FDA clears first treatment for mesothelioma in 16 years

FDA cleared the first treatment for mesothelioma in 16 years: nivolumab (Opdivo) in combination with ipilimumab (Yervoy).

The Bristol-Myers Squibb medication is for adults with malignant pleural mesothelioma that cannot be removed by surgery.

The approval “provides a new treatment that has demonstrated an improvement in overall survival for patients with malignant pleural mesothelioma,” said Richard Pazdur, MD, 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, in a press release.

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Malignant pleural mesothelioma is a rare cancer with limited treatment options, said study investigator Anne S. Tsao, MD, professor, section chief of Thoracic Medical Oncology, and director of the Mesothelioma Program at The University of Texas M.D. Anderson Cancer Center, in a Bristol-Myers Squibb press release.

“When it is diagnosed in advanced stages, the five-year survival rate is approximately 10%. The survival results from the CheckMate-743 trial show that the combination of nivolumab and ipilimumab could become a new front-line standard of care option.”

This is the third indication for an Opdivo plus Yervoy combination in the first-line treatment of a form of thoracic cancer.

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The combination is also approved by FDA as a first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) and in combination with limited chemotherapy for the first-line treatment of adult patients with metastatic or recurrent NSCLC with no EGFR or ALK genomic tumor aberrations regardless of PD-L1 expression.

Opdivo plus Yevoy was evaluated during a randomized, open-label trial in 605 patients with previously untreated unresectable MPM. Patients who received the combination treatment survived a median of 18.1 months, while patients who underwent chemotherapy survived a median of 14.1 months.

At two years, 41% of patients treated with Opdivo and Yervoy were alive, compared to 27% with chemotherapy.

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