Reason for request

Extension of Inclusion

Minor improvement in the treatment of locally advanced, inoperable or metastatic, differentiated thyroid carcinoma refractory to radioactive iodine

 

  • NEXAVAR has Marketing Authorisation in the treatment of progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma refractory to radioactive iodine. 
  • Given the increase in progression-free survival but lack of demonstrated impact on overall survival, the safety profile and deterioration in quality of life, the selection of patients in whom systemic treatment with NEXAVAR is justified must be based on various criteria, including maximum size of metastases (1-2 cm), symptoms associated with the disease and rate of progression.

Clinical Benefit

Substantial

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Clinical Added Value

minor

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Therapeutic use

-

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