BMS Receives EU Approval for Opdivo Combo for Pleural Mesothelioma

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.