The U.S. Food and Drug Administration recently approved a new drug combination for treatment for mesothelioma, the first new treatment to come along for the asbestos-related cancer, which has the subject of mesothelioma class action lawsuits, in 16 years.

Based on clinical trials, the FDA said there was sufficient evidence to give the new immunotherapy-based approach – a combination of nivolumab and ipilimumab – its seal of approval. The pairing can now be prescribed as a “first-line treatment of adults with malignant pleural mesothelioma that cannot be removed by surgery,” the FDA’s announcement said.

“Today’s approval of nivolumab plus ipilimumab provides a new treatment that has demonstrated an improvement in overall survival for patients with malignant pleural mesothelioma,” Dr. Richard Pazdur, director of the FDA’s Oncology Center of Excellence, was quoted in the announcement as saying.

The last and only other drug treatment approved for malignant pleural mesothelioma came in 2004, when the FDA sanctioned the use of pemetrexed in combination with cisplatin.

“Patients now have an important, additional treatment option after more than a decade with only one FDA-approved drug regimen,” Pazdur said.

The new combination therapy, classified as an immunotherapy approach, can stem the growth of tumors by enhancing T-cell function.

T-cells are generated by the body’s immune system to fight off disease.

Mesothelioma At a Glance

Mesothelioma is a rare cancer and the only form of cancer directly caused by exposure to asbestos. It can take 30 to 40 years for symptoms of the disease to surface, according to the University of Pennsylvania’s Perelman School of Medicine, and it occurs in the chest (pleural mesothelioma), the abdomen (peritoneal mesothelioma), or around the heart (pericardial mesothelioma).

Patients who have mesothelioma often experience the symptoms of fever, excessive sweating, fatigue, weight loss, blood clots, and loss of appetite. Mesothelioma of the abdomen also produces belly pain, swelling of the abdomen, nausea and vomiting, and constipation, the American Cancer Society says.

There is no cure for mesothelioma.

In the early stages of the disease, treatment for mesothelioma might include surgery to remove the cancerous tissue and a combination of chemotherapy, radiation, and immunotherapy to eradicate any remaining cancer cells. If the disease isn’t caught until the late stages, chemotherapy and radiation might be prescribed in addition to other therapies to suppress symptoms and make the patient comfortable, according to the Mayo Clinic.

The Path to the New Treatment for Mesothelioma

Around 20,000 people are diagnosed with mesothelioma in the United States each year, most of whom have malignant pleural mesothelioma, according to reporting by HCPLive, an online resource for clinical news and information. The majority of those people have inoperable tumors by the time they are diagnosed, the publication says, and “the overall survival is generally poor with the current available therapy.”

The FDA’s approval of the new drug combination to treat inoperable malignant pleural mesothelioma was based on the randomized, open-label CheckMate trial with 605 patients, HCPLive and Medscape reported.

The trial compared the new immunotherapy with a traditional chemotherapy regimen. Participants either got intravenous infusions of nivolumab every two weeks and intravenous infusions of ipilimumab every six weeks for as long as two years or immunotherapy-based chemotherapy for as many as six cycles, Medscape said.

The results, which were presented at the World Congress on Lung Cancer 2020, showed the nivolumab-plus-ipilimumab treatment achieved a “statistically significant improvement in overall survival,” according to Medscape. Two years after taking the immunotherapy drug cocktail, 41% of patients were still alive while 27% of those taking the traditional chemotherapy were still alive. The median length of survival after the immunotherapy treatment was 18.1 months. After the chemotherapy treatment, it was 14.1 months.

The most common adverse reactions, which occurred in less than 20% of the patients participating in the trial, were fatigue, muscle pain, rash, diarrhea, nausea, decreased appetite, shortness of breath, cough, and skin irritation, the FDA reported.

Dr. Paul Baas of the Netherlands Cancer Institute lead the trial and presented the findings at the World Congress on Lung Cancer 2020. During the presentation, he said the nivolumab-ipilimumab treatment for mesothelioma should now “be considered as a new standard of care,” the website Healio reported.

The Bristol-Meyers Squibb Company manufactures nivolumab under the brand name Opdivo and ipilimumab under the brand name Yervoy.