{"id":962452,"date":"2026-05-13T19:04:48","date_gmt":"2026-05-13T23:04:48","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/nuvation-bio-to-collaborate-with-thermo-fisher-scientific-for-u-s-based-manufacturing-of-ibtrozi-for-ros1-positive-non-small-cell-lung-cancer\/"},"modified":"2026-05-13T19:04:48","modified_gmt":"2026-05-13T23:04:48","slug":"nuvation-bio-to-collaborate-with-thermo-fisher-scientific-for-u-s-based-manufacturing-of-ibtrozi-for-ros1-positive-non-small-cell-lung-cancer","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/nuvation-bio-to-collaborate-with-thermo-fisher-scientific-for-u-s-based-manufacturing-of-ibtrozi-for-ros1-positive-non-small-cell-lung-cancer\/","title":{"rendered":"Nuvation Bio to Collaborate with Thermo Fisher Scientific for U.S.-Based Manufacturing of IBTROZI\u00ae for ROS1-Positive Non-Small Cell Lung Cancer"},"content":{"rendered":"
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PR Newswire<\/p>\n<\/p><\/div>\n

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\n Thermo Fisher Scientific, the world leader in serving science, will now manufacture drug product for Nuvation Bio in the United States<\/i>\n <\/p>\n

\n Move by Nuvation Bio further ensures critical drug supply for patients and providers<\/i>\n <\/p>\n

\n NEW YORK<\/span>, May 13, 2026<\/span> \/PRNewswire\/ — Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced the successful completion of process tech transfer and product introduction to Thermo Fisher Scientific, the world leader in serving science, for IBTROZI\u00ae<\/sup> (taletrectinib) to treat advanced or metastatic ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC). The transition was submitted as a supplement to the IBTROZI New Drug Application held by Nuvation Bio and is now complete.<\/p>\n

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“Our commitment to unencumbered access to IBTROZI for appropriate patients with ROS1+ NSCLC starts at the manufacturing stage, where we work to ensure that our collaborators and processes deliver critical medicine with high quality,” said David Hung, M.D., Founder, President and Chief Executive Officer of Nuvation Bio. “We are pleased to collaborate with Thermo Fisher, a leading contract manufacturer of pharmaceuticals, to bring IBTROZI manufacturing closer to the patients we serve.”<\/p>\n

Jennifer Cannon, President, Commercial Operations, Pharma Services at Thermo Fisher added, “We are pleased that Nuvation Bio has selected us for their final drug product manufacturing of IBTROZI in the United States. Our collaboration with Nuvation Bio builds on our commitment to work with both biotech and pharmaceutical companies alike to help ensure the availability and access to innovative treatments that address significant unmet medical needs for patients.”<\/p>\n

\n About ROS1+ NSCLC
<\/b>Each year, more than one million people globally are diagnosed with non-small cell lung cancer (NSCLC), the most\u00a0common form\u00a0of lung cancer. It is estimated that\u00a0approximately 2%\u00a0of patients with NSCLC have ROS1+ disease. About 35% of\u00a0patients newly\u00a0diagnosed 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.\u00a0<\/p>\n

\n About IBTROZI
<\/b>IBTROZI is an oral, potent,\u202fCNS-active, selective, next-generation ROS1 inhibitor therapy.\u202fOn June 11,\u202f2025,\u202ffollowing Priority Review and Breakthrough Therapy\u202fdesignations for both\u00a0TKI-naive and TKI-pretreated disease,\u202fthe U.S. Food and Drug Administration (FDA) approved IBTROZI for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC.\u202fLearn more at IBTROZI.com<\/a>.\u202f\u00a0<\/p>\n

\n Indication
<\/b>IBTROZI is\u00a0indicated\u00a0for the treatment of adult patients with locally advanced or metastatic ROS1+ non-small cell lung cancer (NSCLC).\u00a0<\/p>\n

\n IMPORTANT SAFETY INFORMATION FOR IBTROZI<\/b>\u00ae\u00a0(taletrectinib)<\/b><\/p>\n

\n WARNINGS AND PRECAUTIONS<\/b>\n <\/p>\n

\n Hepatotoxicity:<\/b>\u00a0Hepatotoxicity, 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.\u00a0Median\u00a0time to first onset of AST or ALT elevation was 15 days (range: 3 days to 20.8 months).\u00a0<\/p>\n

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\u00a0in\u00a00.3% and by hepatotoxicity in 0.6% of patients.\u00a0<\/p>\n

Concurrent elevations in AST or ALT \u22653 times the ULN and total bilirubin \u22652 times the ULN, with normal alkaline phosphatase, occurred in 0.6% of patients.\u00a0<\/p>\n

\n Interstitial Lung Disease (ILD)\/Pneumonitis:<\/b>\u00a0Severe, life-threatening, or fatal ILD or pneumonitis can occur.\u00a0ILD\/pneumonitis occurred in 2.3% of patients, including 1.1% Grade 3\/4. One fatal ILD case occurred at\u00a0the\u00a0400\u00a0mg\u00a0daily dose.\u00a0Median\u00a0time\u00a0to\u00a0first onset of ILD\/pneumonitis was 3.8 months (range:\u00a012 days\u00a0to 11.8 months).\u00a0<\/p>\n

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.\u00a0<\/p>\n

\n QTc Interval Prolongation<\/b>:\u202fQTc interval prolongation can occur, which can increase the risk for ventricular tachyarrhythmias (e.g.,\u00a0torsades\u00a0de pointes) or sudden death. IBTROZI prolongs the QTc interval in a concentration-dependent manner.\u00a0<\/p>\n

In patients who received IBTROZI and underwent at least one post baseline ECG,\u00a0QTcF\u00a0increase of >60\u202fmsec compared to baseline and\u00a0QTcF\u00a0>500 msec occurred in 13% and 2.6% of patients, respectively. 3.4% of patients experienced Grade \u22653.\u00a0Median\u00a0time 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\u00a0reduction each\u00a0occurred in 2.8% of patients.\u00a0<\/p>\n

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.\u00a0<\/p>\n

\n Hyperuricemia:<\/b>\u00a0Hyperuricemia can occur and\u00a0was\u00a0reported in 14% of patients, with 16% of these requiring urate-lowering medication without pre-existing gout or hyperuricemia. 0.3% of patients experienced Grade \u22653.\u00a0Median\u00a0time to first onset was 2.1 months (range: 7 days to 35.8 months). Dose interruption occurred in 0.3% of patients.\u00a0<\/p>\n

\n Myalgia with Creatine Phosphokinase (CPK) Elevation:<\/b>\u202fMyalgia with or without CPK elevation can occur. Myalgia occurred in 10% of patients.\u00a0Median\u00a0time to first onset was 11 days (range: 2 days to 10 months).\u00a0<\/p>\n

Concurrent myalgia with increased CPK within a 7-day\u00a0time\u00a0period\u00a0occurred in 0.9% of patients. Dose interruption occurred in 0.3% of patients with myalgia and concurrent CPK elevation.\u00a0<\/p>\n

\n Skeletal Fractures:<\/b>\u00a0IBTROZI 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%\u00a0Grade\u00a03. Some fractures occurred in the setting of a fall or other predisposing factors.\u00a0Median\u00a0time to first onset of fracture was 10.7 months (range:\u00a026 days\u00a0to 29.1 months). Dose interruption occurred in 0.3% of patients.\u00a0<\/p>\n

\n Embryo-Fetal Toxicity:<\/b>\u202fBased on literature, animal studies, and its mechanism of action, IBTROZI can cause fetal harm when administered to a pregnant woman.\u00a0<\/p>\n

\n ADVERSE REACTIONS<\/b>
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Among patients who received IBTROZI, the most\u00a0frequently\u00a0reported adverse reactions (\u226520%) were diarrhea (64%), nausea (47%), vomiting (43%), dizziness (22%), rash (22%), constipation (21%), and fatigue (20%). \u00a0<\/p>\n

The most\u00a0frequently\u00a0reported Grade 3\/4 laboratory abnormalities (\u22655%) were increased ALT (13%), increased AST (10%), decreased neutrophils (5%), and increased creatine phosphokinase (5%). \u00a0\u00a0<\/p>\n

\n DRUG INTERACTIONS<\/b>\n <\/p>\n