Nuvation Bio Announces FDA Approval of Supplemental New Drug Application for IBTROZI® (taletrectinib) with Updated Duration of Response in TKI-Naïve Advanced ROS1-Positive Non-Small Cell Lung Cancer

FDA adds nearly 50‑month median response duration for IBTROZI in TKI‑naïve ROS1+ NSCLC without changing the established safety profile.

Rhea-AI Summary

Nuvation Bio (NUVB) received FDA approval of a supplemental New Drug Application for IBTROZI (taletrectinib) updating efficacy data in TKI‑naïve advanced ROS1‑positive NSCLC.

The U.S. label now includes a median duration of response of 49.7 months in TKI‑naïve patients from the Phase 2 TRUST‑I study, based on a median follow‑up of 51 months and an additional 14 months of data from TRUST‑I and TRUST‑II as of an August 2025 cutoff. The update was granted four months ahead of the PDUFA date and made with no changes to the safety sections of the label and no new safety signals identified, confirming the existing safety profile. IBTROZI already has full FDA approval (June 2025) for adult patients with locally advanced or metastatic ROS1+ NSCLC and is approved in Japan and China, while MAAs are under review by the EMA and the UK MHRA.

Positive

• Median DOR 49.7 months in TKI‑naïve TRUST‑I patients now on U.S. label
• sNDA approval granted four months before the PDUFA target date
• Label update based on 51‑month median follow‑up and extra 14 months of data
• No new safety signals and no changes to safety sections of labeling
• IBTROZI fully approved in U.S. since June 2025 across ROS1+ NSCLC lines
• Drug already approved in Japan and China, with MAAs validated by EMA and MHRA

Negative

• Fatal liver events in 0.6% of IBTROZI‑treated patients; Grade 3/4 ALT in 13%, AST in 10%
• ILD/pneumonitis in 2.3% of patients, including a fatal case and 1.1% Grade 3/4
• QTcF increase >60 msec in 13% and QTcF >500 msec in 2.6% of patients; 3.4% Grade ≥3
• Hyperuricemia reported in 14% of patients, with some needing urate‑lowering therapy
• Skeletal fractures in 3.4% of patients, including 1.4% Grade 3 events
• Common adverse reactions (≥20%) include diarrhea 64%, nausea 47%, vomiting 43%, dizziness 22%, rash 22%, constipation 21%, fatigue 20%

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Market Reaction – NUVB

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Following this news, NUVB has gained 3.45%, reflecting a moderate positive market reaction. Our momentum scanner has triggered 2 alerts so far, indicating moderate trading interest and price volatility. The stock is currently trading at $6.00. Trading volume is exceptionally heavy at 8.0x the average, suggesting very strong buying interest.

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Market Context

On Sep 15, NUVB shares fell 2.36% after subgroup analyses from the same TRUST-I/II program; the curr...

Analysis

On Sep 15, NUVB shares fell 2.36% after subgroup analyses from the same TRUST-I/II program; the current FDA label update formalized its 49.7-month TKI-naïve median DOR.

Key Figures

Median duration of response: 49.7 months Median follow-up: 51 months Additional data: 14 months +1 more

Median duration of response

49.7 months

TRUST-I TKI-naïve patients

Median follow-up

51 months

TRUST-I study

Additional data

14 months

TRUST-I and TRUST-II studies

Approval timing

4 months ahead

FDA sNDA approval versus PDUFA date

Historical Context

1 past event · Latest: Sep 15

1 event

1. Sep 15

   IBTROZI subgroup analyses

   24h Move

   -2.4%

   Reported durable TRUST-I/II efficacy across TKI-naïve patient subgroups with no new safety signals.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

snda, pdufa, duration of response, tki-naïve

4 terms

snda regulatory

"approved a supplemental New Drug Application (sNDA) for IBTROZI"

A SNDA (Subordination, Non‑Disturbance and Attornment Agreement) is a legal pact among a property owner’s lender, the owner’s tenants, and sometimes the landlord that sets who keeps lease rights if the property is sold or a mortgage is enforced. Think of it as a rulebook that decides whether a tenant can stay and keep paying rent or must answer to a new owner after a foreclosure. For investors, an SNDA matters because it protects predictable rental income, clarifies who has priority on claims against a property, and therefore affects a property’s value and the security of related loans.

pdufa regulatory

"Approval comes four months ahead of PDUFA date"

PDUFA is the Prescription Drug User Fee Act, the U.S. law under which drug companies pay fees that fund the FDA's review of new medicines. In company news the term usually appears as the PDUFA date, the target deadline by which the FDA aims to decide on a drug application; that date tells investors when to expect the approval or rejection decision for the product.

duration of response medical

"updated median duration of response (DOR) for the TRUST-I study"

Duration of response is the length of time a patient’s condition stays improved after a treatment until it starts to worsen again; think of it as how long a freshly charged battery continues to power a device. For investors, longer duration of response implies a treatment provides sustained benefit, which can boost a drug’s commercial value, support stronger regulatory labeling and payer coverage, and reduce the need for additional therapies.

tki-naïve medical

"median DOR of 49.7 months in TKI-naïve patients"

TKI‑naïve describes a patient who has never received treatment with a tyrosine kinase inhibitor, a class of targeted drugs that block specific enzymes involved in cancer cell growth. For investors, this matters because therapies and trial results in TKI‑naïve populations can signal a larger potential market and clearer measure of a new drug’s effectiveness, similar to testing a product on first-time users rather than people already using competitors’ products.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Updated label reflects TRUST-I TKI-naïve median duration of response of nearly 50 months

No changes to the safety sections of labeling with longer follow-up and no new safety signals identified

Approval comes four months ahead of PDUFA date

NEW YORK, Sept. 16, 2026 /PRNewswire/ -- Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for IBTROZI^® (taletrectinib), a ROS1 inhibitor approved for the treatment of locally advanced or metastatic ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC).

The updated IBTROZI label now reflects updated median duration of response (DOR) for the TRUST-I study, with a median DOR of 49.7 months in TKI-naïve patients in TRUST-I, reflecting more than four years of sustained clinical benefit. This update came with no changes to the safety sections of labeling, with no new signals identified with longer follow-up, confirming the safety profile.

The sNDA approval reflects a median follow-up of 51 months for patients from the TRUST-I study and incorporates an additional 14 months of data from both of the pivotal TRUST-I and TRUST-II studies as of an August 2025 data cutoff. Many patients remained on therapy for extended periods with a continued response—some for multiple years—highlighting the long-term durability and tolerability of IBTROZI and reinforcing its importance as a treatment option for advanced ROS1+ NSCLC. These data were also presented at the American Association for Cancer Research (AACR) Annual Meeting 2026 and simultaneously published in the Journal of Clinical Oncology.

"This approval is a significant milestone for IBTROZI because this data is now part of the FDA-approved label, something physicians and patients can turn to directly," said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. "A median duration of response of more than four years—the longest median DOR reported for an FDA-approved ROS1 TKI—is a remarkable outcome for people living with ROS1+ NSCLC, and having it in the label means something real for patients: a clearer sense of how long they might expect to stay on treatment, and more confidence in what that path could look like at a moment when a new diagnosis can feel overwhelming. It also gives physicians additional evidence to support using IBTROZI early in a patient's care, when that choice matters most."

The U.S. FDA granted full approval to IBTROZI in June 2025 for the treatment of locally advanced or metastatic ROS1+ NSCLC across lines of therapy. IBTROZI is also approved for patients with advanced ROS1+ NSCLC in Japan, where it is marketed by Nippon Kayaku, and in China, where it is marketed by Innovent Biologics under the brand name DOVBLERON^®. Additionally, the Company, along with its partner, Eisai, announced in March 2026 that the Marketing Authorisation Application (MAA) for taletrectinib was validated by the European Medicines Agency (EMA) for full approval consideration with a standard review timeline, and in June 2026 that the MAA was validated by the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom.

About ROS1+ NSCLC
Each year, more than one million people globally are diagnosed with non-small cell lung cancer (NSCLC), the most common form of lung cancer. It is estimated that approximately 2% of patients with NSCLC have ROS1+ disease. About 35% of patients newly diagnosed with metastatic ROS1+ NSCLC have tumors that have spread to their brain. The brain is also the most common site of disease progression, with about 50% of previously treated patients developing central nervous system (CNS) metastases.

About IBTROZI
IBTROZI is an oral, potent, CNS-active, selective, next-generation ROS1 inhibitor therapy. On June 11, 2025, following Priority Review and Breakthrough Therapy designations for both TKI-naive and TKI-pretreated disease, the U.S. Food and Drug Administration (FDA) approved taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC. Learn more about taletrectinib in the U.S. at IBTROZI.com. 

About the TRUST Clinical Program
The TRUST clinical program comprises three registrational studies evaluating the safety and efficacy of IBTROZI. TRUST-I (NCT04395677) and TRUST-II (NCT04919811) are Phase 2 single-arm studies evaluating IBTROZI for the treatment of adults with advanced ROS1+ NSCLC in China (N=173) and globally (N=189), respectively. The primary endpoint of both studies is confirmed objective response rate (cORR) as assessed by an independent review committee. TRUST-IV (NCT07154706) is a Phase 3 placebo-controlled study evaluating IBTROZI for the adjuvant treatment of adults with resected early-stage ROS1+ NSCLC. The study will enroll approximately 180 patients in the U.S., Canada, Europe, Japan and China. The primary endpoint is disease-free survival as determined by investigator, and the primary completion date is estimated to be in 2030. Nuvation Bio is also sponsoring TRUST-III (NCT06564324), a confirmatory randomized Phase 3 study evaluating IBTROZI versus crizotinib in 194 patients in China with advanced ROS1+ NSCLC who have not previously received ROS1 TKIs. 

U.S. Indication
IBTROZI is indicated for the treatment of adult patients with locally advanced or metastatic ROS1+ non-small cell lung cancer (NSCLC).

IMPORTANT SAFETY INFORMATION FOR IBTROZI^® (taletrectinib) 

WARNINGS AND PRECAUTIONS

Hepatotoxicity: Hepatotoxicity, including drug-induced liver injury and fatal adverse reactions, can occur. 88% of patients experienced increased AST, including 10% Grade 3/4. 85% of patients experienced increased ALT, including 13% Grade 3/4. Fatal liver events occurred in 0.6% of patients. Median time to first onset of AST or ALT elevation was 15 days (range: 3 days to 20.8 months).

Increased AST or ALT each led to dose interruption in 7% of patients and dose reduction in 5% and 9% of patients, respectively. Permanent discontinuation was caused by increased AST, ALT, or bilirubin each in 0.3% and by hepatotoxicity in 0.6% of patients.

Concurrent elevations in AST or ALT ≥3 times the ULN and total bilirubin ≥2 times the ULN, with normal alkaline phosphatase, occurred in 0.6% of patients.

Interstitial Lung Disease (ILD)/Pneumonitis: Severe, life-threatening, or fatal ILD or pneumonitis can occur. ILD/pneumonitis occurred in 2.3% of patients, including 1.1% Grade 3/4. One fatal ILD case occurred at the 400 mg daily dose. Median time to first onset of ILD/pneumonitis was 3.8 months (range: 12 days to 11.8 months).

ILD/pneumonitis led to dose interruption in 1.1% of patients, dose reduction in 0.6% of patients, and permanent discontinuation in 0.6% of patients.

QTc Interval Prolongation: QTc interval prolongation can occur, which can increase the risk for ventricular tachyarrhythmias (e.g., torsades de pointes) or sudden death. IBTROZI prolongs the QTc interval in a concentration-dependent manner.

In patients who received IBTROZI and underwent at least one post baseline ECG, QTcF increase of >60 msec compared to baseline and QTcF >500 msec occurred in 13% and 2.6% of patients, respectively. 3.4% of patients experienced Grade ≥3. Median time from first dose of IBTROZI to onset of ECG QT prolongation was 22 days (range: 1 day to 38.7 months). Dose interruption and dose reduction each occurred in 2.8% of patients.

Significant QTc interval prolongation may occur when IBTROZI is taken with food, strong and moderate CYP3A inhibitors, and/or drugs with a known potential to prolong QTc. Administer IBTROZI on an empty stomach. Avoid concomitant use with strong and moderate CYP3A inhibitors and/or drugs with a known potential to prolong QTc.

Hyperuricemia: Hyperuricemia can occur and was reported in 14% of patients, with 16% of these requiring urate-lowering medication without pre-existing gout or hyperuricemia. 0.3% of patients experienced Grade ≥3. Median time to first onset was 2.1 months (range: 7 days to 35.8 months). Dose interruption occurred in 0.3% of patients.

Myalgia with Creatine Phosphokinase (CPK) Elevation: Myalgia with or without CPK elevation can occur. Myalgia occurred in 10% of patients. Median time to first onset was 11 days (range: 2 days to 10 months).

Concurrent myalgia with increased CPK within a 7-day time period occurred in 0.9% of patients. Dose interruption occurred in 0.3% of patients with myalgia and concurrent CPK elevation.

Skeletal Fractures: IBTROZI can increase the risk of fractures. ROS1 inhibitors as a class have been associated with skeletal fractures. 3.4% of patients experienced fractures, including 1.4% Grade 3. Some fractures occurred in the setting of a fall or other predisposing factors. Median time to first onset of fracture was 10.7 months (range: 26 days to 29.1 months). Dose interruption occurred in 0.3% of patients.

Embryo-Fetal Toxicity: Based on literature, animal studies, and its mechanism of action, IBTROZI can cause fetal harm when administered to a pregnant woman.

ADVERSE REACTIONS
Among patients who received IBTROZI, the most frequently reported adverse reactions (≥20%) were diarrhea (64%), nausea (47%), vomiting (43%), dizziness (22%), rash (22%), constipation (21%), and fatigue (20%).

The most frequently reported Grade 3/4 laboratory abnormalities (≥5%) were increased ALT (13%), increased AST (10%), decreased neutrophils (5%), and increased creatine phosphokinase (5%).

DRUG INTERACTIONS

• Strong and Moderate CYP3A Inhibitors/CYP3A Inducers and Drugs that Prolong the QTc Interval: Avoid concomitant use.
• Gastric Acid Reducing Agents: Avoid concomitant use with PPIs and H2 receptor antagonists. If an acid-reducing agent cannot be avoided, administer locally acting antacids at least 2 hours before or 2 hours after taking IBTROZI.

OTHER CONSIDERATIONS

• Pregnancy: Please see important information in Warnings and Precautions under Embryo-Fetal Toxicity.
• Lactation: Advise women not to breastfeed during treatment and for 3 weeks after the last dose.
• Effect on Fertility: Based on findings in animals, IBTROZI may impair fertility in males and females. The effects on animal fertility were reversible.
• Pediatric Use: The safety and effectiveness of IBTROZI in pediatric patients has not been established.
• Photosensitivity: IBTROZI can cause photosensitivity. Advise patients to minimize sun exposure and to use sun protection, including broad-spectrum sunscreen, during treatment and for at least 5 days after discontinuation.

Please see accompanying full Prescribing Information.

About Nuvation Bio
Nuvation Bio is a global oncology company focused on tackling some of the toughest challenges in cancer treatment with the goal of developing therapies that create a profound, positive impact on patients' lives. Our diverse pipeline includes taletrectinib (IBTROZI^®), a next-generation ROS1 inhibitor; safusidenib, a brain-penetrant IDH1 inhibitor; and an innovative drug-drug conjugate (DDC) program. 

Nuvation Bio was founded in 2018 by biopharma industry veteran David Hung, M.D., who previously founded Medivation, Inc., which brought to patients one of the world's leading prostate cancer medicines. Nuvation Bio has offices in New York, San Francisco, Boston, and Shanghai. For more information, visit www.nuvationbio.com or follow the company on LinkedIn and X (@nuvationbioinc). 

Forward-Looking Statements
Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accompanied by words such as "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "expect," "should," "would," "plan," "predict," "potential," "seem," "seek," "future," "outlook" and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding IBTROZI'S therapeutic potential, as well as EMA and MHRA regulatory review timelines and potential outcomes. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the management team of Nuvation Bio and are not predictions of actual performance. These forward-looking statements are subject to a number of risks and uncertainties that may cause actual results to differ from those anticipated by the forward-looking statements, including but not limited to the challenges associated with conducting drug discovery and commercialization, and initiating or conducting clinical studies due to, among other things, difficulties or delays in the regulatory process, enrolling subjects or manufacturing or acquiring necessary products; the emergence or worsening of adverse events or other undesirable side effects; risks associated with preliminary and interim data, which may not be representative of more mature data; physician and patient behavior; and competitive developments. Risks and uncertainties facing Nuvation Bio are described more fully in its Form 10-Q filed with the SEC on August 6, 2026 under the heading "Risk Factors," and other documents that Nuvation Bio has filed or will file with the SEC. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this press release. Nuvation Bio disclaims any obligation or undertaking to update, supplement or revise any forward-looking statements contained in this press release.

Media and Investor Contacts

Nuvation Bio Investor Contact
JR DeVita
ir@nuvationbio.com

Nuvation Bio Media Contact
Kaitlyn Nealy
media@nuvationbio.com

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SOURCE Nuvation Bio Inc.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What new clinical data supported the supplemental NDA approval for IBTROZI?

The approval incorporates an additional 14 months of data from the pivotal Phase 2 TRUST‑I (China, N=173) and TRUST‑II (global, N=189) studies, with a median follow‑up of 51 months in TRUST‑I. Many patients remained on therapy for extended periods with continued responses, some for multiple years, demonstrating long‑term durability and tolerability.

For which patients is IBTROZI currently indicated in the United States?

IBTROZI is indicated in the U.S. for the treatment of adult patients with locally advanced or metastatic ROS1‑positive non‑small cell lung cancer (NSCLC). The June 2025 full approval covers use across lines of therapy in this population.

What ongoing clinical trials are further evaluating IBTROZI?

The TRUST program includes: TRUST‑I (NCT04395677) and TRUST‑II (NCT04919811), Phase 2 single‑arm studies in advanced ROS1+ NSCLC in China and globally, respectively, both with confirmed objective response rate as the primary endpoint; TRUST‑IV (NCT07154706), a Phase 3 placebo‑controlled adjuvant study in approximately 180 patients with resected early‑stage ROS1+ NSCLC, with disease‑free survival as the primary endpoint and primary completion estimated in 2030; and TRUST‑III (NCT06564324), a confirmatory randomized Phase 3 study of IBTROZI versus crizotinib in 194 patients in China with advanced ROS1+ NSCLC who are ROS1 TKI‑naïve.

In which regions outside the U.S. is taletrectinib already approved or under review?

Taletrectinib (IBTROZI) is approved for advanced ROS1+ NSCLC in Japan, where it is marketed by Nippon Kayaku, and in China, where Innovent Biologics markets it as DOVBLERON. A Marketing Authorisation Application was validated by the European Medicines Agency in March 2026 and by the UK MHRA in June 2026 for full approval consideration under standard review timelines.

What key safety monitoring considerations are highlighted for IBTROZI?

The label highlights risks of hepatotoxicity (including drug‑induced liver injury and rare fatal events), interstitial lung disease/pneumonitis, QTc interval prolongation, hyperuricemia, myalgia with CPK elevation, skeletal fractures, and embryo‑fetal toxicity. Recommendations include monitoring liver function tests, pulmonary symptoms, ECGs for QTc changes, uric acid and CPK when indicated, and advising on fracture risk, contraception, and pregnancy avoidance.

How should IBTROZI be taken and what drug interactions are emphasized?

IBTROZI should be administered on an empty stomach. Concomitant use with strong or moderate CYP3A inhibitors or inducers and with drugs that prolong the QTc interval should be avoided. Use with proton pump inhibitors and H2 receptor antagonists should also be avoided; if acid‑reducing therapy cannot be avoided, locally acting antacids should be taken at least 2 hours before or 2 hours after IBTROZI.

What special patient populations or lifestyle precautions are mentioned for IBTROZI?

The safety and effectiveness of IBTROZI in pediatric patients have not been established. Women are advised not to breastfeed during treatment and for 3 weeks after the last dose. Based on animal data, IBTROZI may impair male and female fertility, though effects were reversible. The drug can cause photosensitivity, and patients are advised to minimize sun exposure and use sun protection, including broad‑spectrum sunscreen, during treatment and for at least 5 days after discontinuation.