Decision

Dostarlimab in the treatment of endometrial cancer

EAMS scientific opinion issued to GlaxoSmithKline UK Limited for dostarlimab in combination with platinum-containing chemotherapy for the treatment of adult patients with mismatch repair deficient (dMMR) / microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer and who are candidates for systemic therapy.

From:
Medicines and Healthcare products Regulatory Agency
Published
5 July 2023
Last updated
21 November 2023 — See all updates

This publication was withdrawn on

EAMS SO expired: 16 October 2023

Documents

Dostarlimab: Public Assessment Report (PAR)

PDF, 410 KB, 3 pages

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Dostarlimab: Treatment protocol Information for healthcare professionals

PDF, 419 KB, 23 pages

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Dostarlimab: Treatment protocol Information for patients

PDF, 237 KB, 11 pages

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Dostarlimab: Information for NHS Medical Director

PDF, 139 KB, 5 pages

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Dostarlimab: Treatment protocol Information on Pharmacovigilance system

PDF, 146 KB, 5 pages

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Details

This product is in a winding down period where the EAMS Scientific Opinion remains in effect.

For the full EAMS indication please see section 4.1 of the Treatment protocol: Information for healthcare professionals.

The scientific opinion includes:

  • a public assessment report (PAR)
  • a treatment protocol:
    • for healthcare professionals
    • for patients
    • on the pharmacovigilance system
  • Information for NHS Medical Directors

Updates to this page

Published 5 July 2023
Last updated 21 November 2023 + show all updates

  1. Note added to state that 'This product is in a winding down period where the EAMS Scientific Opinion remains in effect'

  2. First published.

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