Hematologic Disorders Archives - MPR

Hematologic Disorders

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FDA Panel Backs Pexidartinib for Rare Tumor, Votes Against Quizartinib for FLT3-ITD AML

The Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee recently voted on 2 investigational therapies being developed by Daiichi Sankyo: pexidartinib for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT), and quizartinib for the treatment of adults with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML).

Tibsovo Approved to Treat Newly Diagnosed AML With IDH1 Mutation

The FDA has expanded the indication for Tibsovo to include treatment of newly diagnosed acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test in adult patients who are ≥75 years old or who have comorbidities that preclude use of intensive induction chemotherapy.

Investigational Treatment for Hypereosinophilic Syndrome Granted Orphan Drug Status

The Food and Drug Administration (FDA) has granted Orphan Drug designation to dexpramipexole (Knopp Biosciences), an investigational treatment for hypereosinophilic syndrome (HES). HES is characterized by peripheral eosinophilia with evidence of organ involvement. Treatment depends on the severity of the condition and underlying cause; while steroid therapy is effective in most patients, high doses are…