Taletrectinib, a next-generation TKI, is approved for ROS1-positive NSCLC, showing high ORR and durable responses in clinical trials. TRUST-I and TRUST-II trials demonstrated efficacy in both ...

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.

NEW YORK--(BUSINESS WIRE)--Nuvation Bio Inc. (NYSE: NUVB), a global biopharmaceutical company tackling some of the greatest unmet needs in oncology, today announced it has initiated an Expanded Access ...

(Barcelona, Spain September 7, 2025, 10:45 a.m. CEST / UTC +2 ) — Zidesamtinib, an investigational next-generation ROS1 tyrosine kinase inhibitor (TKI) designed to be highly selective, brain-penetrant ...

An expert discusses the personalized approach to treating ROS1-positive non-small cell lung cancer, emphasizing the preference for next-generation TKIs like taletrectinib and repotrectinib due to ...

Zidesamtinib achieved a 44% ORR and 1% CR rate in advanced ROS1-positive NSCLC patients previously treated with ROS1 TKIs. The ARROS-1 trial showed zidesamtinib's efficacy, especially in patients with ...

Taletrectinib's NDA is based on phase 2 TRUST-I and TRUST-II trials, showing significant efficacy in ROS1-positive NSCLC. The trials reported tumor shrinkage in 89% of TKI-naive and 56% of ...

Nuvation Bio (NUVB) announced that the U.S. FDA has accepted the company’s NDA for taletrectinib, an investigational next-generation ROS1 tyrosine kinase inhibitor TKI , for the treatment of advanced ...

Zidesamtinib, an investigational next-generation ROS1 tyrosine kinase inhibitor (TKI) designed to be highly selective, brain-penetrant, and TRK-sparing, demonstrated clinically meaningful activity and ...

Nuvation Bio's Taletrectinib shows promising data in phase 2 trials for ROS1-positive NSCLC, outperforming current market leaders in key metrics like DOR and PFS. Despite a small target market, ...