Bristol-Myers Squibb’s immunotherapy Opdivo can now be used to treat more patients with lung cancer and those with kidney cancer after regulators expanded the drug’s approved indications.
The European Commission has broadened the current label for Opdivo (nivolumab) to include the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) after prior chemotherapy, in addition to adult patients with advanced renal cell carcinoma (RCC) who have received prior therapy.
This approval significantly expands the existing lung cancer indication allowing the drug’s use in both metastatic squamous and non-squamous NSCLC patient populations, which together account for 85% of all lung cancer cases.
BMS says Opdivo is now the only PD-1 inhibitor approved in Europe to show superior overall survival in locally advanced or metastatic NSCLC, and the drug’s launch “will irrevocably change the treatment of this condition and represents one of the biggest advances in almost two decades,” noted Professor Dean Fennell, chair of Thoracic Medical Oncology, University of Leicester.
The drug is also the first PD-1 inhibitor approved to treat advanced kidney cancer patients who have received prior therapy, and the first medicine to demonstrate a significant improvement in overall survival compared to current standard therapy, Novartis Afinitor (everolimus), the firm said.
Opdivo was designated a Promising Innovative Medicine in both indications by the UK Medicines and Healthcare Products Regulatory Agency and was thus available to patients through the Early Access to Medicines Scheme.
Ironically, now that the drug has garnered regulatory approval for these patient populations access is now uncertain, despite incoming reforms designed to accelerate the cost appraisal and uptake of innovative new cancer medicines.