(RTTNews) - Nuvation Bio Inc. (NUVB), announced that the U.S. FDA has approved a sNDA for IBTROZI, updating the drug's label to include new long-term efficacy data for treatment-naïve patients with advanced ROS1+ NSCLC.
ROS1+ NSCLC (non-small cell lung cancer) is a rare molecular subtype of lung cancer driven by ROS1 gene rearrangements. Patients often require targeted therapies capable of delivering durable responses, especially in the treatment-naïve setting.
IBTROZI (taletrectinib), is a next-generation ROS1 tyrosine kinase inhibitor designed to target ROS1-positive tumors with improved selectivity and CNS penetration. It is approved for adults with advanced ROS1+ NSCLC and has shown durable responses in both TKI-naïve and TKI-pretreated patients.
The revised label now incorporates data from the TRUST-I study showing a median duration of response (DOR) of 49.7 months— more than four years— in TKI-naïve patients, representing the longest median DOR reported for any FDA-approved ROS1 Tyrosine kinase inhibitor to date.
The approval reflects a median follow-up of 51 months, including an additional 14 months of data from both TRUST-I and TRUST-II as of the August 2025 cutoff.
The FDA noted no changes to the safety sections of the IBTROZI label. No new safety signals were identified with extended follow-up, reinforcing the therapy's tolerability over long-term use.
Nuvation Bio stated that having multi-year durability data directly reflected in the FDA-approved label provides physicians and patients with clearer expectations regarding treatment longevity and strengthens the rationale for using IBTROZI early in the care pathway.
Many patients in the TRUST studies remained on therapy for several years with sustained responses, underscoring the drug's long-term benefit and its importance as a treatment option for advanced ROS1+ NSCLC.
CEO David Hung, M.D., called the approval a "significant milestone," noting that the updated label gives patients "more confidence in what their treatment path could look like" and provides physicians with stronger evidence supporting early use of IBTROZI in ROS1-positive disease.
NUVB has traded between $2.99 and $9.75 over the past year. The stock closed Wednesday's trading at $5.78, down 0.34%. In pre-market trading the stock is at $5.96, up 3.07%.