# IBTROZI (taletrectinib) PDUFA Event: Advanced ROS1-positive non-small cell lung cancer — updated response and duration-of-response data

Canonical URL: https://biopharmsignal.com/pdufa-calendar/NUVB/ibtrozi-updated-duration-response-ros1-positive-nsclc

Ticker: NUVB

Company: Nuvation Bio

Event date: 2027-01-04

Event type: FDA Decision

Stage: PDUFA

Result: Approved

Result date: 2026-09-16

Application type: sNDA

FDA approved the sNDA ahead of the PDUFA date. FDA approved the label supplement to add updated TRUST-I and TRUST-II response and duration-of-response data;...

## Event Timeline

### September 16, 2026 — FDA approved the sNDA ahead of the PDUFA date

FDA approved the label supplement to add updated TRUST-I and TRUST-II response and duration-of-response data; the approval letter records the action as effective on September 16, 2026.

[FDA — IBTROZI sNDA approval letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/219713Orig1s004ltr.pdf)

### January 4, 2027 — Original PDUFA target action date

FDA had assigned January 4, 2027 as the target action date for the sNDA, which was submitted to fulfill a postmarketing commitment.

[Nuvation Bio — sNDA acceptance and target action date](https://www.prnewswire.com/news-releases/nuvation-bio-announces-fda-acceptance-of-supplemental-new-drug-application-for-ibtrozi-taletrectinib-with-updated-duration-of-response-in-advanced-ros1-positive-non-small-cell-lung-cancer-302763329.html)

### May 6, 2026 — FDA accepted the sNDA for review

The supplement included an additional 10 months of TRUST-I and TRUST-II follow-up, with 49.7 months’ median duration of response in TKI-naïve TRUST-I patients and 19.4 months in TKI-pretreated TRUST-II patients.

[Nuvation Bio — updated TRUST data and sNDA acceptance](https://www.prnewswire.com/news-releases/nuvation-bio-announces-fda-acceptance-of-supplemental-new-drug-application-for-ibtrozi-taletrectinib-with-updated-duration-of-response-in-advanced-ros1-positive-non-small-cell-lung-cancer-302763329.html)

## Related Pages

- NUVB PDUFA calendar: https://biopharmsignal.com/pdufa-calendar/NUVB.md

- NUVB company profile: https://biopharmsignal.com/company/NUVB.md

- PDUFA calendar: https://biopharmsignal.com/pdufa-calendar.md