Reason for request

Extension of indication

Moderate clinical added value relative to dacarbazine as a monotherapy in advanced or metastatic unresectable liposarcoma in patients who have received prior anthracycline containing chemotherapy.

 

  • HALAVEN now has Marketing Authorisation in the treatment of “patients with unresectable liposarcoma who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease”
  • It improves overall survival relative to dacarbazine with an uncertainty in the precise estimation of the extent of the effect in the subgroup of patients covered by the Marketing Authorisation and having liposarcoma.
  • No comparison is available with YONDELIS (trabectedin).
  • The frequency of grade 3 or 4 adverse events was higher in the eribulin arm (62.8%) than in the dacarbazine arm (54.9%), notably due to a higher proportion of neutropenia, peripheral neuropathies and infections.

 

 


Clinical Benefit

Substantial

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Clinical Added Value

moderate

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