Decision

Early access to medicines scheme (EAMS) scientific opinion: avelumab in combination with axitinib for first-line treatment of advanced renal cancer

EAMS scientific opinion given to Merck Serono Ltd in the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).

Documents

Avelumab EAMS - Public Assessment Report (PAR) Expired

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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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EAMs scientific opinion – background information for Medical Directors

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Details

This positive scientific opinion was issued to Merck Serono Ltd for avelumab in combination with axitinib in the treatment of adult patients with advanced renal carcinoma (RCC) who have not received prior systemic therapy. The scientific opinion includes:

  • a public assessment report
  • a treatment protocol:
    • for healthcare professionals
    • for patients
    • on the pharmacovigilance system
    • EAMs scientific opinion – background information for 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 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, Chief Pharmaceutical Officer at Andrew.Evans@gov.wales and Lynne Schofield, Head of Pharmacy and Prescribing policy at Lynne.Schofield@gov.wales.
Published 15 July 2019
Last updated 4 November 2019 + show all updates
  1. We have updated Avelumab EMAMS PAR as it was been granted a EU licence

  2. First published.