FDA priority review for Nuvation Bio's taletrectinib

New York-based Nuvation Bio (Nasdaq: NUVB) today revealed that the US Food and Drug Administration (FDA) has accepted the company’s new drug application (NDA) for taletrectinib, an investigational next-generation ROS1 tyrosine kinase inhibitor (TKI) for the treatment of advanced ROS1+ NSCLC (line agnostic), for priority review.

Nuvation’s shares were up 3.4% at $2.78 following the announcement.

This NDA is based on pooled data from the pivotal Phase II TRUST-1 and TRUST-II studies of taletrectinib that demonstrated durable responses and prolonged progression-free survival in patients with advanced (ROS1+) non-small cell lung cancer (NSCLC). If approved, taletrectinib represents a potential best-in-class treatment option for patients with advanced ROS1+NSCLC. The FDA has assigned a target action date of June 23, 2025, the company noted.