The U.S. Food and Drug Administration (FDA) has approved a groundbreaking oral medication to treat a rare and aggressive form of advanced lung cancer that frequently spreads to the brain.
The drug, taletrectinib (brand name Ibtrozi), is designed for adults with ROS1-positive non-small cell lung cancer (NSCLC) that has metastasized or worsened. This targeted therapy offers new hope to roughly 3,000 U.S. patients and over 1 million people worldwide diagnosed annually with this hard-to-treat cancer.
Why This Approval Matters
NSCLC is the most common type of lung cancer and a leading cause of cancer deaths. About 2% of advanced cases are ROS1-positive, a subtype that grows aggressively and is often diagnosed in patients in their 50s, many with no smoking history.
A major challenge is the cancer’s tendency to spread to the brain—seen in 35% of patients at diagnosis and nearly 50% after treatment. Existing therapies struggle to control brain metastases, making Ibtrozi’s approval a critical advancement.
Clinical Trial Results
The FDA’s decision was based on two key studies:
Included 113 patients previously treated with a similar drug. 52-62% responded to Ibtrozi, with 83% maintaining benefits for at least six months.
Involved 157 treatment-naïve patients. 85-90% responded, and 63% saw sustained results for over a year.
Notably, Ibtrozi shrank brain tumors in 73% of new patients and 63% of pre-treated patients, according to Nuvation Bio, the drug’s manufacturer.
How Ibtrozi Works
Ibtrozi is a tyrosine kinase inhibitor (TKI) that blocks the defective ROS1 protein, slowing cancer growth. It is specially formulated to cross into the brain, offering longer disease control.
Dosage: Patients take 600 mg once daily on an empty stomach (no food 2 hours before or after). Treatment continues until cancer progresses or side effects become severe.
Safety & Side Effects
Common side effects include:
- Nausea
- Diarrhea
- Fatigue
- Dizziness
Serious risks include:
- Liver or lung complications
- Heart rhythm issues
- Muscle pain
- Harm to unborn babies (women should avoid pregnancy and breastfeeding during treatment)
Patients are advised to:
- Avoid sun exposure (use sunscreen).
- Inform doctors of all medications, especially acid reflux drugs.
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