The UK’s medicines safety regulator has given nivolumab a positive scientific opinion under its Early Access to Medicines Scheme (EAMS) as a treatment for locally advanced or metastatic squamous non-small cell lung cancer (NSCLC).
The decision by the Medicines and Healthcare products Regulatory Agency (MHRA) means that doctors have access to benefit and risk information about the drug, a programmed death-1 immune checkpoint inhibitor, which they can choose to prescribe under their own responsibility. The package of information provided as part of the announcement also includes details of how clinicians can apply for funding for the drug.
The MHRA decision comes just a month after the European Medicines Agency (EMA) recommended that the drug should be granted a marketing authorisation for the same condition across Europe. That recommendation still has to be ratified by the European Commission (EC).
When the European marketing authorisation is approved, EAMS access to nivolumab will close to new applicants. However, those patients already enrolled under the scheme will continue to be eligible for treatment, says manufacturer Bristol-Myers Squibb.
The EAMS was launched in April 2014 as a way of bringing innovative new drugs to market that have not yet completed the traditional licensing process but potentially offer the only treatment option for patients suffering from life threatening or seriously debilitating disease.
Nivolumab is the first lung cancer drug to be given a positive scientific opinion under the EAMS.
National Institute for Health and Care Excellence (NICE) guidance for NHS use of nivolumab in lung cancer is due to be published in May 2016.