Decision

Early access to medicines scheme (EAMS) scientific opinion: Nivolumab for treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal cancer after prior chemotherapy

EAMS scientific opinion issued to Bristol-Myers Squibb Pharmaceuticals Limited for Nivolumab as monotherapy treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal, squamous cell carcinoma (OSCC) after prior fluoropyrimidine- and platinum-based chemotherapy.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 8 June 2020
• Last updated: 20 August 2020 — See all updates

Documents

Nivolumab - Public Assessment Report (PAR)

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Nivolumab - Public Assessment Report (PAR)

PDF, 715 KB, 3 pages

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Nivolumab: Information for NHS Medical Directors

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Nivolumab: Information for NHS Medical Directors

PDF, 109 KB, 4 pages

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Nivolumab: Information for healthcare professionals

PDF, 326 KB, 17 pages

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Nivolumab: Information for patients

PDF, 220 KB, 8 pages

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Nivolumab: Information on the Pharmacovigilance System

PDF, 138 KB, 4 pages

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Details

This positive scientific opinion was issued to Bristol-Myers Squibb Pharmaceuticals Limited for Nivolumab as monotherapy treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal, squamous cell carcinoma (OSCC) after prior fluoropyrimidine- and platinum-based chemotherapy.

The scientific opinion includes:

• public assessment report
• a treatment protocol:
  • for healthcare professionals
  • for patients
  • on the pharmacovigilance system
• background information for NHS Medical Directors

Contacts

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 Chief Pharmaceutical Officer 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 at medicines.policy@gov.scot.

For information about access in Wales, contact the Welsh Government Health and Social Services Group by emailing Andrew Evans, Chief Pharmaceutical Officer or Lynne Schofield, Head of Pharmacy and Prescribing policy at Pharmacyand.PrescribingBranch@gov.wales.

Published 8 June 2020
Last updated 20 August 2020 + show all updates

1. 20 August 2020

   Updated PDF: Nivolumab information for healthcare professionals

2. 8 June 2020

   First published.