FDA approves Rolvedon for chemotherapy induced febrile neutropenia

The Food and Drug Administration (FDA) has approved Rolvedon (eflapegrastim-xnst) to decrease febrile neutropenia among adults with nonmyeloid malignancies receiving chemotherapy.

ROLVEDON™ (eflapegrastim-xnst) injection is a long-acting granulocyte colony-stimulating factor (G-CSF) with a novel formulation. Spectrum has received an indication to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia. ROLVEDON is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. The BLA for ROLVEDON was supported by data from two identically designed Phase 3, randomized, open-label, noninferiority clinical trials, ADVANCE and RECOVER, which evaluated the safety and efficacy of ROLVEDON in 643 early-stage breast cancer patients for the management of neutropenia due to myelosuppressive chemotherapy. In both studies, ROLVEDON demonstrated the pre-specified hypothesis of non-inferiority (NI) in mean duration of severe neutropenia (DSN) and a similar safety profile to pegfilgrastim. ROLVEDON also demonstrated non-inferiority to pegfilgrastim in the mean DSN across all four cycles (all NI p<0.0001) in both trials.

"This approval is a significant milestone for our development team and collaboration with Hanmi Pharmaceutical. On behalf of Spectrum, I would like to thank all of the patients, families, health care providers, and our own team members for bringing this goal to fruition."

"Our commercial team is in place and ready to engage key stakeholders immediately," said Erin Miller, Senior Vice President, Sales & Marketing of Spectrum Pharmaceuticals.

"Equipped with extensive long-acting growth factor market experience, customer connectivity and learnings from in-depth market research insights, we are ready to optimize the launch trajectory. We expect to have product available in the fourth quarter of 2022 following the fulfillment of customary, pre-launch regulatory requirements."

References:

1. Spectrum Pharmaceuticals receives FDA approval for Rolvedon™ (eflapegrastim-xnst) injection. News release. Spectrum Pharmaceuticals, Inc. September 9, 2022. Accessed September 12, 2022. https://www.businesswire.com/news/home/20220909005522/en/Spectrum-Pharmaceuticals-Receives-FDA-Approval-for-ROLVEDON™-eflapegrastim-xnst-Injection

2. Rolvedon. Package insert. Spectrum Pharmaceuticals, Inc; 2022. Accessed September 12, 2022. https://www.rolvedon.com/pdf/rolvedon-prescribing-information.pdf