US FDA approves Bristol-Myers' lung cancer drug

[November 16, 2023]  (Reuters) -The U.S. Food and Drug Administration (FDA) has approved Bristol-Myers Squibb's lung cancer drug that was acquired as part of the company's $4.1 billion buyout of Turning Point Therapeutics last year.

The drug, to be sold under the brand name Augtyro, is set to compete in a crowded market for lung cancer treatments that includes Bristol Myers' other cancer treatment Opdivo and rival cancer drugs from Roche, Merck and AstraZeneca.

Augtyro will be available in the United States in mid-December this year, Bristol Myers said in a statement.

The FDA said on Wednesday that the approval allows the use of the drug to treat patients with ROS1-positive non-small cell lung cancer (NSCLC), which occurs when the ROS1 gene fuses with another nearby gene and drives abnormal cell growth.

The ROS1 gene alteration occurs in about 1% to 2% of lung cancer patients, according to the American Lung Association, and is more common in patients with little to no smoking history.

Augtyro, chemically known as repotrectinib, belongs to a class of treatments known as tyrosine kinase inhibitors (TKI). It targets mutations in certain proteins in the body that lead to unchecked cell growth.

A sign stands outside a Bristol Myers Squibb facility in Cambridge, Massachusetts, U.S., May 20, 2021. REUTERS/Brian Snyder/File Photo/File Photo

The FDA approval is based on data from a trial in which the oral drug was given to cancer patients who had previously received treatment with another TKI, and those who had not, the company said.

In the study, the treatment helped shrink or reduce tumor in 79% of patients who had not previously received any TKI treatment and in 38% of patients who were previously treated with a drug from the same class.

Bristol Myers previously said it expects the drug to become a standard-of-care therapy for certain patients with NSCLC, a lucrative market for drug developers.

(Reporting by Bhanvi Satija in Bengaluru; Additional reporting by Maria Ponnezhath; Editing by Devika Syamnath and Subhranshu Sahu)

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