Home » BMS Receives EU Approval for Opdivo Combo for Pleural Mesothelioma
BMS Receives EU Approval for Opdivo Combo for Pleural Mesothelioma
Drugs Submissions and Approvals
The European Commission has granted marketing authorization for Bristol Myers Squibb’s Opdivo (nivolumab) plus Yervoy (ipilimumab) as a first-line therapy for adults with unresectable malignant pleural mesothelioma.
A phase 3 study of more than 600 patients showed that the Opdivo-Yervoy combination increased overall survival vs. chemotherapy (pemetrexed and cisplatin or carboplatin). Patients in the Opdivo-Yervoy arm had a median overall survival of 18.1 months vs. 14.1 months in the chemotherapy cohort.
The Opdivo-Yervoy combination has received previous EU marketing authorizations for other advanced cancers, including nonsmall-cell lung cancer, melanoma and renal cell carcinoma.