According to the federal agency, Opdivo (nivolumab) along with Yervoy (ipilimumab) marks the first regimen approved for mesothelioma in 16 years.
“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 news release. “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 mesothelioma is an aggressive cancer of the lining of the lungs, with 20,000 new cases in the U.S. each year. Upon diagnosis, most patients have a tumor that cannot be surgically removed, the FDA said, adding, “with currently available therapy, overall survival is generally poor.”
However, the newly approved drug combo involves monoclonal antibodies that are said to lower tumor growth by “enhancing T-cell function.”
A randomized trial involving 605 patients with malignant pleural mesothelioma revealed the drug combo outperformed chemotherapy in terms of overall survival by about four months (18.1 months vs 14.1 months, respectively).
Several of the most common side effects include fatigue, musculoskeletal pain, and rash, among others.
The FDA said it granted approval to Bristol-Myers Squibb, which recently announced findings from a separate trial using the same drug combo in high-risk melanoma patients against Opdivo alone, though “the addition of Yervoy to Opdivo in this trial did not result in a statistically significant improvement in recurrence-free survival (RFS) in the all-comer (intent-to-treat) population,” per a company news release.