YERVOY (ipilimumab), monoclonal antibody

Substantial clinical benefit in monotherapy in the treatment of advanced melanoma in second-line and beyond in the absence of BRAF mutation and in third-line and beyond in the presence of BRAF mutation, but no clinical benefit demonstrated compared with usual management (chemotherapy and supportive care)

Insufficient clinical benefit to justify its inclusion on the list of reimbursable products in monotherapy in the treatment of advanced melanoma in other cases

• YERVOY has Marketing Authorisation in the treatment of adult patients with advanced (unresectable or metastatic) melanoma.
• Since the arrival of anti-PD-1 immunotherapy and so-called targeted therapies, monotherapy with YERVOY no longer has a role in the first-line treatment of advanced-stage melanoma, regardless of the BRAF status of the tumour, or in second-line treatment in the presence of a BRAF mutation.
• No methodologically admissible data document the efficacy and safety of YERVOY in the situations where it is now used (second-line and beyond in the absence of BRAF mutation and third-line and beyond in the presence of BRAF mutation).

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