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Medicines licensing

FDA fast tracks nivolumab for advanced non-squamous non-small cell lung cancer

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

Source: BSIP SA / Alamy Stock Photo

The Food and Drug Administration has given nivolumab the green light to treat patients with advanced non-squamous non-small cell lung cancer whose disease has progressed despite treatment with platinum-based chemotherapy

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

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

The announcement on 9 October 2015 comes seven months after the FDA approved the same product for patients with advanced squamous NSCLC.

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

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

In the UK, nivolumab is licensed as a monotherapy for the treatment of advanced (unresectable or metastatic) 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. 

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2015.20069525

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