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YERVOY (ipilimumab), monoclonal antibody

ONCOLOGY - New indication
Opinions on drugs - Posted on Jan 21 2015

Reason for request

Extension of indication

No clinical added value demonstrated as a first-line treatment of advanced melanoma in adults when compared with existing therapeutic strategies

 

  • YERVOY now has Marketing Authorisation as first-line treatment for advanced (unresectable or metastatic) melanoma in adult patients.
  • In view of the low level of evidence of the submitted studies, YERVOY provided no demonstrable clinical benefit compared with the existing first-line therapeutic strategy for the treatment of advanced melanoma in adults.

Clinical Benefit

Moderate

moderate as a first-line treatment for adult patients with advanced (unresectable or metastatic) melanoma, without a B-RAF mutation and in patients with slow progression, good general condition and a life expectancy greater than 3 months.


Clinical Added Value

no clinical added value

In the absence of demonstrated efficacy or safety greater than the existing therapeutic strategy for first-line treatment of advanced melanoma in adults, YERVOY does not provide any improvement in actual benefit (IAB V, non‑existent)