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The US Food and Drug Administration said on Wednesday it has approved Nuvation Bio's drug for patients with a rare and aggressive form of lung cancer.
The once-daily oral drug, with the brand name Ibtrozi, is approved to treat ROS1-positive non-small cell lung cancer (NSCLC), which results from changes in the ROS1 gene leading to uncontrolled cell growth.
The disease accounts for about 2% of new NSCLC cases, or about 3,000 new diagnoses annually in the US, according to the company.
ROS1-positive patients tend to be younger than the average patient with lung cancer and have little to no smoking history, according to the American Lung Association.
Shares of the company fell 17.4% to $2.09.
RBC Capital Markets analyst Leonid Timashev estimates about $640 million in peak revenue for Ibtrozi in 2034, and added, "With shares down 15-20%, we think downside is overdone on any potential launch and label optics concerns."
Ibtrozi will be priced at $29,488 per month and will be available in the next few weeks, the company said.
The approval of the drug, taletrectinib, was based on results from two mid-stage trials in which the drug demonstrated high response rates with durable benefit, the company added.
The drug, which is a ROS1 inhibitor, works by targeting the ROS1 gene fusions.
Other approved ROS1 inhibitors include Bristol-Myers Squibb's Augtyro, Pfizer's Xalkori and Roche's Rozlytrek.
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