FDAapproves avapritinib for the treatment of adults with indolent systemic mastocytosis.
, 222 patients with mild to moderate indolent, systemic mastocytosis were randomly assigned in a 2:1 ratio to receive either avapritinib 25 mg once daily plus best supportive care or placebo plus best supportive care., revealed that patients who received avapritinib experienced significantly greater improvements in total symptom scores at 24 weeks .
Most adverse reactions were mild to moderate in severity and included eye edema, dizziness, peripheral edema, and flushing. Fewer than 1% of patients discontinued treatment because of serious adverse reactions. "People with indolent systemic mastocytosis are significantly impacted by their disease symptoms, and many individuals self-isolate at home to protect against unpredictable external triggers," Judith Kain Emmel, board chair of the Mast Cell Disease Society, said in the company press release."Today's approval is a historic moment for the [systemic mastocytosis] community and offers new hope for patients and their families.
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