Reason for request

Re-assessment of the actual benefit

High clinical benefit and minor clinical added value for first-line treatment of advanced melanoma

 

 

 

  • KEYTRUDA has been granted a marketing authorisation for monotherapy treatment of adults suffering from advanced melanoma.

  • In B-RAF mutation-negative cases, similar to nivolumab (OPDIVO), it is recommended as a first-line treatment.

  • In cases of B-RAF mutation, similar to nivolumab (OPDIVO), its role as an alternative to targeted therapies is currently the subject of debate, particularly in relation to the profile of patients suitable for receiving either of these two therapies as a first-line treatment.

  • The new data, based on the follow-up from 2 previously assessed studies, do not shed new light on the assessment of the effective quantity of this medicinal product in the indication and at the marketing authorisation dosage.

 

 


Clinical Benefit

Unspecified

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Clinical Added Value

minor

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Évaluation des médicaments