Opdivo approved via UK’s early drug access scheme

EMA

The UK's drug regulator has approved Bristol-Myers Squibb's new lung cancer drug Opdivo for use in the country under a new scheme design to speed up market access in the country.

The MHRA formally adopted a positive scientific opinion under the Early Access to Medicines Scheme (EAMS) for the firm's investigational PD-1 (programmed death-1) immune checkpoint inhibitor, Opdivo (nivolumab).

It has been approved as a treatment option for patients with locally advanced or metastatic squamous non small-cell lung cancer (NSCLC) after prior chemotherapy.

The drug was also granted a licence to treat late-stage melanoma in Europe just last week. In May, the drug received a positive opinion from the European Medicines Agency in NSCLC as a second-line therapy, but has not yet been given final approval, which is expected by September.

This latest EAMS decision will therefore allow UK patients access Opdivo ahead of its marketing authorisation in lung cancer from the European Commission.

For more details, go to: http://www.pmlive.com/pharma_news/opdivo_approved_via_uks_early_drug_access_scheme_768504

Michael Wonder

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Michael Wonder

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