AYVAKYT (avapritinib) - Gastrointestinal stromal tumours (GIST)

The clinical benefit of AYVAKYT 100, 200 and 300 mg film-coated tablets (avapritinib) remains substantial in this MA indication.

Considering:

• the not very robust quality of the initial evidence of its efficacy in terms of tumour response rate based on the results in a subgroup of patients (N = 38) from a non-comparative open-label phase 1 study and on external comparison with a historic cohort not scheduled in the protocol,
• the safety profile of avapritinib (numerous adverse effects, including, in particular, the onset of serious neurological disorders),
• uncertainties concerning its effect on the prognosis,
• the absence of a quality of life assessment,
• and the absence of any new clinical data liable to call into question the initial assessment,

the Committee deems that AYVAKYT (avapritinib) provides no clinical added value (CAV V) in the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumours (GIST) harbouring the platelet-derived growth factor receptor alpha (PDGFRA) D842V mutation.