Decision

EAMS Scientific Opinion: polatuzumab vedotin in combination with bendamustine and rituximab for the treatment of relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in adult patients who are not eligible for hematopoietic stem cell transplant

Early Access to Medicines Scheme (EAMS) scientific opinion was issued to Roche Products Limited in the treatment of relapsed/refractory diffuse large B-cell lymphoma in adult patients who are not eligible for hematopoietic stem cell transplant.

From:
Medicines and Healthcare products Regulatory Agency
Published
26 June 2019
Last updated
3 February 2020 — See all updates

This publication was withdrawn on

Granting of the EU licence to this scientific opinion. See expired early access to medicines scheme scientific opinions.

Documents

Polatuzumab vedotin - Public Assessment Report (PAR)

PDF, 660 KB, 3 pages

This file may not be suitable for users of assistive technology.

Request an accessible format.
If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email webupdates@mhra.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

Treatment protocol for patients

PDF, 177 KB, 7 pages

This file may not be suitable for users of assistive technology.

Request an accessible format.
If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email webupdates@mhra.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

Treatment protocol for healthcare professionals

PDF, 230 KB, 15 pages

This file may not be suitable for users of assistive technology.

Request an accessible format.
If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email webupdates@mhra.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

Treatment protocol on the pharmacovigilance system

PDF, 147 KB, 3 pages

This file may not be suitable for users of assistive technology.

Request an accessible format.
If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email webupdates@mhra.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

Polatuzumab vedotin - Background information for medical directors

PDF, 58.6 KB, 2 pages

This file may not be suitable for users of assistive technology.

Request an accessible format.
If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email webupdates@mhra.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

Details

This positive scientific opinion was issued to Roche Products Limited in the treatment of relapsed/refractory diffuse large B-cell lymphoma in adult patients who are not eligible for hematopoietic stem cell transplant.

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 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 26 June 2019
Last updated 3 February 2020 + show all updates

  1. Updated due to granting of the EU licence

  2. Changes of multiple contacts in Contacts section.

  3. First published.