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The First FDA-Approved Mesothelioma Drug in 15 Years

The First FDA-Approved Mesothelioma Drug in 15 Years On October 2, 2020, the first FDA-approved mesothelioma drug in 15 years hit the market. They approved a new combination of drugs for mesothelioma.

The combination of nivolumab with ipilimumab is now considered the first-line treatment. It is the go-to for adult patients with unresectable malignant pleural mesothelioma.

The FDA based approval on results from an open-label clinical trial. The results of a new study show outcomes of Mesothelioma patients over the last 2 years. This often was often six cycles of chemotherapy.

Patient survival using this new combination of drugs was an average of 18.1 months. This was an increase from 14.1 months for patients who only received chemotherapy.

More clinical pharmacology data also supported an alternative dosing regimen. This new treatment plan will reduce the number of required treatment visits.

Nivolumab and ipilimumab is the first FDA-approved mesothelioma drug since 2004.

Approved Treatment Options for Malignant Mesothelioma

Malignant pleural mesothelioma is an aggressive lung tumor from asbestos inhalation. In the United States, mesothelioma is rare and incidence rates are declining.

Cisplatin and pemetrexed were the first FDA-approved mesothelioma drugs before 2020. This original treatment was for patients who are not candidates for curative surgery.

The National Comprehensive Cancer Network guidelines provide some treatment options. But those combinations are not approved for mesothelioma treatment by FDA. And they are not approved by any other international regulatory agency.

The combination of nivolumab and ipilimumab is exciting. It is the first FDA-approved drug regimen for mesothelioma in over 15 years.

This approval provides a chemotherapy-sparing treatment option for patients. And it adds to the limited arsenal of available therapies for advanced mesothelioma.

Risk Management with Current Treatment Options

Malignant pleural mesothelioma is a rare, aggressive tumor of the lung pleura. It occurs most often due to asbestos exposure.

Most patients have unresectable mesothelioma by the time they are diagnosed. This means they are ineligible for surgery. Long-term survival is often very poor.

Unresectable malignant pleural mesothelioma is a life-threatening condition with poor survival.

There were some reported side effects to this new combination of treatment drugs. The most common adverse reactions were fatigue, musculoskeletal pain, and rash. Patients reported diarrhea, shortness of breath, nausea, decreased appetite, cough, and itchy skin.

The amount and severity of these reactions were consistent with existing treatment options. The incidence of infusion-related reactions was higher in the mesothelioma population.

The safety profile is acceptable in the treatment context of a life-threatening disease.


The approval of nivolumab and ipilimumab provides a chemotherapy-sparing option. It gives hope in the treatment of patients with previously untreated, unresectable mesothelioma.

Clinical trial results show a favorable benefit-risk profile and support this approval. The combination of nivolumab and ipilimumab marks a milestone. This is the first FDA-approved mesothelioma drug in over 15 years.

Despite this milestone, treatment options are still limited. Effective and long-lasting therapies remain an area of significant unmet need.


Nakajima, E. C., Vellanki, P. J., Larkins, E., Chatterjee, S., Mishra-Kalyani, P. S., Bi, Y., … & Donoghue, M. (2021). FDA Approval Summary: Nivolumab in Combination with Ipilimumab for the Treatment of Unresectable Malignant Pleural Mesothelioma. Clinical Cancer Research. https://doi.org/10.1158/1078-0432.CCR-21-1466


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