MUPHORAN (fotemustine), nitrosourea
Reason for request
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 Added Value
|no clinical added value||