Bristol Myers Squibb (BMS) has secured approval for Opdivo (nivolumab) and Yervoy (ipilimumab) combination from the US Food and Drug Administration (FDA) for the first-line treatment of unresectable malignant pleural mesothelioma (MPM) in adults.
The approval is for Opdivo 360 mg every three weeks with 1 mg/kg every six weeks (injections for intravenous use) of Yervoy (ipilimumab).
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: “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.
“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.”
According to the FDA, malignant pleural mesothelioma (MPM) is a life-threatening cancer of the lining of lungs resulting from inhaling asbestos fibers. Nearly 20,000 Americans are diagnosed with malignant pleural mesothelioma each year, said the FDA.
The FDA approval for the Opdivo, Yervoy combination therapy for malignant pleural mesothelioma was driven by a pre-specified interim analysis from the CheckMate -743 study.
In the phase 3 trial held in 605 patients with previously untreated unresectable malignant pleural mesothelioma, Opdivo + Yervoy showed superior overall survival (OS) compared to the platinum-based standard of care chemotherapy, with a median OS (mOS) of 18.1 months versus 14.1 months, respectively.
The results of the late-stage study were seen after 22.1 months of minimum follow-up. At two years, 41% of patients who were subjected to the Opdivo + Yervoy combination were alive and 27% with chemotherapy.
Opdivo + Yervoy is now the first and only immunotherapy treatment for previously untreated unresectable malignant pleural mesothelioma. It is also the third indication for Opdivo + Yervoy-based treatments for the treatment of thoracic cancers and seventh indication overall.
Adam Lenkowsky – general manager and head, U.S., Oncology, Immunology, Cardiovascular, Bristol Myers Squibb said: “Thoracic cancers can be complex and difficult to treat, and we are focused on developing immunotherapy options that may have the potential to extend patients’ lives.
“Just a few months ago, Opdivo + Yervoy-based combinations received two first-line indications for certain patients with non-small cell lung cancer. Now, Opdivo + Yervoy is approved for use in another type of thoracic cancer, previously untreated unresectable MPM.
“With today’s announcement, Opdivo + Yervoy becomes the first new systemic therapy approved in more than 15 years in this setting, and may offer these patients a chance for a longer life.”