Published

May 7, 2025

Atezolizumab [ATE1]

The first line treatment of locally advanced or metastatic urothelial cancer in patients who are ineligible for cisplatin- based chemotherapy and whose tumours have PD-L1 expression of 5% or more where all the following criteria are mett:

  1. An application is being made by and the first cycle of systemic anti-cancer therapy with atezolizumab 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-L1 treatments including pneumonitis, colitis, nephritis, endocrinopathies, hepatitis and skin toxicities.
  3. The patient has histologically or cytologically documented transitional cell carcinoma of the urothelial tract
  4. The patient has disease that is either locally advanced (ie T4b any N or any T N2-3 disease) or metastatic (any T any N M1 disease)
  5. The patient has not received previous chemotherapy for inoperable locally advanced or metastatic urothelial cancer
  6. The patient has EITHER not received previous adjuvant chemotherapy, neoadjuvant chemotherapy or chemo-radiotherapy OR if previously treated with platinum-based chemotherapy whether as adjuvant chemotherapy or as neoadjuvant chemotherapy or with chemo-radiotherapy, has relapsed more than 12 months since completing the platinum-based chemotherapy. Patients meeting this criterion are eligible to be considered as treatment naïve for locally advanced/ metastatic disease but must satisfy all other criteria.
  7. The patient has an ECOG performance status (PS) of 0, 1 or 2. Note: treatment of patients of performance status 2 should only proceed with caution as there is limited safety data on PS 2 patients with urothelial cancer treated with atezolizumab.
  8. The patient is ineligible for platinum-based chemotherapy, due to one or more of the following: * impaired renal function (EDTA-assessed glomerular filtration rate >30 and <60mls/min) * hearing loss of 25dB as assessed by formal audiometry * NCI CTCAE grade 2 or worse peripheral neuropathy * ECOG PS 2
  9. The patient’s urothelial tumour has undergone PD-L1 testing
  10. A PD-L1 expression of >=5% has been recorded and the measurement used for PD-L1 testing is defined as the presence of discernible >=5% of tumour area occupied by tumour cells, associated intra-tumoural and contiguous peri-tumoural desmoplastic stroma. Please document the actual score for tumour infiltrating immune cell PD-L1 expression:_____________
  11. The patient has not received prior treatment with an anti PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTL-4) antibody unless the patient completed or discontinued checkpoint inhibitor immunotherapy as part of adjuvant or neoadjuvant therapy without disease progression on treatment and at least 12 months elapsed between the date of last immunotherapy treatment and the date of first diagnosis of relapse with recurrent or metastatic disease. Note: NHS England does not commission any re-treatment with checkpoint inhibitor therapy for patients who have discontinued or completed previous checkpoint inhibitor therapy for the locally advanced/metastatic indication. Please mark below if the patient has received previous checkpoint inhibitor therapy and in which setting:
  • the patient has never received any immunotherapy for urothelial cancer. If so, please type ‘n/a’ in the ‘Time gap’ box below
  • the patient has previously been treated with adjuvant immunotherapy for urothelial cancer and discontinued immunotherapy without disease progression and at least 12 months prior to the first diagnosis of disease relapse. Please document in the box below the time gap in months between completion of previous adjuvant immunotherapy and first diagnosis of disease relapse stable disease at the end of 1st line chemotherapy
  • the patient has previously been treated with neoadjuvant treatment containing immunotherapy for urothelial cancer and discontinued immunotherapy without disease progression and at least 12 months prior to the first diagnosis of disease relapse. Please document in the box below the time gap in months between completion of previous neoadjuvant immunotherapy and first diagnosis of disease relapse Time gap in months after completion of previous adjuvant or neoadjuvant or maintenance checkpoint inhibitor immunotherapy and first diagnosis of disease relapse:____________
  1. The patient has no symptomatically active brain metastases or leptomeningeal metastases
  2. Atezolizumab will be administered as monotherapy either subcutaneously at a dose of 1875mg every 3 weeks or intravenously at a dose of 1200mg every 3 weeks or 1680 mg every 4 weeks.
  3. A formal medical review as to whether treatment with atezolizumab should continue or not will be scheduled to occur at least by the end of the third cycle of treatment.
  4. The patient will be treated until loss of clinical benefit or excessive toxicity or patient choice to discontinue treatment, whichever is the sooner. Note: there is no stopping rule for this indication.
  5. When a treatment break of more than 3 months beyond the expected 3- or 4-weekly cycle is needed, a treatment break approval form will be completed to restart treatment.
  6. Atezolizumab will otherwise be used as set out in its Summary of Product Characteristics (SPC).

NHS funded From: 25 January 2022

Form version:

CDF Managed Access: NA

NICE Technology Appraisal: TA739 (27 October 2021)

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 13 May 2025 at 19:45.

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.

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