The U.S. Food and Drug Administration (FDA) first approved nintedanib (Ofev) in 2014 as a treatment for progressive lung scarring. In Europe, a version of the drug named Vargatef was also approved for use in chemotherapy for lung cancer.
In 2016, the FDA granted Ofev orphan drug designation for mesothelioma in response to promising phase II clinical trial results.
This designation encourages drug development for rare diseases. Other clinical trials of Ofev for mesothelioma are ongoing.
How Does Ofev Work?
Ofev blocks tyrosine kinase, a type of enzyme that triggers scar-tissue growth and blood-vessel development.
Blocking tyrosine kinase also reduces tumor growth and promotes tumor-cell death in certain types of cancer.
Ofev is approved in the U.S. to treat idiopathic pulmonary fibrosis, a disease where scarring in the lungs makes it progressively harder to breathe. The drug can slow down the buildup of scar tissue in the lungs.
Asbestosis is a type of pulmonary fibrosis, so Ofev is a potential treatment for asbestosis.
A 2018 Clinical Cancer Research study explains how Ofev may be effective against malignant pleural mesothelioma as well.
Laboratory experiments showed Ofev inhibits mesothelioma cell growth and prevents tumors from growing their own blood vessels. The study results suggested Ofev may work better than bevacizumab, a similar drug being tested in mesothelioma chemotherapy.
|Alternate Names||Nintedanib, Vargatef|
|Dosage||200 mg twice daily|
|Drug Class||Tyrosine Kinase inhibitor|
|Medical Code||BIBF 1120|
|Interacting Drug||Erythromycin, rifampicin, carbamazepine, phenytoin, St. John’s wort, warfarin, carbamazepine|
|Medical Studies||Nintedanib Plus Pemetrexed/Cisplatin in Patients With Malignant Pleural Mesothelioma: Phase II Results From the Randomized, Placebo-Controlled LUME-Meso Trial|
|FDA Warning||Liver problems, gastrointestinal disorders, fetal toxicity, cardiovascular events, bleeding problems, gastrointestinal perforation|
Ofev in Mesothelioma Clinical Trials
Ofev has reached phase III in the clinical-trial process. If it continues to show strong results in coming years, the FDA may add it to the standard of care for mesothelioma.
In 2013, cancer centers around the world began to test Ofev for mesothelioma as part of a phase II and III clinical trial called LUME-Meso.
The trial recruited pleural mesothelioma patients with the epithelioid or biphasic cell type. The patients could not be eligible for surgery or have already received chemotherapy.
Participants in the trial were randomized into two groups. One group received standard chemotherapy plus Ofev, while the other group received chemotherapy plus a placebo. LUME-Meso is a double-blind trial, meaning neither patients nor their doctors knew who was receiving a placebo.
By 2016, the combination had proven safe, and the trial has proceeded to phase III. Now its goal is to confirm the combination is more effective than standard chemotherapy alone.
The phase III results are not expected until late 2019, but the phase II findings showed promise. A 2017 article in the Journal of Clinical Oncology detailed the outcomes for 87 participants.
Median survival was 20.6 months for epithelioid patients receiving Ofev, compared to 15.2 months for those receiving placebos.
Patients on Ofev were more likely to experience low white blood cell counts, but serious side effects were actually less common in the experimental group overall.
Though the LUME-Meso trial is no longer recruiting, pleural mesothelioma patients may be eligible for other clinical trials involving Ofev.
Side Effects of Ofev
The most common side effects of Ofev are gastrointestinal problems such as diarrhea, nausea and abdominal pain. Patients should alert their doctor immediately if they experience severe stomach pain, vomiting, sudden dizziness or bleeding problems.
Common Side Effects of Ofev
- Abdominal pain
- Liver enzyme elevation
- Loss of appetite
Rare Side Effects of Ofev
- Weight loss
- High blood pressure
- Joint pain
- Body aches
Women who are pregnant or breastfeeding should avoid taking Ofev. The drug is also not recommended for people with liver problems.
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