Bristol Myers Squibb's lung cancer drug Augtyro receives FDA approval

Bristol Myers Squibb's (BMS) Augtyro (repotrectinib) has been approved by the US Food and Drug Administration (FDA) to treat adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).

Lung cancer is the leading cause of cancer deaths in the US, with NSCLC representing up to 85% of all lung cancer diagnoses.

More common in individuals with little to no smoking history, the ROS1 gene alteration occurs in only up to 2% of NSCLC patients and is associated with aggressive lung cancer that can often spread to the brain.

Augtyro, which is a tyrosine kinase inhibitor (TKI) designed to minimise interactions that can lead to certain forms of treatment resistance in ROS1-positive metastatic NSCLC patients, was added to BMS’ oncology portfolio last year through its $4.1bn acquisition of Turning Point Therapeutics.

The FDA’s decision on the drug was supported by results from the phase 1/2 TRIDENT-1 study that evaluated Augtyro in patients with advanced solid tumours, including NSCLC, who had previously received treatment with another TKI and those who had not.

Augtyro demonstrated an objective response rate, defined as the percentage of patients whose tumour size decreased or who no longer have signs of cancer, of 79% in those who had not previously received any TKI treatment and 38% in those pretreated with one prior ROS1 TKI and no prior chemotherapy.

Samit Hirawat, executive vice president, chief medical officer, global drug development, BMS, said: “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.”

The FDA’s decision on Augtyro comes just one month after BMS received approval from the US regulator for its PD-1 immune checkpoint inhibitor Opdivo (nivolumab) in adults and adolescents with completely resected stage 2B or 2C melanoma.

Opdivo, which utilises the body’s own immune system to help restore an anti-tumour immune response, also holds approvals in more than 65 countries for a range of indications, including NSCLC.

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