Drugs / AB-106
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | RET fusion positive cancer | 2024-12-20 | “Based on pooled results of the TRUST-I and TRUST-II clinical studies, Nuvation Bio Inc. (NYSE: NUVB) submitted an NDA for taletrectinib to the U.S. FDA” innoventbio.com ↗ |
Trials 9
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT05609929 | Nov 2022 → Jan 2023 | — | Nuvation Bio Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05357820 | Jul → Dec 2021 | cancer | Nuvation Bio Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05357911 | Jul → Aug 2021 | cancer | Nuvation Bio Inc. | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT06214793 | Oct 2026 → Jan 2030 | breast cancer | Megan Kruse, MD | Suspended | No outcome recorded |
| Phase 2 | NCT04919811 | Sep 2021 → Jun 2025 overdue | non-small cell lung carcinoma | Nuvation Bio Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04617054 | Jun 2021 → Dec 2024 | neoplasm | Nuvation Bio Inc. | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT04395677 | Jul 2020 → Jun 2024 overdue | non-small cell lung carcinoma | Nuvation Bio Inc. | Active not recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT06564324 | Nov 2024 → Jan 2029 expected | non-small cell lung carcinoma | Nuvation Bio Inc. | Recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT06841874 | — | bronchogenic carcinoma, non-small cell lung carcinoma | Nuvation Bio Inc. | No longer available | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 3 | NCT07154706 Comparator | Aug 2025 → Aug 2030 expected | non-small cell lung carcinoma | Nuvation Bio Inc. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 34
| Date | Issuer | Release |
|---|---|---|
| 2026-09-17 | Nuvation Bio Inc. | Regulatory 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 nuvationbio.com ↗
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). |
| 2026-09-15 | Nuvation Bio Inc. | Results Nuvation Bio Announces New Analyses Reinforcing the Durable, Consistent Efficacy of IBTROZI® (taletrectinib) Across Key Patient Subgroups in Advanced ROS1+ NSCLC at 2026 World Conference on Lung Cancer nuvationbio.com ↗
These analyses offer reassurance that patients who do start chemotherapy before a ROS1 fusion is identified can still respond well once they transition to taletrectinib. |
| 2026-06-29 | Nuvation Bio Inc. | Regulatory Nuvation Bio Announces Marketing Authorisation Application for Taletrectinib for the Treatment of Advanced ROS1-Positive Non-Small Cell Lung Cancer Validated in the United Kingdom nuvationbio.com ↗ |
| 2026-06-26 | Eisai Inc. | Regulatory Marketing Authorisation Application for Taletrectinib for the Treatment of Advanced ROS1-Positive Non-Small Cell Lung Cancer Validated in the United Kingdom A Marketing Authorisation Application with the European Medicines Agency is also under regulatory review for approval eisai.com ↗
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom has validated the Marketing Authorisation Application (MAA) for taletrectinib for the treatment of advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC). |
| 2026-05-27 | Nuvation Bio Inc. | Results Nuvation Bio to Present New Quality-of-Life Data for IBTROZI® (Taletrectinib) in Patients with ROS1-Positive Non-Small Cell Lung Cancer at ASCO 2026 Annual Meeting nuvationbio.com ↗
88% of TRUST-II patients reported improved or stable quality of life at first assessment, with the majority sustaining that benefit throughout treatment |
| 2026-05-06 | Nuvation Bio Inc. | Regulatory 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 nuvationbio.com ↗ |
| 2026-05-04 | Nuvation Bio Inc. | Results Nuvation Bio Reports First Quarter 2026 Financial Results and Provides Business Update nuvationbio.com ↗
For TKI-naïve patients (n=157): the analysis showed a cORR of 89.8%, a mDOR of 49.7 months, a mPFS of 46.1 months and an intracranial response rate of 76.5% in patients with brain metastases (n=17). |
| 2026-04-21 | Nuvation Bio Inc. | Results Nuvation Bio Announces IBTROZI® (Taletrectinib) Showed Highly Durable Responses in Longer-Term Follow-up Data from Pivotal Studies Presented at AACR 2026 nuvationbio.com ↗
The long-term pooled results in TKI-naïve patients demonstrated a confirmed objective response rate (cORR) of 89.8%, a median duration of response (mDOR) of 49.7 months and a median progression-free survival (mPFS) of 46.1 months. |
| 2026-03-27 | Eisai Inc. | Regulatory Eisai and Nuvation Bio Announce Marketing Authorisation Application for Taletrectinib for the Treatment of Advanced ROS1-Positive Non-Small Cell Lung Cancer Validated by the European Medicines Agency The Marketing Authorisation Application (MAA) has been validated and accepted for full approval consideration with a standard review timeline Additional filings are planned for the U.K., Canada and other regions included in Eisai’s licensed territories Taletrectinib is already approved in the U.S., China and Japan for advanced ROS1-positive non-small cell lung cancer eisai.com ↗
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”), a human-centered global leading research-based pharmaceutical company working in the neurology and oncology therapeutic areas, and Nuvation Bio Inc. (NYSE: NUVB, Corporate Headquarters: New York, NY, CEO: David Hung, M.D., “Nuvation Bio”), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced that the European Medicines Agency (EMA) has validated the Marketing Authorisation Application (MAA) for taletrectinib for the treatment of advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC). |
| 2026-03-26 | Nuvation Bio Inc. | Regulatory Eisai and Nuvation Bio Announce Marketing Authorisation Application for Taletrectinib for the Treatment of Advanced ROS1-Positive Non-Small Cell Lung Cancer Validated by the European Medicines Agency nuvationbio.com ↗ |
| 2026-03-17 | Nuvation Bio Inc. | Results Nuvation Bio to Present Pivotal IBTROZI® (Taletrectinib) Data in TKI-Naïve and TKI-Pretreated Patients with Advanced ROS1-Positive Non-Small Cell Lung Cancer at AACR 2026 nuvationbio.com ↗
Clinical data demonstrate IBTROZI's unprecedented durability in TKI-naïve advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC), with median Duration of Response (DOR) now increased to 50 months as of August 2025 data cutoff |
| 2025-11-03 | Nuvation Bio Inc. | Results Nuvation Bio Reports Third Quarter 2025 Financial Results and Provides Business Update nuvationbio.com ↗
We are also pleased to share that IBTROZI’s robust durability profile continues to mature and now shows a 50-month median duration of response as of the latest August data cut-off. |
| 2025-09-19 | Nuvation Bio Inc. | Regulatory Nuvation Bio Receives Approval from Japan’s Ministry of Health, Labour and Welfare for IBTROZI™ for Patients with Advanced ROS1-positive Non-Small Cell Lung Cancer nuvationbio.com ↗
Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved IBTROZI™ (taletrectinib) for the treatment of adult patients with ROS1-positive (ROS1+) unresectable, advanced and/or recurrent non-small cell lung cancer (NSCLC). |
| 2025-09-07 | Nuvation Bio Inc. | Results Nuvation Bio Announces New Data from Pivotal Clinical Studies of IBTROZI™ (taletrectinib) in Advanced ROS1-Positive Non-Small Cell Lung Cancer at 2025 World Conference on Lung Cancer nuvationbio.com ↗
TKI-naïve patients in TRUST-I achieved a median progression-free survival of 44.6 months; more than half of TKI-naïve patients in TRUST-II were still progression-free at data cut-off |
| 2025-06-11 | Nuvation Bio Inc. | Regulatory U.S. Food and Drug Administration Approves Nuvation Bio’s IBTROZI™ (taletrectinib), a Next-Generation Oral Treatment for Advanced ROS1-Positive Non-Small Cell Lung Cancer nuvationbio.com ↗
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 IBTROZI™ (taletrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC). |
| 2025-06-02 | Nippon Kayaku Co., Ltd. | Results 新規ROS1 阻害剤 TaletrectinibのROS1融合遺伝子陽性の進行性非小細胞肺癌を対象とした2つの第II相試験の部分集団解析の発表（ASCO 2025）について nipponkayaku.co.jp ↗
部分集団解析の結果、主要な安全性、有効性プロファイルは2つの試験間で一貫しており、併合集団においても人種、及び地域間で一貫性が認められました。 |
| 2025-04-22 | Nuvation Bio Inc. | Regulatory Nuvation Bio to Report Results for First Quarter 2025 and Provide Business Update on May 7, 2025 nuvationbio.com ↗
The U.S. Food and Drug Administration assigned taletrectinib’s New Drug Application with a Prescription Drug User Fee Act goal date of June 23, 2025. |
| 2025-03-03 | Nippon Kayaku Co., Ltd. | Regulatory 新規ROS1阻害剤 TaletrectinibのROS1融合遺伝子陽性の切除不能な進行・再発の非小細胞肺癌に係る製造販売承認申請について nipponkayaku.co.jp ↗
日本化薬株式会社（本社:東京、代表取締役社長：涌元厚宏、以下「日本化薬」）は、Nuvation Bio Inc.（本社：米国ニューヨーク、CEO：David Hung, M.D.以下 「ニュベーション社」）より導入しましたTaletrectinib（開発コード：AB-106／DS-6051b、以下、「本剤」）について、製造販売承認申請を行いましたのでお知らせいたします。 |
| 2025-01-06 | Nuvation Bio Inc. | Regulatory Nuvation Bio Receives Approval from China’s National Medical Products Administration for Taletrectinib for Patients with Advanced ROS1-positive Non-Small Cell Lung Cancer nuvationbio.com ↗ |
| 2025-01-03 | Innovent Biologics (Suzhou) Co. Ltd. | Regulatory Innovent Announces Second New Drug Application of DOVBLERON ® (Taletrectinib Adipate Capsule, ROS1 Inhibitor) was Approved by China’s National Medical Products Administration innoventbio.com ↗ |
| 2024-12-23 | Nuvation Bio Inc. | Regulatory U.S. Food and Drug Administration Accepts for Priority Review Nuvation Bio’s New Drug Application for Taletrectinib for the Treatment of Advanced ROS1-positive Non-Small Cell Lung Cancer nuvationbio.com ↗
The U.S. FDA has granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 23, 2025. |
| 2024-12-20 | Innovent Biologics (Suzhou) Co. Ltd. | Regulatory Innovent Receives Approval of DOVBLERON ® (Taletrectinib Adipate Capsule, ROS1 Inhibitor) by China’s National Medical Products Administration innoventbio.com ↗
The approval of DOVBLERON® provides a new and effective treatment option for patients who are no longer responding to previously approved therapies. |
| 2024-11-01 | Nippon Kayaku Co., Ltd. | Results 新規ROS1阻害剤 TaletrectinibのROS1融合遺伝子陽性の進行性非小細胞肺癌を対象としたグローバル第II相臨床試験結果の発表について nipponkayaku.co.jp ↗
この結果は全体集団で確認された、本剤の良好な有効性および安全性プロファイルが日本人集団においても確認されたことを示すものでした。 |
| 2024-09-14 | Nuvation Bio Inc. | Results Positive Pooled Data from Nuvation Bio’s TRUST-I and TRUST-II Studies Highlight Taletrectinib’s Best-in-Class Potential for Patients with Advanced ROS1-positive NSCLC, Supporting Planned New Drug Application Submission in the Fourth Quarter of 2024 nuvationbio.com ↗
Nuvation Bio Inc. (NYSE: NUVB), a late clinical-stage, global biopharmaceutical company tackling some of the greatest unmet needs in oncology, today announced positive pooled data from the pivotal Phase 2 TRUST-I and TRUST-II studies evaluating taletrectinib, an investigational next-generation ROS1 TKI. |
| 2024-07-23 | Nuvation Bio Inc. | Regulatory Nuvation Bio Announces Updates and Upcoming Presentations for its ROS1 Inhibitor, Taletrectinib nuvationbio.com ↗
Additionally, the U.S. FDA has granted Orphan Drug Designation to taletrectinib for the treatment of multiple NSCLC indications, including ROS1-positive NSCLC. |
| 2024-06-02 | Innovent Biologics (Suzhou) Co. Ltd. | Results Innovent Announces Taletrectinib（ROS1 Inhibitor）Updated Data from Pivotal Phase 2 TRUST-I Study of are Published in the JCO and Orally Presentedat 2024 ASCO Annual Meeting innoventbio.com ↗
Data were reported from 173 patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) who were treated with taletrectinib. |
| 2024-06-01 | Nuvation Bio Inc. | Results Nuvation Bio Announces Data from Pivotal Phase 2 TRUST-I Study of its Investigational ROS1 Inhibitor, Taletrectinib, are Published in the Journal of Clinical Oncology and Reported at 2024 ASCO Annual Meeting nuvationbio.com ↗
Responses were durable with long-term follow-up; 71% of TKI-naïve patients were still progression-free at two years |
| 2024-03-05 | Innovent Biologics (Suzhou) Co. Ltd. | Regulatory Innovent and AnHeart Therapeutics Announce the NMPA of China Has Accepted Second NDA for Taletrectinib for First-Line Treatment of ROS1-Positive Lung Cancer innoventbio.com ↗ |
| 2023-12-19 | Innovent Biologics (Suzhou) Co. Ltd. | Regulatory Innovent and AnHeart Therapeutics Announce the National Medical Products Administration of China Has Granted Taletrectinib (ROS1 Inhibitor) Priority Review Designation innoventbio.com ↗ |
| 2023-11-23 | Innovent Biologics (Suzhou) Co. Ltd. | Regulatory Innovent and AnHeart Therapeutics Announce the National Medical Products Administration of China Has Accepted the New Drug Application for Taletrectinib (ROS1 Inhibitor) innoventbio.com ↗
the New Drug Application (NDA) for taletrectinib, a next-generation ROS1 tyrosine kinase inhibitor (TKI), has been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China |
| 2022-06-07 | Innovent Biologics (Suzhou) Co. Ltd. | Results Innovent and AnHeart Jointly Present Updated Phase 2 Efficacy and Safety Data of Taletrectinib (ROS1-TKI) at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting innoventbio.com ↗
In 67 ROS1 TKI-naïve patients, the confirmed objective response rate (cORR) and disease control rate (DCR) were 92.5% and 95.5%, respectively. |
| 2022-03-01 | Innovent Biologics (Suzhou) Co. Ltd. | Regulatory Innovent Biologics and AnHeart Therapeutics Receive NMPA Breakthrough Designation for Taletrectinib in ROS1-Positive Non-Small Cell Lung Cancer innoventbio.com ↗ |
| 2021-09-27 | Innovent Biologics (Suzhou) Co. Ltd. | Results Innovent and AnHeart Announce Interim Data from Phase 2 Trial (TRUST Study) of Taletrectinib in ROS1-Positive NSCLC at the CSCO 2021 Annual Meeting innoventbio.com ↗
Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, and AnHeart Therapeutics Co., Ltd (“AnHeart”), a clinical-stage biopharmaceutical company committed to developing novel first-in-class or best-in-class precision oncology therapeutics, today jointly announced the interim clinical data from a Phase 2 trial (TRUST) evaluating taletrectinib (AB-106), an investigational next-generation ROS1/NTRK inhibitor in ROS1-positive non-small cell lung cancer (NSCLC). |
| 2021-06-07 | Innovent Biologics (Suzhou) Co. Ltd. | Results Innovent and AnHeart Release Preliminary Results from the Phase II TRUST Trial of Taletrectinib in ROS1 Fusion Positive NSCLC at the ASCO 2021 Annual Meeting innoventbio.com ↗
In the crizotinib treatment-naïve patients (n=15), the overall response rate (ORR) was 93% (14/15) and the disease control rate (DCR) was 93% (14/15); |
All press releases naming this drug 49 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 12 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | AB-106 | “Former Name(s) or Alias(es): AB-106.” NCT07154706 ↗ |
| Known as | DS-6051b | “Taletrectinib (AB-106/DS-6051b) is a potent, highly selective, orally bioavailable ROS1 and TRK family inhibitor” NCT06214793 ↗ |
| Known as | Taletrectinib | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04919811 ↗ |
| Action | Inhibit | “ROS1 tyrosine kinase inhibitor (TKI)” PMID 42013573 ↗ Apr 2026 |
| Modality | Small molecule | “ROS1 tyrosine kinase inhibitor (TKI)” PMID 42013573 ↗ Apr 2026 |
| Route | Oral | “once-daily oral taletrectinib 600 mg” PMID 40179330 ↗ Apr 2025 |
| Target | ROS1 | “ROS1 tyrosine kinase inhibitor (TKI)” PMID 42013573 ↗ Apr 2026 |