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YTTRIGA (yttrium [90Y]), radiopharmaceutical product for therapeutic use
DIAGNOSTIC PRODUCT - New medicinal product
Opinions on drugs -
Posted on
Jan 22 2015
Reason for request
Inclusion
Improvement in treatment by YTTRIGA on its own cannot be assessed.
- YTTRIGA has Marketing Authorisation as a radiopharmaceutical precursor intended for use only for the labelling of vector molecules, which have been specifically developed and authorised for labelling with this radionuclide.
- Yttrium chloride (90Y), the active ingredient of YTTRIGA is a radiopharmaceutical medicinal product for use in radioimmunotherapy. Its place in the strategy depends on the vector molecule.
- In the absence of YTTRIGA/vector molecule versus YTRACIS/vector molecule comparison, the improvement that it brings cannot be assessed.
Clinical Benefit
| Unspecified |
Given that:
- YTTRIGA, being a radiopharmaceutical precursor, cannot be evaluated except in combination with a vector molecule specially developed for the treatment of a disease by targeted radiotherapy,
- there are no data that would permit evaluation of this combination;
the Committee considers that the actual benefit of YTTRIGA cannot be assessed. |
Clinical Added Value
| Unspecified |
In the current state of the data and in the absence of comparative studies of YTTRIGA/vector molecule versus YTRACIS/vector molecule, the improvement in actual benefit due to YTTRIGA by comparison with YTRACIS cannot be assessed. |
