Nuvation Bio (NUVB) has upcoming FDA regulatory milestones for IBTROZI. The table below outlines estimated target dates and event types for these pending regulatory actions.
This section highlights FDA-related milestones and regulatory updates for drugs developed by Nuvation Bio (NUVB).
Over the past two years, Nuvation Bio has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
IBTROZI, Safusidenib, and Taletrectinib. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
IBTROZI FDA Regulatory Timeline and Events
IBTROZI is a drug developed by Nuvation Bio for the following indication: In Advanced ROS1-Positive Non-Small Cell Lung Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- IBTROZI
- Announced Date:
- May 6, 2026
- Target Action Date:
- January 4, 2027
- Indication:
- In Advanced ROS1-Positive Non-Small Cell Lung Cancer
Announcement
Nuvation Bio Inc announced today that the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) with updated data for IBTROZI® (taletrectinib) in both TKI-naïve and TKI-pretreated advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) with a target action date of January 4, 2027.
AI Summary
Nuvation Bio announced that the U.S. Food and Drug Administration has accepted a supplemental New Drug Application (sNDA) for IBTROZI® (taletrectinib) to support use in both TKI‑naïve and TKI‑pretreated advanced ROS1‑positive non‑small cell lung cancer (NSCLC). The filing includes updated results from the TRUST studies: in TKI‑naïve patients (TRUST‑I) the median duration of response and median progression‑free survival exceeded four years, and in TKI‑pretreated patients (TRUST‑II) the median duration of response was nearly 20 months.
The FDA has assigned a target action date of January 4, 2027. IBTROZI is indicated for adults with locally advanced or metastatic ROS1+ NSCLC. These updated data aim to support treatment options for both patients who have not received ROS1 TKIs and those who have, with final decisions and any labeling or safety details to be determined by the FDA review.
Read Announcement- Drug:
- IBTROZI
- Announced Date:
- May 6, 2026
- Indication:
- In Advanced ROS1-Positive Non-Small Cell Lung Cancer
Announcement
Nuvation Bio Inc announced today that the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) with updated data for IBTROZI® (taletrectinib) in both TKI-naïve and TKI-pretreated advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) with a target action date of January 4, 2027.
AI Summary
Nuvation Bio announced the U.S. Food and Drug Administration has accepted a supplemental New Drug Application (sNDA) for IBTROZI® (taletrectinib) in both TKI‑naïve and TKI‑pretreated advanced ROS1‑positive non‑small cell lung cancer, with a target action date of January 4, 2027. The submission includes updated results from the TRUST trials: TRUST‑I reports both median duration of response (mDOR) and median progression‑free survival (mPFS) of more than four years in TKI‑naïve patients, while TRUST‑II shows a TKI‑pretreated mDOR of nearly 20 months. These data point to durable responses in patients treated earlier and later in their disease course.
IBTROZI is indicated for adults with locally advanced or metastatic ROS1+ NSCLC. The FDA’s review will determine whether these updated data support changes to the drug’s labeling or broader use in this patient population.
Read Announcement- Drug:
- IBTROZI
- Announced Date:
- March 17, 2026
- Indication:
- In Advanced ROS1-Positive Non-Small Cell Lung Cancer
Announcement
Nuvation Bio Inc. announced that new data will be presented at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2026 taking place April 17–22, 2026, in San Diego, California.
AI Summary
Nuvation Bio announced it will present new clinical data at the American Association for Cancer Research (AACR) Annual Meeting, April 17–22, 2026, in San Diego. The presentations will focus on taletrectinib (IBTROZI) in ROS1‑positive non‑small cell lung cancer (NSCLC), including updated durability and outcomes in different patient groups.
Updated results show unprecedented durability in TKI‑naïve advanced ROS1+ NSCLC, with median duration of response (DOR) increased to 50 months as of the August 2025 data cutoff. Presentations will also highlight efficacy and safety data for taletrectinib in patients previously treated with TKIs. IBTROZI is indicated in the U.S. for adults with locally advanced or metastatic ROS1+ NSCLC.
Key safety issues include liver enzyme elevations that may require dose changes, interstitial lung disease/pneumonitis (including a fatal case), QTc prolongation, hyperuricemia, and myalgia with CPK rise. Common side effects reported include diarrhea, nausea, vomiting, dizziness, rash, constipation, and fatigue; some adverse events led to dose interruptions, reductions, or rare discontinuations.
Read Announcement- Drug:
- IBTROZI
- Announced Date:
- September 30, 2025
- Indication:
- In Advanced ROS1-Positive Non-Small Cell Lung Cancer
Announcement
Nuvation Bio Inc announced it has enrolled the first patient in TRUST-IV (NCT07154706), a Phase 3 study evaluating the efficacy and safety of IBTROZI™ (taletrectinib), a next-generation ROS1 inhibitor, versus placebo for the adjuvant treatment of patients with resected ROS1-positive (ROS1+) early-stage non-small cell lung cancer (NSCLC).
AI Summary
Nuvation Bio Inc. has enrolled the first patient in TRUST-IV (NCT07154706), a global Phase 3 study comparing IBTROZI™ (taletrectinib) to placebo as an adjuvant treatment for patients with resected ROS1-positive early-stage non-small cell lung cancer (NSCLC). The trial plans to enroll about 180 patients across the U.S., Canada, Europe, Japan and China. Eligible participants must have stage IB, II or IIIA ROS1+ NSCLC, have undergone surgical resection, and received only standard platinum-based chemotherapy afterward.
Patients will be randomized 2:1 to receive daily taletrectinib or placebo. The main goal is to assess disease-free survival as judged by investigators. TRUST-IV’s primary completion date is estimated in 2033.
Alexander Drilon, M.D., from Memorial Sloan Kettering Cancer Center, noted the need for targeted options to prevent recurrence after surgery. David Hung, M.D., CEO of Nuvation Bio, said this trial marks important progress in expanding taletrectinib’s use to earlier-stage disease.
Read Announcement- Drug:
- IBTROZI
- Announced Date:
- September 7, 2025
- Indication:
- In Advanced ROS1-Positive Non-Small Cell Lung Cancer
Announcement
Nuvation Bio Inc. announced new and updated results from the pivotal Phase 2 TRUST-I and TRUST-II studies evaluating IBTROZI™ (taletrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC).
AI Summary
Nuvation Bio announced new and updated Phase 2 TRUST-I and TRUST-II results for IBTROZI in ROS1-positive non-small cell lung cancer. Over 300 adults with locally advanced or metastatic disease were enrolled worldwide. The data were presented at the IASLC 2025 World Conference on Lung Cancer in Barcelona.
In TKI-naïve patients, TRUST-I achieved a 90.3% confirmed response rate and a median progression-free survival (PFS) of 44.6 months. In TRUST-II, the response rate was 85.2%, median PFS wasn’t reached after 20.5 months, and over half of patients remained progression-free at data cut-off. Intracranial responses occurred in most patients with brain metastases, underscoring sustained durability of response.
The pooled safety analysis of 337 patients showed a manageable tolerability profile. Common adverse events—diarrhea, nausea, vomiting, and dizziness—were transient and resolved in 1–3 days, causing few treatment interruptions. Elevated liver enzymes led to one treatment discontinuation.
Read Announcement- Drug:
- IBTROZI
- Announced Date:
- August 5, 2025
- Indication:
- In Advanced ROS1-Positive Non-Small Cell Lung Cancer
Announcement
Nuvation Bio Inc announced that new data will be presented at the IASLC 2025 World Conference on Lung Cancer (WCLC) taking place September 6–9, 2025 in Barcelona, Spain, and the European Society of Medical Oncology Congress Meeting(ESMO) October 17–21, 2025 in Berlin, Germany.
AI Summary
Nuvation Bio Inc. announced that new data will be presented at the IASLC 2025 World Conference on Lung Cancer (WCLC) September 6–9 in Barcelona, Spain, and at the European Society for Medical Oncology (ESMO) Congress October 17–21 in Berlin, Germany.
The presentations will feature updated and additional Phase 2 clinical data from the TRUST-I and TRUST-II studies on IBTROZI™ (taletrectinib). These trials assess the efficacy and safety of this next-generation oral tyrosine kinase inhibitor in adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer.
At WCLC, sessions will include global and China-specific TRUST results, a Phase 3 head-to-head study versus crizotinib, clinical pharmacology insights, and preclinical profiles. Nuvation Bio will also sponsor a satellite symposium titled “Under the Microscope: Focusing on ROS1+ NSCLC.”
During ESMO, the TRUST-II global study on taletrectinib after prior entrectinib exposure will be presented as a poster. All presentation materials will be made available in the Publications section of Nuvation Bio’s website.
Read Announcement
Safusidenib FDA Regulatory Events
Safusidenib is a drug developed by Nuvation Bio for the following indication: Treatment of Grade 2 IDH1-Mutant Glioma in Neuro-Oncology.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Safusidenib
- Announced Date:
- February 9, 2026
- Indication:
- Treatment of Grade 2 IDH1-Mutant Glioma in Neuro-Oncology
Announcement
Nuvation Bio Inc announced finalization of a protocol amendment to the ongoing global SIGMA study (also known as G203; NCT05303519) of safusidenib that expands it to a Phase 3 trial.
AI Summary
Nuvation Bio announced it has finalized a protocol amendment that expands the ongoing global SIGMA study (G203; NCT05303519) of safusidenib from a Phase 2 into a Phase 3 trial. The amended design adds patients with grade 2 astrocytoma who have high‑risk features in the maintenance setting, alongside the previously eligible high‑grade astrocytoma patients, broadening the trial’s reach across IDH1‑mutant gliomas.
The amendment also creates a new exploratory cohort for patients with grade 3 oligodendroglioma in the post‑surgical setting and a non‑pivotal single‑arm cohort to evaluate safusidenib in chemotherapy‑ and radiotherapy‑naïve grade 3 IDH1‑mutant oligodendroglioma. That single‑arm cohort will use objective response rate as its primary endpoint and is expected to enroll about 40 patients. Safusidenib is an oral, brain‑penetrant inhibitor of mutant IDH1 that showed tolerability and anti‑tumor activity in earlier studies, and SIGMA now targets a broad group of patients without approved targeted treatment options.
Read Announcement- Drug:
- Safusidenib
- Announced Date:
- December 3, 2025
- Indication:
- Treatment of Grade 2 IDH1-Mutant Glioma in Neuro-Oncology
Announcement
Nuvation Bio Inc announced the publication of positive results from a Phase 2 study of safusidenib, a novel, oral, potent, brain-penetrant targeted inhibitor of mutant IDH1, in patients with chemotherapy- and radiotherapy-naïve grade 2 IDH1-mutant gliomas.
AI Summary
Nuvation Bio reported positive Phase 2 results for safusidenib, an oral, brain‑penetrant inhibitor of mutant IDH1, in patients with chemotherapy‑ and radiotherapy‑naïve grade 2 IDH1‑mutant gliomas. The open‑label, multicenter, single‑arm study enrolled 27 patients and was published in Neuro‑Oncology. With a data cut‑off of March 10, 2023 and a median follow‑up of 28 months, the trial met its primary endpoint, showing an objective response rate (ORR) of 44.4% and a median progression‑free survival that was not yet reached.
Responses were durable: 87.9% of patients were progression‑free at 24 months. Adverse events were mostly mild or moderate; 18.5% experienced treatment‑related grade 3 or higher events and 11.1% discontinued due to treatment‑emergent adverse events (two considered related to safusidenib), which resolved with management. A Good Clinical Practice noncompliance in adverse event collection was identified and safety data were subsequently re‑investigated and re‑collected to ensure data integrity.
Read Announcement
Taletrectinib (ROS1+ NSCLC) FDA Regulatory Timeline and Events
Taletrectinib (ROS1+ NSCLC) is a drug developed by Nuvation Bio for the following indication: For Patients with Advanced ROS1-positive NSCLC.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Taletrectinib (ROS1+ NSCLC)
- Announced Date:
- March 6, 2025
- Indication:
- For Patients with Advanced ROS1-positive NSCLC
Announcement
Nuvation Bio Inc provided a business update.
AI Summary
Nuvation Bio Inc. recently provided a business update highlighting a transformative year in 2024. The company acquired AnHeart Therapeutics, reported positive pivotal data for taletrectinib, and submitted the New Drug Application, which was accepted for Priority Review by the FDA. With a PDUFA goal date set for June 23, 2025, taletrectinib is positioned for potential U.S. commercial launch. The company also launched an Expanded Access Program in February 2025 to help patients with advanced ROS1-positive non-small cell lung cancer. Additionally, Nuvation Bio secured up to $250 million in non-dilutive financing from Sagard Healthcare Partners, which is expected to fully fund the U.S. launch of taletrectinib. The management expressed optimism for further updates in 2025 from other pipeline programs such as safusidenib and NUV-1511, reinforcing its commitment to addressing unmet needs in oncology.
Read Announcement- Drug:
- Taletrectinib (ROS1+ NSCLC)
- Announced Date:
- January 6, 2025
- Indication:
- For Patients with Advanced ROS1-positive NSCLC
Announcement
Nuvation Bio Inc announced that China's National Medical Products Administration (NMPA) has approved taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) who either have or have not been previously treated with ROS1 tyrosine kinase inhibitors (TKI).
AI Summary
Nuvation Bio Inc announced that China's National Medical Products Administration (NMPA) has approved taletrectinib for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). This approval applies to patients who have or have not been previously treated with ROS1 tyrosine kinase inhibitors, offering a new treatment option regardless of past therapies. The decision was supported by data from the pivotal Phase 2 TRUST-I study, which demonstrated durable responses and prolonged progression-free survival in treated patients.
Innovent Biologics will market taletrectinib in China under the brand name DOVBLERON®, with the product officially launching in January 2025. This milestone marks an important step forward in addressing critical treatment needs for patients with ROS1-positive NSCLC, reinforcing taletrectinib’s potential as a best-in-class therapy in oncology.
Read Announcement- Drug:
- Taletrectinib (ROS1+ NSCLC)
- Announced Date:
- September 14, 2024
- Target Action Date:
- Q4 2024
- Estimated Target Date Range:
- October 1, 2024 - December 31, 2024
- Indication:
- For Patients with Advanced ROS1-positive NSCLC
Announcement
Nuvation Bio plans to submit a New Drug Application (NDA) for taletrectinib to the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2024
AI Summary
Nuvation Bio Inc. announced that it plans to submit a New Drug Application (NDA) for taletrectinib to the U.S. Food and Drug Administration in the fourth quarter of 2024. This next-generation, oral ROS1 tyrosine kinase inhibitor is being developed for patients with advanced ROS1-positive non-small cell lung cancer. The NDA submission is supported by promising results from ongoing Phase 2 studies, which have shown durable responses and prolonged progression-free survival. Taletrectinib’s robust clinical data, including significant tumor shrinkage and a favorable safety profile, have reinforced its potential as an effective treatment option for lung cancer. If the FDA approves the therapy, it is expected that taletrectinib could be launched in the U.S. in 2025, offering a new option for patients in need of improved treatment outcomes.
Read Announcement- Drug:
- Taletrectinib (ROS1+ NSCLC)
- Announced Date:
- September 14, 2024
- Indication:
- For Patients with Advanced ROS1-positive NSCLC
Announcement
Nuvation Bio Inc announced positive pooled data from the pivotal Phase 2 TRUST-I and TRUST-II studies evaluating taletrectinib, an investigational next-generation ROS1 TKI.
AI Summary
Nuvation Bio Inc announced positive pooled results from its pivotal Phase 2 TRUST-I and TRUST-II studies on taletrectinib, an investigational next-generation ROS1 tyrosine kinase inhibitor (TKI) for advanced ROS1-positive non-small cell lung cancer. The data showed significant tumor shrinkage, with 89% of TKI-naïve patients and 56% of TKI-pretreated patients benefiting from the treatment. In TKI-naïve patients, the results were particularly promising with a median duration of response of 44 months and a median progression-free survival of 46 months, indicating durable responses.
The safety profile was favorable, with low rates of treatment-emergent neurologic events and minimal treatment discontinuation. These encouraging findings support Nuvation Bio's planned New Drug Application submission to the FDA in the fourth quarter of 2024, aiming to bring taletrectinib to market by 2025.
Read Announcement
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