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News
The FDA cleared a supplemental new drug application for taletrectinib (Ibtrozi), updating its label with long-term data showing a median duration of response of 49.7 months in treatment-naive ROS1+ non-small cell lung cancer patients — the longest median DOR ever reported for an FDA-approved ROS1 TKI. The decision came four months ahead of its scheduled review date.
The FDA has cleared a supplemental new drug application (sNDA) for taletrectinib (Ibtrozi), updating its prescribing label with longer-term efficacy data from the phase 2 TRUST-I and TRUST-II trials. The headline number: a median duration of response (DOR) of 49.7 months in treatment-naive patients with locally advanced or metastatic ROS1-positive NSCLC — the longest median DOR ever reported for an FDA-approved ROS1 TKI. The decision arrived four months ahead of its Prescription Drug User Fee Act target date.
The updated pooled data (n=157 TKI-naive patients) showed an overall response rate of 89.8%, a median progression-free survival of 46.1 months, and a median overall survival that has not yet been reached. Even in patients who had previously received a ROS1 TKI, taletrectinib showed meaningful activity, with response rates of 52–62% and a median DOR of approximately 13–17 months.
By the Numbers:
Why it matters: Having this long-term DOR data officially on the FDA label gives physicians and patients a concrete, evidence-backed picture of how durable responses can be — a meaningful reassurance for patients newly diagnosed with ROS1+ NSCLC as they weigh their treatment options.
