Published

May 11, 2025

Dostarlimab [DOS1]

Dostarlimab monotherapy for patients with microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) recurrent/advanced endometrial carcinoma after prior platinum-based chemotherapy where the following criteria have been met:

  1. This application is being made by and also that the first cycle of systemic anti-cancer therapy with dostarlimab will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
  2. The prescribing clinician is fully aware of the management of and the treatment modifications that may be required for immune-related adverse reactions due to anti-PD-1/PD-L1 treatments including pneumonitis, colitis, nephritis, endocrinopathies, hepatitis and skin toxicity.
  3. The patient has a proven histological diagnosis of endometrial carcinoma. Please mark below whether the histology in this patient is endometrioid or not:
  • the histology is of endometrioid type or
  • the histology is of non-endometrioid type
  1. The patient has recurrent or locally advanced or metastatic disease. Please mark below which of the following scenarios best describes the type of recurrent disease the patient has:
  • the patient previously had a hysterectomy and relapsed with local recurrence only or
  • the patient previously had a hysterectomy and relapsed with distant disease only or
  • the patient previously had a hysterectomy and relapsed with both local recurrence and distant disease or
  • the patient previously had locally advanced disease, did not have surgery and has relapsed with local recurrence only or
  • the patient previously had locally advanced disease, did not have surgery and has relapsed with distant disease only or
  • the patient previously had locally advanced disease, did not have surgery and has relapsed with both local recurrence and distant disease or
  • the patient first presented with distant spread
  1. The patient’s tumour has a documented presence of microsatellite instability-high (MSI-H) or DNA mismatch repair deficiency (dMMR) confirmed by validated testing.
  2. The patient has progressive disease during or following previous platinum-based therapy for recurrent/locally advanced/metastatic endometrial carcinoma. Please mark below whether the patient has been previously treated with 1 course or >1 courses of treatment with platinum-based chemotherapy for recurrent/locally advanced/metastatic endometrial carcinoma:
  • 1 previous course of treatment with platinum-based chemotherapy for recurrent/locally advanced/metastatic endometrial carcinoma or

  • 1 previous courses of treatment with platinum-based chemotherapy for recurrent/locally advanced/metastatic endometrial carcinoma NB A course of treatment consists of a series of cycles of chemotherapy.

  1. The patient has an ECOG performance status (PS) of 0 or 1.
  2. The patient has no symptomatic brain or leptomeningeal metastases.
  3. The patient has not received any prior treatment with an anti-PD-1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody unless the patient has been treated with dostarlimab in a company early access scheme and all other treatment criteria on this form apply. Please mark below which clinical scenario applies to this patient:
  • the patient has not received any previous anti-PD-1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody therapy for endometrial carcinoma
  • the patient has received dostarlimab for recurrent/locally advanced/metastatic endometrial carcinoma via a company early access scheme and all other treatment criteria on this form apply
  1. Dostarlimab will be administered as monotherapy as follows: dostarlimab 500mg given for a maximum of 4 cycles every 3 weeks and then dostarlimab 1000mg is continued every 6 weeks.
  2. Dostarlimab will be stopped on disease progression or unacceptable toxicity or withdrawal of patient consent, whichever occurs first. Note: there is no stopping rule for dostarlimab in this endometrial carcinoma indication and hence patients continuing to benefit from dostarlimab after 2 years of treatment can continue on dostarlimab if the patient and clinician agree. Note: once dostarlimab is stopped for disease progression or unacceptable toxicity or withdrawal of patient consent, dostarlimab cannot be re-started.
  3. A formal medical review as to whether treatment with dostarlimab should continue will occur at least by the end of the 2nd 3-weekly cycle of treatment.
  4. Where a treatment break of more than 12 weeks beyond the expected 3- or 6-weekly cycle length is needed, the prescribing clinician will complete a treatment break approval form to restart treatment, including indicating as appropriate if the patient had an extended break because of COVID 19.
  5. Dostarlimab will be otherwise used as set out in its Summary of Product Characteristics (SPCs).

CDF funded From: 08 February 2022

Form version:

CDF Managed Access: Yes

NICE Technology Appraisal: NA (NA)

Current Form Version

Note

The data on this page was produced using version 1.361 of the CDF list, downloaded from an archive of NHS England’s website on 08 May 2025 at 22:10.

If NHS England has published a new version of the CDF List but this site has not yet accessed that, this form may be out of date. Additionally, if any update has occurred without NHS England noting it as a change, this page will be out of date.