HQ Team
June 11, 2025: The US Food and Drug Administration has approved Nuvation Bio Inc.’s medicine for adults who have a rare type of lung cancer caused by a specific genetic change.
Taletrectinib, branded as Ibtrozi by Nuvation Bio, is meant to treat ROS1-positive non-small cell lung cancer. This type of lung cancer has a specific genetic change (called ROS1-positive) that causes the cancer cells to grow uncontrollably.
It is a rare form found in about 1-2% of lung cancer patients, often in younger people and non-smokers.
Taletrectinib belongs to a group of drugs known as kinase inhibitors. It works by blocking the activity of a protein called kinases that helps the cancer grow.
Kinases act like switches that tell cells to grow and divide. In cancer, some kinases get stuck in the “on” position, causing uncontrolled growth. Taletrectinib is a kinase inhibitor that blocks the faulty ROS1 protein.
Tumours shrink
To test how well this medicine works, two clinical studies were done with patients who had ROS1-positive lung cancer. Some patients had never been treated with similar drugs before, while others had already tried one such drug.
For patients who had never taken a ROS1-targeting drug before, about 85-90% saw their tumours shrink or disappear after treatment. Most of these patients kept this improvement for at least a year.
In patients who had already been treated with a similar drug, between 52% and 62% responded to taletrectinib, with most showing the benefit lasting for at least six months.
The FDA granted priority review, breakthrough designation, and orphan drug designation to Nuvation Bio’s application.
