Certain patients with non-small cell lung cancer who are treatment-naive may benefit from receiving a biopsy regarding treatment decision-making. Receiving genomic testing (looking for cancer cells ...

Ibtrozi is a medicine called a kinase inhibitor that is used to treat a certain type of lung cancer called non-small-cell lung cancer (NSCLC) that is caused by an abnormal ROS1 gene. NSCLC is the most ...

The U.S. Food and Drug Administration (FDA) on Wednesday approved Nuvation Bio Inc.’s (NASDAQ:NUVB) Ibtrozi (taletrectinib) for adult patients with locally advanced or metastatic ROS1-positive (ROS1+) ...

The FDA has approved taletrectinib (Ibtrozi, Nuvation Bio) for locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) in first- and later-line settings, regardless of prior ...

An expert explained what ROS1-positive non-small cell lung cancer is and why it is important to identify mutations like ROS1 through genetic sequencing. ROS1-positive non-small cell lung cancer, a ...

Zidesamtinib is a novel brain-penetrant ROS1-selective inhibitor created with the aim to overcome limitations observed with currently available ROS1 inhibitors. Zidesamtinib is designed to remain ...

The drug is under Priority Review by the U.S. Food and Drug Administration (FDA) and has a Prescription Drug User Fee Act (PDUFA) date of June 23, 2025 NEW YORK--(BUSINESS WIRE)--Nuvation Bio Inc.

Nuvalent (NASDAQ:NUVL) reported promising results from its mid-stage trial for zidesamtinib, a new drug that specifically targets ROS1, in patients with advanced ROS1-positive non-small cell lung ...

The FDA approved taletrectinib (Ibtrozi)-- a next-generation oral ROS1 tyrosine kinase inhibitor (TKI) -- for the treatment of adults with locally advanced or metastatic ROS1-positive non-small cell ...

The US Food and Drug Administration (FDA) has granted accelerated approval to entrectinib (Rozlytrek, Genentech/Roche) today for the treatment of adult and pediatric patients with a variety of tumors ...

Rolling NDA submission for zidesamtinib in TKI pre-treated advanced ROS1-positive NSCLC initiated under FDA's RTOR program, with completion on track for the third quarter of 2025 CAMBRIDGE, Mass., ...