BMS’s Augtyro approved by FDA for lung cancer treatment

Bristol Myers Squibb has announced that the US Food and Drug Administration (FDA) has approved Augtyro (repotrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).
The drug is administered as an oral therapy and is a tyrosine kinase inhibitor (TKI) targeting ROS1 oncogenic fusions.
The approval is based on results from the TRIDENT-1 study, an open-label, single-arm, phase 1/2 trial that aimed to assess the drug in TKI-naïve and TKI-pretreated patients.
The drug has several warnings and precautions surrounding central nervous system (CNS) effects, interstitial lung disease (ILD)/pneumonitis, hepatotoxicity, myalgia with creatine phosphokinase elevation, hyperuricaemia, skeletal fractures and embryo-foetal toxicity.
Samit Hirawat MD, executive vice president, chief medical officer, Global Drug Development at Bristol Myers Squibb, commented: “While progress has been made in the treatment of NSCLC over the past decade, there is still a need to address this particularly difficult-to-treat form of the disease with innovative science and a targeted approach. As the only approved next-generation TKI for ROS1-positive NSCLC patients, Augtyro builds on our legacy of delivering transformational therapies for patients with thoracic cancers.”
Janet Freeman-Daily, co-founder and president of The ROS1ders, a patient advocacy organisation, added: “ROS1-positive NSCLC patients and their families face a stressful journey because our cancer can be difficult to treat, especially when it spreads to the brain. Today’s approval brings a new treatment option for the ROS1-positive patient community, which gives us hope for more time with loved ones.”
Jessica J Lin MD, TRIDENT-1 primary investigator and attending physician at the Center for Thoracic Cancers at Massachusetts General Hospital and assistant professor of Medicine at Harvard Medical School, both US, stated: “New treatment options continue to be needed for patients with ROS1 fusion-positive NSCLC that support important clinical goals, including achieving durable therapeutic responses. Based on the data we have seen in the TRIDENT-1 trial, repotrectinib has the potential to become a new standard-of-care option for patients with locally advanced or metastatic ROS1 fusion-positive lung cancer.”