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ARZERRA (ofatumumab), monoclonal antibody
ONCOLOGY - New indication
Opinions on drugs -
Posted on
Jan 08 2016
Reason for request
Extension of indication
No clinical benefit demonstrated in the treatment of patients with chronic lymphocytic leukaemia who have not received prior therapy and who are not eligible for fludarabine-based therapy
- ARZERRA has Marketing Authorisation in the treatment of chronic lymphocytic leukaemia (CLL) in combination with chlorambucil or bendamustine in patients who have not received prior therapy and who are not eligible for fludarabine-based therapy.
- In one study, progression-free survival was 9 months longer in the ofatumumab+chlorambucil group than in the group treated with chlorambucil alone, which is a comparator of low relevance. No difference in overall survival was observed.
- Its efficacy in combination with bendamustine has been evaluated only in a non-comparative study.
Clinical Benefit
| Substantial |
- |
Clinical Added Value
| no clinical added value |
- |
Therapeutic use
|
- |
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