Reason for request

Re-assessment of the IAB

-


Clinical Benefit

Substantial

the actual benefit of BEROMUN is substantial in the indication "treatment of soft tissue sarcoma of the limbs :

- for subsequent removal of the tumour so as to prevent or delay amputation ;

- in the palliative situation, for irresectable soft tissue sarcoma. "


Clinical Added Value

minor

In view of the available data, the Committee considers that the BEROMUN/melphalan combination provides : 

- a minor IAB (level  IV) in the treatment of soft tissue sarcoma of the limbs for  subsequent removal of the tumour, so as to prevent or delay amputation,

- a minor IAB (level IV) in irresectable soft tissue sarcoma.