The drug, Ayvakit, showed a high overall response rate in patients with advanced systemic mastocytosis, a rare type of blood cancer with limited treatment options. Novartis' Rydapt has been approved for advanced SM for several years.
The agency on Thursday approved Ayvakit (avapritinib) for gastrointestinal stromal tumor, or GIST, that harbors a PDGFRa exon 18 mutation. Still, identifying patients could be the biggest challenge, an analyst wrote.
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