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ODOMZO (sonidegib), Hedgehog inhibitor
ONCOLOGY - New medicinal product
Opinions on drugs -
Posted on
Jul 12 2017
Reason for request
Inclusion
Minor clinical added value in the treatment of locally-advanced basal cell carcinoma not eligible for curative surgery or radiotherapy.
- ODOMZO has marketing authorisation in the treatment of locally-advanced basal cell carcinoma (BCC) not eligible for curative surgery or radiotherapy.
- The only available data result from a subgroup of a phase II non-comparative study that included two patient profiles: locally-advanced BCC and metastatic BCC. The efficacy results are based on the overall response rate (complete or partial response)
- ODOMZO is an alternative to ERIVEDGE in this indication. There are no comparative studies.
Clinical Benefit
| Substantial |
- |
Clinical Added Value
| minor |
- |
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