Decision

Early access to medicines scheme (EAMS) scientific opinion: nivolumab for non-squamous non-small cell lung cancer (NSCLC)

Information on the EAMS scientific opinion given to nivolumab for non-squamous non-small cell lung cancer (NSCLC), including the public assessment report.

This publication was withdrawn on

The EAMS opinion for nivolumab for non-squamous non-small cell lung cancer (NSCLC) has been withdrawn as the marketing authorisation has been adopted by the European Commission.

Documents

Nivolumab EAMS public assessment report (PAR)

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Treatment protocol for patients

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Treatment protocol for healthcare professionals

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Treatment protocol on the pharmacovigilance system

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Details

This positive scientific opinion was issued to Bristol-Myers Squibb Pharmaceutical Limited for nivolumab for the treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) after prior chemotherapy in adult patients whose tumours express programmed death ligand-1 (PD-L1).

The scientific opinion includes:

  • a public assessment report
  • a treatment protocol:
    • for healthcare professionals
    • for patients
    • on the pharmacovigilance system

Contact

Information and details regarding patient access

For new patients wishing to access EAMS medicines in England, trusts must submit an application form to england.eams@nhs.net to register the patient with NHS England. The form itself can be requested from the same dedicated EAMS email address. Plans are underway to introduce a web based application form as soon as possible. Trusts will be informed when this is available.

For information about access in Northern Ireland, contact Mark Timoney, Chief Pharmaceutical Officer at Mark.Timoney@dhsspsni.gsi.gov.uk and Joe Magee, Secondary Care Directorate at Joe.Magee@dhsspsni.gov.uk.

For information about access in Scotland contact the Scottish Government Directorate General Health & Social Care email John.Hannah@scotland.gsi.gov.uk and Kathryn.Fergusson@scotland.gsi.gov.uk.

For information about access in Wales, contact the Welsh Government Department of Health and Social Services by emailing Andrew Evans, Interim Chief Pharmaceutical Officer at Andrew.Evans@wales.gsi.gov.uk and Karen Eveleigh, Head of Pharmacy and Prescribing policy at Karen.Eveleigh@wales.gsi.gov.uk.

Published 5 February 2016