Decision

Early access to medicines scheme (EAMS) scientific opinion: Atezolizumab as 1st line treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression ≥ 1%

EAMS scientific opinion given to Roche Products Limited for the 1st line treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression ≥ 1%

• From: Medicines and Healthcare products Regulatory Agency
• Published: 13 March 2019
• Last updated: 5 July 2019 — See all updates

This publication was withdrawn on 24 September 2019

Granting of the EU licence to this scientific opinion

Documents

Atezolizumab TNBC - Public assessment report

PDF, 667 KB, 3 pages

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Treatment protocol for healthcare professionals

PDF, 388 KB, 19 pages

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Treatment protocol for patients

PDF, 273 KB, 8 pages

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Treatment protocol on the pharmacovigilance system

PDF, 205 KB, 3 pages

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EAMs scientific opinion – background information for Medical Directors

PDF, 64.9 KB, 2 pages

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Details

This positive scientific opinion was issued to Roche Products Limited for Atezolizumab as 1st line treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression ≥ 1%

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

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@wales.gov.wales and Lynne Schofield, Head of Pharmacy and Prescribing policy at Lynne.Schofield@gov.wales.

Published 13 March 2019
Last updated 5 July 2019 + show all updates

1. 5 July 2019

   Updated treatment protocol for healthcare professionals

2. 24 June 2019

   Updated contact details for information and details regarding patient access

3. 13 March 2019

   First published.