Avelumab [AVE4]

Avelumab monotherapy for the maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma who have just completed and not progressed on 1st line platinum-containing combination chemotherapy where the following criteria have been met:

  1. This application is being made by and the first cycle of systemic anti-cancer therapy with avelumab monotherapy 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 toxicity.
  3. The patient has a histologically confirmed diagnosis of urothelial carcinoma.
  4. The patient has locally advanced or metastatic disease.
  5. The patient has recently completed 1st line combination chemotherapy with either the combination of gemcitabine plus cisplatin or gemcitabine plus carboplatin. Please enter below whether the patient commenced 1st line chemotherapy with either gemcitabine plus cisplatin or gemcitabine plus carboplatin:
  • 1st line commenced with gemcitabine plus cisplatin or
  • 1st line chemotherapy commenced with gemcitabine plus carboplatin.
  1. The patient has completed at least 4 cycles and no more than 6 cycles of combination chemotherapy with gemcitabine plus cisplatin or gemcitabine plus carboplatin.
  2. The patient had a CT or MR scan after completing this chemotherapy and has been shown to have no evidence of progressive disease compared with the scans performed prior to chemotherapy and with any scans whilst on chemotherapy. Please enter below the response status of the tumour as assessed radiologically at the end of chemotherapy:
  • complete response to treatment at the end of 1st line chemotherapy or
  • partial response to treatment at the end of 1st line chemotherapy or
  • stable disease at the end of 1st line chemotherapy. Note: patients who have responded to chemotherapy as demonstrated on an interval scan during chemotherapy but whose scans at the end of chemotherapy show progressive disease are NOT eligible for maintenance avelumab therapy.
  1. The patient will commence treatment with avelumab within 4 to 10 weeks of receiving the last dose of chemotherapy.
  2. The patient has an ECOG performance status score of 0 or 1.
  3. Maintenance treatment with avelumab monotherapy will continue until disease progression or symptomatic deterioration or unacceptable toxicity or withdrawal of patient consent or after a maximum of 5 calendar years of avelumab treatment (as measured from cycle 1 day 1 of avelumab administration), whichever of these events occurs first.
  4. The patient has no symptomatically active brain metastases or leptomeningeal metastases.
  5. 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 (CTLA-4) antibody unless the patient has received maintenance avelumab via the EAMS program.
  6. Avelumab is being given as monotherapy.
  7. A formal medical review as to how treatment with avelumab is being tolerated and whether treatment with avelumab should continue or not will be scheduled to occur at least by the end of the first 8 weeks of treatment.
  8. Where a treatment break of more than 12 weeks beyond the expected 2-weekly cycle length is needed, I will complete a treatment break form to restart treatment, including an indication as appropriate if the patient had an extended break because of COVID 19.
  9. Avelumab will otherwise be used as set out in its Summary of Product Characteristics (SPC).

[NHS funded]{.badge .rounded-pill .bg-success} From: 10 June 2022

Form version:

CDF Managed Access: NA

NICE Technology Appraisal: TA788 (11 May 2022)

Current Form Version

Important

This is an older version of the form. To view the most up to date form follow this link