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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