Latest news with #NuvationBio
Medscape
4 hours ago
- Business
- Medscape
Taletrectinib Approved for NSCLC
The FDA has approved taletrectinib (Ibtrozi, Nuvation Bio) for locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) in first- and later-line settings, regardless of prior ROS1 tyrosine kinase inhibitor (TKI) exposure. Taletrectinib is considered a next-generation ROS1 TKI to distinguish it from two first-generation products already on the US market: crizotinib and entrectinib. A third ROS1 TKI approved in 2023, repotrectinib, is also a next-generation medicine. Like repotrectinib, FDA granted taletrectinib a breakthrough therapy designation. Compared with crizotinib and entrectinib, Nuvation Bio data suggests taletrectinib has greater brain penetration, lower incidence of neurologic adverse events, less likelihood of resistance, and other benefits, plus a possible safety and efficacy edge over next-generation rival repotrectinib. 'Taletrectinib will likely become the preferred treatment option for advanced ROS1+ NSCLC,' commented Thomas E. Stinchcombe, MD, an associate editor at the Journal of Clinical Oncology , in the 'Context' section of his journal's publication of a pooled analysis of Nuvation Bio's two approval studies, TRUST-I and TRUST-II, in April. Taletrectinib was originally developed in China and was approved there in Jan 2025 for the same indication granted by FDA. The company plans a US launch in mid-2025, they stated in a press release. About 2% of NSCLC patients have ROS1-positive disease, and about a third of them present with brain metastases. ROS1-positive patients have an oncogenic rearrangement in the ROS1 gene, which leads to an abnormal ROS1 fusion protein that drives cancer growth. ROS1 TKIs block the protein's activity. The drug's approval was based on results of TRUST-I and TRUST-II, phase 2, single-arm, open label studies in ROS1-positive NSCLC patients treated with oral taletrectinib 600 mg once daily until progression, unacceptable toxicity, death, or consent withdrawal. Of the 273 subjects in the pooled analysis, 93.8% had stage IV disease, 33.7% had brain metastases, and 27.1% had received chemotherapy. TRUST-I included Chinese subjects who were either new to TKIs or who had received crizotinib. TRUST-II included patients from North America, Europe, and Asia who were TKI-naive or who had been treated with crizotinib or entrectinib. The efficacy population included 157 patients (103 in TRUST-I; 54 in TRUST-II) who were naive to treatment with a ROS1 TKI and 113 patients (66 in TRUST-I; 47 in TRUST-II) who had received one prior ROS1 TKI. Patients may have received prior chemotherapy for advanced disease. For treatment-naive patients, the overall response rate (ORR) was 90% in TRUST-I and 85% in TRUST-II, with 72% and 63% of responders having a duration of response (DOR) of at least a year, respectively. For TKI-pretreated patients, ORR was 52% in TRUST-I and 62% in TRUST-II, with 74% and 83% of responders having a DOR of at least 6 months, respectively. Among 13 patients with a G2032R mutation, which triggers resistance to first generation ROS1 TKIs, eight (61.5%) had a response to taletrectinib. In a safety analysis with 352 patients, the most frequent treatment-emergent adverse events with taletrectinib were gastrointestinal problems (88%) and elevated aspartate aminotransferase (72%) and alanine aminotransferase (68%). Neurologic adverse events included dizziness (21%) and dysgeusia (15%). Overall, 33% of patients had grade 3 or higher treatment-related adverse events. Treatment-emergent adverse events led to discontinuation in 7% of patients. There were three treatment-related deaths due to abnormal hepatic function, liver failure, and pneumonia. Prescribing information for taletrectinib includes warnings and precautions for hepatotoxicity, interstitial lung disease/pneumonitis, QTc interval prolongation, hyperuricemia, myalgia with creatine phosphokinase elevation, skeletal fractures, and embryo-fetal toxicity. The recommended taletrectinib dose is 600 mg orally once daily on an empty stomach until disease progression or unacceptable toxicity. Taletrectinib pricing was not available, but fourteen 160 mg capsules of rival repotrectinib — the initial 2-week supply with daily dosages doubling afterwards — is $7,666.97, according to
Reuters
7 hours ago
- Health
- Reuters
US FDA approves Nuvation Bio's lung cancer therapy
June 11 (Reuters) - The U.S. Food and Drug Administration said on Wednesday it has approved Nuvation Bio's (NUVB.N), opens new tab therapy for patients with a type of lung cancer. The once-daily oral drug, with brand name Ibtrozi, is approved to treat ROS1-positive non-small cell lung cancer (NSCLC). NSCLC affects more than one million people globally, with about 2% having ROS1-positive disease, according to the company. The drug, taletrectinib, belongs to a class of drugs known as ROS1 inhibitors.
Business Wire
21-05-2025
- Business
- Business Wire
Nuvation Bio To Present New Data from Pivotal Clinical Studies of Taletrectinib in Advanced ROS1-Positive Non-Small Cell Lung Cancer at ASCO 2025 Annual Meeting
NEW YORK--(BUSINESS WIRE)--Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced that additional results from TRUST-I and TRUST-II, its pivotal Phase 2 clinical studies on the efficacy and safety of taletrectinib for the treatment of advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC), will be presented at the upcoming American Society of Clinical Oncology (ASCO) 2025 Annual Meeting taking place May 30–June 3, 2025, in Chicago, Illinois. 'Taletrectinib is a highly selective, next-generation oral tyrosine kinase inhibitor, with the potential to expand what's possible for patients with ROS1-positive non-small cell lung cancer,' saidDavid Hung, M.D., Founder, President and Chief Executive Officer of Nuvation Bio. 'We look forward to presenting data from our pivotal TRUST-I and TRUST-II clinical studies, which further demonstrate the potential efficacy and safety of taletrectinib in patients across ethnicities and regions of the world. With a PDUFA date and potential approval by the U.S. FDA in just over a month, we are looking forward to hopefully bringing a truly meaningful new option to patients living with this disease.' Presentation Overview: Title: Presenter: Maurice Perol, Department of Medical Oncology, Léon Bérard Cancer Center, Lyon, France Date: Session Time: 1:30-4:30 p.m. CT Abstract Number: #8643 Location: Poster #123 The materials will be made available in the Publications section of Nuvation Bio's website after the session. To learn more about Nuvation Bio, visit Booth #28031 at the ASCO Annual Meeting. About Taletrectinib Taletrectinib is an oral, potent, central nervous system-active, selective, next-generation ROS1 inhibitor specifically designed for the treatment of patients with advanced ROS1+ NSCLC. Taletrectinib is being evaluated for the treatment of patients with advanced ROS1+ NSCLC in two Phase 2 single-arm pivotal studies: TRUST-I (NCT04395677) in China, and TRUST-II (NCT04919811), a global study. Based on results of the TRUST-I and TRUST-II clinical studies, the U.S. FDA has accepted and granted Priority Review to Nuvation Bio's NDA for taletrectinib for advanced ROS1+ NSCLC (line agnostic, full approval) and assigned a PDUFA goal date of June 23, 2025. The U.S. FDA previously granted taletrectinib Breakthrough Therapy Designation for the treatment of patients with locally advanced or metastatic ROS1+ NSCLC who either have or have not previously been treated with ROS1 TKIs, and Orphan Drug Designation for the treatment of patients with ROS1+ NSCLC and other NSCLC indications. In January 2025, China's NMPA approved taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC. About Nuvation Bio Nuvation Bio is a global oncology company focused on tackling some of the toughest challenges in cancer treatment by developing therapies that create a profound, positive impact on patients' lives. Our diverse pipeline includes taletrectinib, a next-generation ROS1 inhibitor; safusidenib, a brain-penetrant IDH1 inhibitor; NUV-1511, an innovative drug-drug conjugate (DDC) designed for targeted cancer treatment; and NUV-868, a BD2-selective BET inhibitor. 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 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, our expectations regarding U.S. FDA approval and timing thereof, and taletrectinib's therapeutic potential in advanced ROS1+ NSCLC. 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 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; and competitive developments. Risks and uncertainties facing Nuvation Bio are described more fully in its Form 10-Q filed with the SEC on May 7, 2025 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.
National Post
13-05-2025
- Business
- National Post
Nuvation Bio to Present Matching-adjusted Indirect Comparison Data for Taletrectinib vs. Entrectinib at ISPOR 2025
Article content NEW YORK — Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced that new data from a matching-adjusted indirect comparison study evaluating taletrectinib versus entrectinib in ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) will be presented in a poster session at ISPOR 2025, the Professional Society for Health Economics and Outcomes Research's annual conference, taking place May 13-16, 2025 in Montreal, QC, Canada. Article content Article content Presentation Overview: Article content Title: Taletrectinib vs Entrectinib in ROS1-Positive (ROS1+) Non-Small Cell Lung Cancer (NSCLC): A Matching-Adjusted Indirect Comparison (MAIC) Presenter: Misako Nagasaka, M.D., Ph.D., Associate Professor – Division of Hematology and Oncology, UCI School of Medicine Date: Wednesday, May 14 Session Time: 10:30 a.m. – 1:30 p.m. ET Session: Poster Session 1 Presentation Number: CO151 Article content The materials will be made available in the Publications section of Nuvation Bio's website after the presentation. Article content About Taletrectinib Article content Taletrectinib is an oral, potent, central nervous system-active, selective, next-generation ROS1 inhibitor specifically designed for the treatment of patients with advanced ROS1+ NSCLC. Taletrectinib is being evaluated for the treatment of patients with advanced ROS1+ NSCLC in two Phase 2 single-arm pivotal studies: TRUST-I (NCT04395677) in China, and TRUST-II (NCT04919811), a global study. Article content Based on results of the TRUST-I and TRUST-II clinical studies, the U.S. FDA has accepted and granted Priority Review to Nuvation Bio's NDA for taletrectinib for advanced ROS1+ NSCLC (line agnostic, full approval) and assigned a PDUFA goal date of June 23, 2025. The U.S. FDA previously granted taletrectinib Breakthrough Therapy Designation for the treatment of patients with locally advanced or metastatic ROS1+ NSCLC who either have or have not previously been treated with ROS1 TKIs, and Orphan Drug Designation for the treatment of patients with ROS1+ NSCLC and other NSCLC indications. In January 2025, China's NMPA approved taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC. Article content About Nuvation Bio Article content Nuvation Bio is a global oncology company focused on tackling some of the toughest challenges in cancer treatment by developing therapies that create a profound, positive impact on patients' lives. Our diverse pipeline includes taletrectinib, a next-generation ROS1 inhibitor; safusidenib, a brain-penetrant IDH1 inhibitor for glioma; NUV-1511, an innovative drug-drug conjugate (DDC) designed for targeted cancer treatment; and NUV-868, a BD2-selective BET inhibitor. Article content 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 or follow the company on LinkedIn and X (@nuvationbioinc). Article content Article content Article content Contacts Article content Article content
Yahoo
12-05-2025
- Business
- Yahoo
Nuvation Bio to Participate in Upcoming Investor Conferences
NEW YORK, May 12, 2025--(BUSINESS WIRE)--Nuvation Bio Inc. (NYSE: NUVB), a global oncology company tackling some of the toughest challenges in cancer treatment, today announced that David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio, and Philippe Sauvage, Chief Financial Officer of Nuvation Bio, will participate in fireside chats at three upcoming investor conferences: H.C. Wainwright 3rd Annual BioConnect Investor Conference at NASDAQ on Tuesday, May 20, 2025, at 3:00 p.m. ET in New York, NY 2025 RBC Capital Markets Global Healthcare Conference on Wednesday, May 21, 2025, at 1:35 p.m. ET in New York, NY TD Cowen 6th Annual Oncology Innovation Summit: Insights for ASCO & EHA on Wednesday, May 28, 2025, at 3:30 p.m. ET (virtual) Live webcasts of each presentation will be available on the Nuvation Bio website at An archived recording will be available for 90 days following each event. About Nuvation Bio Nuvation Bio is a global oncology company focused on tackling some of the toughest challenges in cancer treatment by developing therapies that create a profound, positive impact on patients' lives. Our diverse pipeline includes taletrectinib, a next-generation ROS1 inhibitor; safusidenib, a brain-penetrant IDH1 inhibitor; NUV-1511, an innovative drug-drug conjugate (DDC) designed for targeted cancer treatment; and NUV-868, a BD2-selective BET inhibitor. 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 or follow the company on LinkedIn and X (@nuvationbioinc). View source version on Contacts Nuvation Bio Investor Contact: ir@ Nuvation Bio Media Contact: media@ Error while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
