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.
By reducing administrative burden and redesigning workflows around human needs, it creates space for what matters most: connection between clinicians and patients.
Shares of the company fell about 5 percent Monday following news that the FDA would review the drug avapritinib separately for two indications of gastrointestinal stromal tumor.