The FDA has approved Nucala (mepolizumab; GlaxoSmithKline) for the treatment of hypereosinophilic syndrome (HES) for 6 months or longer without another identifiable non-blood related cause of the disease in patients aged 12 years and older.
The Food and Drug Administration (FDA) has approved Nyvepria™ (pegfilgrastim-apgf; Pfizer), a biosimilar to Neulasta (pegfilgrastim; Amgen). Nyvepria, a leukocyte growth factor, is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia. The approval…
The FDA previously granted Fast Track and Orphan Drug designations to mepolizumab for the treatment of HES.
The FDA has approved Ziextenzo (pegfilgrastim-bmez; Sandoz), a biosimilar to Neulasta.
The FDA has granted BBT-059 (Bolder Technology) Orphan Drug designation for the treatment of acute radiation syndrome.
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…
A recent report published in the American Journal of Case Reports describes a rare case of drug reaction with eosinophilia and systemic symptoms (DRESS)-induced agranulocytosis in a patient treated with the beta-lactam antibiotic oxacillin.
The BLA was supported by data from two Phase 3 trials (ADVANCE and RECOVER).
The FDA approval was supported by data from the Phase 1b M14-358 dose escalation and expansion study and the Phase 1/2 M14-387 dose escalation and expansion study that included patients with newly-diagnosed AML, including those who were ineligible for intensive induction chemotherapy.
The treatment was evaluated in the Phase 2 BRIGHT 1003 trial which randomized newly-diagnosed AML patients to receive Daurismo + LDAC (N=77) or LDAC alone (N=38) until disease progression or unacceptable toxicity.
