CAELYX (pegylated liposomal doxorubicin), cytotoxic agent - OVARIAN CANCER
ONCOLOGY - Focus
Opinions on drugs -
Posted on
Oct 13 2016
Reason for request
Re-assessment of the actual benefit and the improvement in actual benefit
No clinical benefit demonstrated in the treatment of advanced stage ovarian cancer
- CAELYX has Marketing Authorisation in advanced stage ovarian cancer in women after failure of first-line platinum-based chemotherapy.
- The new data presented in this re-assessment are not likely to demonstrate a relevant clinical benefit in the treatment of advanced stage ovarian cancer compared to:
- available monotherapies in case of relapse resistant to platinum salts,
- combinations used in case of relapse sensitive to platinum salts.
Clinical Benefit
Substantial |
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Clinical Added Value
no clinical added value |
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