Decision

Early access to medicines scheme (EAMS) scientific opinion: Nivolumab to treat advanced or recurrent gastric or gastroesophageal junction cancer after two or more systemic therapies

EAMS scientific opinion given to Bristol-Myers Squibb Pharmaceuticals Limited for Nivolumab to treat advanced or recurrent gastric or gastroesophageal junction cancer after two or more systemic therapies, including the public assessment report.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 21 December 2017
• Last updated: 4 June 2018 — See all updates

This publication was withdrawn on 29 August 2018

Additional information: the company has informed the MHRA that it has withdrawn from the drug licensing process and the EAMS. The EAMS will close to new patients on the 16 August 2018. More information about the withdrawal from the drug licensing process can be found on the EMA webpage.

Documents

Nivolumab - Public assessment report

PDF, 1.2 MB, 3 pages

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Treatment protocol for patients

PDF, 168 KB, 8 pages

Treatment protocol for healthcare professionals

PDF, 4.51 MB, 20 pages

Treatment protocol on the pharmacovigilance system

PDF, 226 KB, 4 pages

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Nivolumab - background information for medical directors

PDF, 69.9 KB, 2 pages

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Details

This positive scientific opinion was issued to Bristol-Myers Squibb Pharmaceuticals Limited to treat advanced or recurrent gastric or gastroesophageal junction cancer after two or more systemic therapies.

The scientific opinion includes:

• a public assessment report
• a treatment protocol:
  • for healthcare professionals (new safety information was included on 31 May 2018)
  • for patients (new safety information was included [May 2018])
  • on the pharmacovigilance system
  • EAMs scientific opinion – background information for Medical Directors

Contact

Information and details regarding patient access

For new patients wishing to access EAMS medicines in England, trusts must register patients on the NHS England web based registration system. Queries to NHS England regarding the scheme can be submitted to england.eams@nhs.net.

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@gov.scot and Rosemarie.parr@gov.scot

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 21 December 2017
Last updated 4 June 2018 + show all updates

1. 4 June 2018

   2 new treatment protocol attachments. New email contact for Scottish...

2. 4 June 2018

   Changes include replacing 2 treatment protocol documents (HCP and Patient). Also change of contact for Scottish Government Directorate General Health & Social Care and new text added to list of the scientific opinion.

3. 21 December 2017

   First published.