FDA approves Rolvedon to reduce infection incidence when taking certain anticancer drugs
Click Here to Manage Email Alerts
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.
Read more about
Click Here to Manage Email Alerts