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In the context of Avapritinib & GIST (gastrointestinal stromal tumors) (PDGFRA m), the US FDA has approved avapritinib for adults with unresectable or metastatic GIST (gastrointestinal stromal tumors) (PDGFRA m) (PDGFRA exon 18 mutation, PDGFRA D842V mutation) (1, 2). This indication is mutation‑specific (PDGFRA exon 18, incl. D842V) and line‑agnostic (not restricted to a particular line of therapy), based largely on the NAVIGATOR trial showing very high response rates in this subgroup (3, 4).
In the EU, avapritinib is approved for adults with unresectable or metastatic GIST (gastrointestinal strom…