The drug has also received Breakthrough Therapy and Orphan Drug designations from the U.S. FDA for the treatment of ROS1+ NSCLC. This news is based on a press release statement from Nuvation Bio Inc.

The deal gave Nuvation ownership of AnHeart's drug candidate taletrectinib, referred to in a press release announcing the deal as: a next-generation, potentially best-in-class ROS1 inhibitor with ...

During a Case-Based Roundtable® event, Vamsidhar Velcheti, MD, discussed the TRIDENT-1 trial and practical considerations for ...

The EAP, as authorized by the U.S. Food and Drug Administration (FDA), allows patients with serious or immediately life-threatening ROS1+ NSCLC to access taletrectinib outside of the ongoing ...

AnHeart describes taletrectinib as a “next-generation” ROS1 inhibitor that could improve on other drugs in the class, like Pfizer’s first-to-market Xalkori (crizotinib), for example ...

Taletrectinib was previously given Orphan Drug and Breakthrough Therapy Designations ... therapy taletrectinib in the treatment of advanced ROS1+ non-small cell lung cancer. The agency has set ...

Nuvation Bio Inc. (NYSE: NUVB), a global biopharmaceutical company tackling some of the greatest unmet needs in oncology, today reported financial results for the fourth quarter and full year ended ...

accepted and granted Priority Review to the New Drug Application (NDA) for taletrectinib for advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC); Prescription Drug User Fee Act ...