The U.S. Food and Drug Administration (FDA) announced the approval of Opdivo (nivolumab) combined with Yervoy (ipilimumab) for first-line treatment of adults who have malignant pleural mesothelioma that cannot use alternative methods for removal such as surgery.
“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,” said Richard Pazdur, M.D., 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."
Malignant pleural mesothelioma (MPM) is a cancer of the lungs lining and is life-threatening. Cancer lines the lungs by inhalation of asbestos fibers that 20,000 Americans find themselves diagnosed with each year, according to the FDA.
MPM can account for the majority of the mesothelioma diagnoses and most are not able to remove the tumor via surgery. With the available treatment, the odds of survival are poor. Opdivo and Yervoy are monoclonal antibodies that decrease the growth of the tumor by increasing T-cell function when they are combined.
An open-label trial was done to examine the combination therapy. There were 605 trial patients with untreated unresectable MPM. The patients received an intravenous infusion of Opdivo every two weeks combined with Yervoy every six weeks for up to two years, or platinum-doublet chemotherapy that would be done up to six cycles. This continued until the disease advanced, unacceptable toxicity, or the therapy was completed for two years. The point of this trial was to decide if Opdivo combined with Yervoy enhanced the overall survival rate in comparison to chemotherapy treatment. Patients with Opdivo combined with Yervoy survived on average 18.1 months in comparison to chemotherapy survival average of 14.1 months.
The FDA gave Bristol-Myers Squibb Company the approval.
Alerts Sign-up