Bristol-Myers Squibb’s Opdivo Gains Expanded FDA Approval in Previously-Treated Metastatic Non-Small Cell Lung Cancer

The US drugs safety regulator has fast-tracked the approval of Opdivo (nivolumab) to extend its current use to a new group of patients with advanced lung cancer.

The Food and Drug Administration (FDA) has given Opdivo the approval to treat patients with advanced non-squamous non-small cell lung cancer (NSCLC) whose disease has progressed despite treatment with platinum-based chemotherapy.

The decision follows the results of a clinical trial of 582 patients with advanced NSCLC. The patients were given Opdivo or docetaxel after their disease progressed despite receiving platinum-based chemotherapy. Those who were treated with Opdivo lived for an average of 12.2 months compared with that were given docetaxel who lived for an average of 9.4 months. The tumours of 19% of patients treated with Opdivo either shrank or disappeared, compared with 12% of patients treated with docetaxel. The tumour benefits lasted 17 months for Opdivo patients compared with six months for the other group.

Opdivo was given FDA priority review status because of its potential to make a substantial impact on patient care.

Currently in the UK, Opdivo is licensed as a monotherapy for the treatment of advanced melanoma in adults.

A recommendation to change its marketing authorisation to include the treatment of locally advanced or metastatic squamous NSCLC after prior chemotherapy in adults was made by the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) on 24 September 2015. That recommendation still has to be ratified by the European Commission.


Industry News