duration; TKI-pretreated patients showed a 38% response rate lasting 14.8 months. Brain metastases responded well.
Dr. Jessica J. Lin, primary investigator of TRIDENT-1 and attending physician at Massachusetts General Hospital’s Center for Thoracic Cancers, as well as Assistant Professor of Medicine at Harvard Medical School, emphasized the ongoing necessity for fresh treatment approaches for individuals diagnosed with ROS1 fusion-positive NSCLC. These treatments should align with crucial clinical objectives, notably the attainment of long-lasting therapeutic responses.
Dr. Lin highlighted that, based on the TRIDENT-1 trial data, repotrectinib displays promise as a potential new standard of care for patients dealing with locally advanced or metastatic ROS1 fusion-positive lung cancer.
Janet Freeman-Daily, co-founder and president of The ROS1ders, highlighted the challenges faced by patients and families dealing with ROS1-positive NSCLC, particularly when the cancer spreads to the brain.
She noted that the FDA approval introduces a fresh treatment avenue for the ROS1-positive patient community, offering hope for extended quality time with their loved ones.
Source: U.S. Food and Drug Administration Approves Augtyro™ (repotrectinib), a Next-Generation Tyrosine Kinase Inhibitor (TKI), for the Treatment of Locally Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer (NSCLC).
https://news.bms.com/news/corporate-financial/2023/US-Food-and-Drug-Administration-Approves-Augtyro/default.aspx
