Obinutuzumab [OBI2]

Obinutuzumab in combination with chlorambucil for untreated chronic lymphocytic leukaemia where the following criteria have been met:

  1. This application is being made by and the 1st cycle of systemic anti cancer therapy with obinutuzumab plus chlorambucil 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 pathological diagnosis of chronic lymphocytic leukaemia.
  3. The patient has documented CD20+ chronic lymphocytic leukaemia
  4. The patient has NOT been previously treated for chronic lymphocytic leukaemia and has comorbidities that make full‑dose fludarabine‑based therapy and bendamustine‑based therapy unsuitable for them, e.g. people who have comorbidities such as impaired renal function, hypertension or diabetes
  5. A maximum of 6 cycles of the combination of obinutuzumab plus chlorambucil should be used
  6. The patient has a performance status (PS) of 0 - 2.
  7. 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).* *Requests for continuation of treatment after unplanned treatment breaks over this duration should be made via the treatment break approval process.
  8. The licensed doses and frequencies of obinutuzumab and chlorambucil will be used.

[NHS funded]{.badge .rounded-pill .bg-success} From: 31 August 2015

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NICE Technology Appraisal: TA343 (02 June 2015)

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