Nuvation Bio received U.S. Food and Drug Administration (FDA) approval for a supplemental New Drug Application for Ibtrozi (taletrectinib) four months ahead of schedule. The updated label includes new clinical data for patients with advanced ROS1-positive non-small cell lung cancer (NSCLC).
The mid-stage TRUST-I study demonstrated a median duration of response of 49.7 months for TKI-naïve patients. This result indicates a sustained clinical benefit of more than four years. The safety profile for Ibtrozi remains unchanged with no new safety signals identified.
Nuvation Bio shares traded higher following the announcement.