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.

Documents

Polatuzumab vedotin - Public Assessment Report (PAR)

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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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Polatuzumab vedotin - Background information for medical directors

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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 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 26 June 2019