Obinutuzumab with bendamustine [OBIBEN1]

The treatment of follicular lymphoma refractory to rituximab where the following criteria apply:

  1. An application has been made by and the first cycle of systemic anti -cancer therapy will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
  2. The patient has a confirmed histological diagnosis of follicular lymphoma.
  3. The patient has been previously treated for follicular lymphoma with rituximab-containing chemotherapy (i.e. with induction rituximab-containing chemotherapy followed if appropriate by maintenance rituximab therapy) and that the patient has either progressed during rituximab-containing induction chemotherapy or progressed during or within 6 months of completing maintenance rituximabmonotherapy. Please indicate below whether the patient progressed during rituximab-containing induction chemotherapy or during or within 6 months of completing maintenance rituximab monotherapy:
  • The patient has either failed to respond to or progressed during rituximab-containing combination induction chemotherapy or
  • The patient has progressed during or within 6 months of completing maintenance single agent rituximab. If the patient progressed during or within 6 months of completing maintenance single agent rituximab, please indicate how many months since completion of previous induction rituximab-containing combination chemotherapy progression occurred: Please also indicate below whether the patient was originally treated with 1st line obinutuzumab-containing chemotherapy or not:
  • The patient was previously treated with 1st line obinutuzumab-containing chemotherapy or
  • The patient was not previously treated with 1st line obinituzumab-containing chemotherapy.
  1. The patient has not previously received treatment with bendamustine unless completed more than 2 years previously.
  2. A maximum of 6 cycles of the combination of obinutuzumab plus bendamustine should be used and followed in responding patients or in those with stable disease with maintenance single agent obinutuzumab once every 2 months for a maximum of 2 years or until disease progression (whichever occurs first).
  3. The patient has an ECOG performance status (PS) of 0 - 2.
  4. No planned treatment breaks of more than 6 weeks beyond the expected cycle length are allowed (to allow any toxicity of current therapy to settle or intercurrent comorbidities to improve).
  5. The licensed doses and frequencies of obinutuzumab and bendamustine will be used.

[NHS funded]{.badge .rounded-pill .bg-success} From: 11 August 2020

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NICE Technology Appraisal: TA629 (13 May 2020)

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