Is Opdualag approved in Europe?

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asked Oct 16, 2023 in Diseases Conditions by ReafeKris (1,960 points)
Is Opdualag approved in Europe?

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answered Jun 21, 2024 by Ameristands (5,360 points)
Opdualag is approved in Europe and received a marketing authorization that is valid throughout the EU and Europe on September 15 2022.

Opdualag is an FDA approved drug.

Opdualag also known as Nivolumab/relatlimab, which is sold under the brand name Opdualag, is a fixed-dose combination medication use to treat melanoma.

The drug Opdualag also contains nivolumab, a programmed death receptor-1 blocking antibody, and relatlimab, a lymphocyte activation gene-3 blocking antibody.

The drug Opdualag is given by intravenous infusion.

Opdualag is a prescription medicine used to treat Adults who have a type of skin cancer called melanoma that has spread or cannot be removed by surgery (advanced melanoma).

For people receiving Opdivo plus Opdualag, the 12-, 24- and 36-month progression-free survival rates were 48%, 38% and 31%, respectively. Overall survival rates were 77%, 62% and 54%, at these time points, respectively, with a 48-month overall survival rate of 52%.

Opdualag is a new FDA-approved melanoma treatment that combines two different immunotherapies to help energize your immune system against melanoma.

Once energized, your immune system attacks and destroys melanoma cells.

Severe or fatal cases of reactions when taking Opdualag have been reported for some of these adverse reactions which include cardiac/vascular: myocarditis, pericarditis, vasculitis; nervous system: meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome and nerve paresis.

Treatment with Opdualag should be continued as long as clinical benefit is observed or until treatment is no longer tolerated by the patient.

Dose escalation or reduction is not recommended.

Opdualag is an immunotherapy treatment that works with some of the T cells of your immune system.

Learning more about this treatment can help you have better conversations with your healthcare team when discussing treatment decisions.

The cost of Opdualag is $765.61 for 20 milliliters or around $15,312.19 for full course treatment.

Opdualag injection is taken as a 30-minute intravenous infusion.

IV=intravenous; q4w=every 4 weeks.

Opdualag received a marketing authorization valid throughout the EU on 15 September 2022.

The recommended dosage of OPDUALAG for adult patients and pediatric patients 12 years of age or older who weigh at least 40 kg is 480 mg nivolumab and 160 mg relatlimab administered intravenously every 4 weeks until disease progression or unacceptable toxicity occurs.

Nivolumab and relatlimab belong to a class of drugs known as monoclonal antibodies.

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