Spectrum Pharmaceuticals Receives FDA Approval for ROLVEDON™ (eflapegrastim-xnst) Injection

Date:
Sep 13, 2022

Spectrum Pharmaceuticals Receives FDA Approval for ROLVEDON™ (eflapegrastim-xnst) Injection


First novel Long-Acting GCSF (LA-GCSF) product approved in over 20 years

ROLVEDON™ developed using proprietary LAPSCOVERY™ technology with a differentiated molecular structure and proven safety and efficacy profile

Commercial team ready to launch with product available in the fourth quarter


Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced that the U.S. Food and Drug Administration (FDA) has approved ROLVEDON™ (eflapegrastim-xnst) injection 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’s approval marks Spectrum’s transformation to a commercial-stage company with the opportunity to compete in a $2 billion dollar market, and offers a unique value proposition,” said Tom Riga, President and Chief Executive Officer of Spectrum Pharmaceuticals. “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.”