EU Broadens Scope for Opdivo
Bristol-Myers Squibb’s cancer drug Opdivo can now be used to treat more patients with lung cancer or kidney cancer after European regulators expanded its indications. The EU Commission has broadened Opdivo’s use to include the treatment of adults with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) after prior chemotherapy, in addition to patients with advanced renal cell carcinoma (RCC) who have also received prior therapy.
The approval significantly extends the existing lung cancer indication allowing the drug’s use in both metastatic squamous and non-squamous NSCLC patients, which together account for around 85% of all lung cancer cases.
Bristol-Myers Squibb said Opdivo is now the only PD-1 inhibitor approved in Europe to have shown a significant survival advantage in two separate Phase 3 trials and offers a much-needed new treatment option.
The drug is also the first approved PD-1 inhibitor for treating patients with advanced kidney cancer, and the first medicine to demonstrate a significant improvement in overall survival compared to the current standard therapy everolimus, which is marketed by Novartis as Afinitor.
