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Opdivo/Yervoy combo secures FDA approval for malignant pleural mesothelioma

Published on 06/10/20 at 12:56pm

Bristol Myers Squibb’s therapy regimen of Opdivo (nivolumab) in combination with Yervoy (ipilimumab) has secured FDA approval for the first-line treatment of unresectable malignant pleural mesothelioma, a potentially life-threatening lung cancer caused by asbestos fibre insulation, and one that sees around 20,000 new diagnoses a year in the US.

The combo was tested in 605 participants, with each receiving fortnightly intravenous infusions of Opdivo alongside intravenous infusions of Yervoy every six weeks for up to two years, or until disease progression or unacceptable toxicity was reached.

The combo was approved based on data supporting its overall survival benefit: patients receiving Opdivo plus Yervoy demonstrated a median overall survival rate of 18.1 months, compared to a median of 14.1 months in those receiving up to six cycles of platinum-doublet chemotherapy.

“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,” remarked 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. “In 2004, FDA approved pemetrexed in combination with cisplatin for this indication, and now patients now have an important, additional treatment option after more than a decade with only one FDA-approved drug regimen.”

The FDA’s decision makes the combo the second systemic therapy approved by the regulator for the treatment of mesothelioma, and marks the first regimen to be authorised in the US in this indication in 16 years.

Matt Fellows

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