Latest news with #taletrectinib
WebMD
12-06-2025
- Health
- WebMD
FDA OKs New Next-Gen Pill for Rare Lung Cancer
approved a first-of-its-kind oral pill to treat a rare type of advanced lung cancer that often spreads to the brain. The new drug, known as taletrectinib but sold as Ibtrozi, is meant for adults with non-small-cell lung cancer (NSCLC) that has spread or worsened and is linked to a faulty ROS1 gene. This targeted therapy offers new hope to about 3,000 people in the U.S. and over 1 million globally who are diagnosed each year with advanced ROS1-positive NSCLC. NSCLC is the most common form of lung cancer – a leading cause of cancer-related deaths. About 2% of advanced cases are ROS1-positive, which grow faster and are harder to treat. Most patients are diagnosed in their 50s, often without a history of smoking. The cancer often spreads to the brain, seen in 35% at diagnosis and nearly 50% after treatment. This makes treatment especially challenging and highlights the need for better options. The FDA's decision was based on two clinical studies of people with ROS1-positive NSCLC. One trial involved 113 people who had previously been treated with a drug similar to Ibtrozi, while the other included 157 who had not. About 85% to 90% of those new to treatment responded to Ibtrozi, and at least 63% continued to see benefits for over a year. Among those previously treated, about 52% to 62% improved, with most (up to 83%) continuing to respond for at least six months. Ibtrozi also helped shrink brain tumors in 73% of people who were new to similar treatments, and in 63% of those who had tried one before, according to a news release by Nuvation Bio, the drug's maker. "Ibtrozi's durability of response and ability to effectively penetrate the brain, coupled with a well-characterized and manageable safety profile, further addresses these critical needs for patients," said Nathan Pennell, MD, PhD, a professor of medicine at the Cleveland Clinic and an investigator of the clinical trials. Ibtrozi belongs to a class of medicines called tyrosine kinase inhibitors (TKIs). It blocks the faulty ROS1 protein, helping slow cancer growth and spread. Ibtrozi is designed to reach the brain and keep the disease under control for longer. The FDA recommends 600 mg oral Ibtrozi pills once a day on an empty stomach, with no food two hours before or after taking it. Treatment continues until the cancer worsens or side effects become too serious. The most common side effects include things like nausea, diarrhea, tiredness, and dizziness. The FDA also warns about more serious risks, like liver and lung problems, heart rhythm issues, muscle pain, and possible harm to an unborn baby. People who use the drug should tell their doctor about all medications they're taking, including over-the-counter ones – especially anything for acid reflux. Women are advised not to breastfeed during treatment and for three weeks afterward. It's also important to protect your skin from the sun while taking the drug and for at least five days after stopping it.
Medscape
11-06-2025
- 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
11-06-2025
- 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.
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
