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 ...

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 ...

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 ...

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+) ...

(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 ...

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 targets ROS1-positive NSCLC, showing promise in overcoming resistance mutations and CNS metastases with brain penetrance. The ARROS-1 trial demonstrated significant response rates in TKI ...

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 ...