Nuvation Bio's Supplemental NDA With Updated Data For IBTROZI Wins FDA Acceptance

(RTTNews) - Wednesday, Nuvation Bio Inc. (NUVB) announced that the U.S. Food and Drug Administration has accepted a supplemental New Drug Application with updated data for IBTROZI for the treatment of advanced ROS1-positive non-small cell lung cancer, with a target action date of January 4, 2027.

The submission includes an additional 10 months of data from the pivotal TRUST-I and TRUST-II studies as of an August 2025 data cutoff, further validating the overall clinical profile with long-term follow-up.

These findings revealed that IBTROZI demonstrated a median duration of response of 49.7 months and a median progression-free survival of 49.6 months in TKI-naïve patients in TRUST-I. However, the median duration of response had not yet been reached in TKI-naïve patients in the TRUST-II study at the time of the data cutoff.

In the pre-market hours, NUVB is trading at $4.90, up 1.87 percent on the New York Stock Exchange.