On Oct. 2, 2020, the Food and Drug Administration announced it had approved Bristol-Myers Squibb’s Opdivo (nivolumab) in combination with Yervoy (ipilimumab) to treat malignant pleural mesothelioma, a rare cancer caused by asbestos that affects the lining of the lungs.
This drug combination represents the first mesothelioma drug regimen that the agency has approved in 16 years. It’s the second FDA-approved systemic therapy for mesothelioma. The FDA approved pemetrexed in combination with cisplatin for this indication in 2004.
About 20,000 Americans are diagnosed with malignant pleural mesothelioma each year, according to the FDA. Pleural mesothelioma is an aggressive cancer with a poor prognosis. It’s caused by inhaling asbestos fibers. Over several years, these fibers cause inflammation in the lining of the lungs that leads to tumor growth.
“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 and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, said in a statement.
Opdivo and Yervoy work in combination to decrease tumor growth by enhancing the function of cells in the immune system called T-cells. Patients receive the drugs in intravenous infusions.
In a clinical trial of 605 patients with previously untreated unresectable malignant pleural mesothelioma, researchers found that an Opdivo and Yervoy combination increased survival compared to chemotherapy. Patients treated with chemotherapy survived for a median of 14.1 months, and those who received Opdivo and Yervoy survived for a median of 18.1 months.
Common side effects of Opdivo in combination with Yervoy include rash, diarrhea, musculoskeletal pain, fatigue, difficulty breathing, cough, itching and nausea. Yervoy can cause serious inflammation in healthy organs, including the colon, lungs, liver, kidneys and endocrine glands.
Asbestos is the primary cause of mesothelioma. The FDA says it “considers it unacceptable for cosmetics to be contaminated with asbestos.” In some cases, however, the mineral can contaminate products made with talc. Many consumer products contain talcum powder, including baby powder and makeup.
In March 2020, the FDA released the lab results of tests for asbestos in talc-containing cosmetic products. The results showed 43 samples were negative and nine were positive for asbestos.
In 2019, Johnson & Johnson recalled 33,000 bottles of Johnson’s Baby Powder after the FDA found a small amount of asbestos in one sample.
“Thousands of tests over the past 40 years repeatedly confirm that our consumer talc products do not contain asbestos. Our talc comes from ore sources confirmed to meet our stringent specifications that exceed industry standards,” Johnson & Johnson said in a statement regarding the recall.
In May 2020, the company announced it would stop selling talc-containing baby powder in the U.S. and Canada.
Johnson & Johnson faces talcum powder lawsuits that claim asbestos-contaminated baby powder and Shower-to-Shower products caused people to develop mesothelioma. It also faces more than 20,000 lawsuits that claim its talcum powder products caused ovarian cancer.
On Oct. 5, 2020, the pharmaceutical giant agreed to pay $100 million dollars to settle about 1,000 talcum powder lawsuits. This is the first time the company has agreed to a settlement in four years of litigation, Bloomberg reported.
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