Approval granted by Japan's Ministry of Health, Labour and Welfare for Nuvation Bio's IBTROZITM in patients with advanced ROS1-positive Non-Small Cell Lung Cancer.
Nuvation Bio, a global oncology company, has 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).
The approval is based on data from the pivotal Phase 2 TRUST clinical program evaluating taletrectinib in patients globally, including Japan. This includes approximately 2% of patients with NSCLC who have ROS1+ disease, a group that is estimated to number over one million people worldwide each year.
About 35% of these patients have tumors that have spread to their brain, making the brain the most common site of disease progression. IBTROZI, an oral, potent, CNS-active, selective, next-generation ROS1 inhibitor therapy, may offer hope for these patients.
However, it's important to note that IBTROZI can cause fetal harm when administered to a pregnant woman. Pregnant women should avoid taking IBTROZI. Also, women are advised not to breastfeed during treatment and for three weeks after the last dose.
The most frequently reported adverse reactions (≥20%) among patients who received IBTROZI were diarrhea, nausea, vomiting, dizziness, rash, constipation, and fatigue. The most frequently reported Grade 3/4 laboratory abnormalities (≥5%) were increased ALT, increased AST, decreased neutrophils, and increased creatine phosphokinase.
Myalgia with creatine phosphokinase (CPK) elevation can occur. Myalgia occurred in 10% of patients. Hyperuricemia can occur and was reported in 14% of patients, with 16% of these requiring urate-lowering medication without pre-existing gout or hyperuricemia.
Skeletal fractures can occur, and IBTROZI can increase the risk of fractures. Patients are advised to take precautions to avoid falls and fractures. IBTROZI can also cause photosensitivity, so patients are advised to minimize sun exposure and use sun protection, including broad-spectrum sunscreen, during treatment and for at least five days after discontinuation.
Upon the first establishment of the reimbursement price in Japan, Nuvation Bio will receive a USD $25 million milestone payment. In Germany, IBTROZI is marketed by Pfizer and has received approval there. In China, taletrectinib is marketed by Innovent Biologics under the brand name DOVBLERON and was previously approved by China's National Medical Products Administration (NMPA) for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC.
Nippon Kayaku will commercialize IBTROZI in Japan under an exclusive license agreement entered in 2023. Results from a pooled analysis of the TRUST clinical program were published in the Journal of Clinical Oncology in April 2025.
Certain statements in this press release are forward-looking statements, which are subject to a number of risks and uncertainties that may cause actual results to differ from those anticipated. These risks and uncertainties are described more fully in Nuvation Bio's Form 10-Q filed with the SEC on August 7, 2025, under the heading "Risk Factors."
It's important to note that the safety and effectiveness of IBTROZI in pediatric patients have not been established. IBTROZI may impair fertility in males and females. The effects on animal fertility were reversible. Drug interactions should be carefully managed, avoiding concomitant use with strong and moderate CYP3A inhibitors, drugs that prolong the QTc interval, gastric acid reducing agents (PPIs and H2 receptor antagonists), and drugs that can cause photosensitivity.
In conclusion, the approval of IBTROZI in Japan marks a significant step forward in the treatment of ROS1+ NSCLC, offering hope for patients with this aggressive form of lung cancer. However, it's crucial that patients and healthcare providers are aware of the potential risks and side effects associated with IBTROZI, and that appropriate precautions are taken to manage these risks.
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