Nuvation Bio's Ibtrozi Gets Japan Approval for Advanced ROS1-positive Non-Small Cell Lung Cancer

MT Newswires Live

09/19

Nuvation Bio (NUVB) said Friday that Japan's Ministry of Health, Labour and Welfare has approved its Ibtrozi therapy to treat adult patients with advanced ROS1-positive non-small cell lung cancer.

The company said that Nippon Kayaku will market Ibtrozi in Japan as part of a previously signed agreement in 2023.

The approval from Japan was based on data from a phase 2 clinical study researching Ibtrozi in patients globally, including Japan, the company said.

The company said that when the reimbursement price in Japan is set, which is expected in Q4, it will receive a $25 million milestone payment to advance its pipeline and portfolio.

Nuvation Bio added that Japan's Ministry of Health, Labour and Welfare has also approved AmoyDx PLC Panel as a companion diagnostic to identify patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer who may benefit from treatment with Ibtrozi.

Shares of the company were up 2.1% in recent Friday premarket activity.

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