FDA approves Rolvedon to reduce infection incidence when taking certain anticancer drugs
The FDA approved eflapegrastim-xnst injection to reduce incidence of infection, as manifested by febrile neutropenia, in adults with nonmyeloid malignancies taking certain anticancer drugs, according to a company-issued press release.
The approval of eflapegrastim-xnst (Spectrum Pharmaceuticals), a long-active granulocyte colony-stimulating factor with a novel formulation, applies to patients who receive myelosuppressive treatments linked to clinically significant incidence of febrile neutropenia.
Data from two randomized phase 3 noninferiority clinical trials supported the biologics license application for eflapegrastim-xnst.
The ADVANCE and RECOVER trials investigated the safety and efficacy of the drug for the management of neutropenia among 643 patients with early-stage breast cancer who received myelosuppressive chemotherapy. In the trials, eflapegrastim-xnst showed noninferiority to pegfilgrastim in mean duration of severe neutropenia across all four treatment cycles (P < 0.0001) with a similar safety profile.
The company expects the product to be available in the fourth quarter of this year, according to the release.
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