Cookie policy: This site uses cookies (small files stored on your computer) to simplify and improve your experience of this website. Cookies are small text files stored on the device you are using to access this website. For more information please take a look at our terms and conditions. Some parts of the site may not work properly if you choose not to accept cookies.

Join

Subscribe or Register

Existing user? Login

Medicines licensing

Nivolumab granted positive scientific opinion under UK early access scheme

The UK’s medicines safety watchdog has given nivolumab a positive scientific opinion under the EAMS as a treatment for lung cancer (NSCLC) after prior chemotherapy in adults. In the image, micrograph of a cancerous tumour in the lung

Source: Moredun Animal Health Ltd / Science Photo Library

Patients with locally advanced or metastatic squamous non-small cell lung cancer may be eligible for treatment with nivolumab under the UK’s Early Access to Medicines Scheme

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. 

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2015.20068869

Have your say

For commenting, please login or register as a user and agree to our Community Guidelines. You will be re-directed back to this page where you will have the ability to comment.

Recommended from Pharmaceutical Press

Search an extensive range of the world’s most trusted resources

Powered by MedicinesComplete
  • Print
  • Share
  • Comment
  • Save
  • Print Friendly Version of this pagePrint Get a PDF version of this webpagePDF

Supplementary images

  • The UK’s medicines safety watchdog has given nivolumab a positive scientific opinion under the EAMS as a treatment for lung cancer (NSCLC) after prior chemotherapy in adults. In the image, micrograph of a cancerous tumour in the lung

Jobs you might like

Newsletter Sign-up

Want to keep up with the latest news, comment and CPD articles in pharmacy and science? Subscribe to our free alerts.