Approvals

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.”