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MUPHORAN (fotemustine), nitrosourea

Opinions on drugs - Posted on Feb 14 2019

Reason for request

Re-assessment of the actual benefit and of the improvement in actual benefit

Moderate clinical benefit in the alternative treatment of advanced stage melanoma, following resistance to immunotherapies and/or to targeted therapies according to B-RAF status, but no demonstrated clinical advantage in the management of advanced stage melanoma.


Insufficient clinical benefit to justify reimbursement in other situations, particularly in first-line.


  • MUPHORAN has been granted a marketing authorisation for the treatment of disseminated malignant melanoma (including for cerebral locations).

  • In the treatment of advanced stage melanoma, immunotherapy and anti-B-RAF agents, either alone or in combination with anti-MEK agents, are more effective than chemotherapy (including dacarbazine) in terms of progression-free survival and/or overall survival.

  • The role of chemotherapy is now restricted to the last line of treatment. Fotemustine represents an alternative to dacarbazine, particularly in the event of brain metastases, in the alternative treatment of advanced stage melanoma.


Clinical Benefit




Clinical Added Value

no clinical added value


Not applicable