Spectrum Gets FDA Nod For Febrile Neutropenia Candidate, Sees Commercial Launch In Q4 2022

The U.S. Food and Drug Administration (FDA) has approved Spectrum Pharmaceuticals’ SPPI lead asset ROLVEDON (eflapegrastim-xnst) injection to decrease the incidence of infection, as manifested by febrile neutropenia.

ROLVEDON (eflapegrastim-xnst) injection is a long-acting granulocyte colony-stimulating factor (G-CSF) with a novel formulation

The company 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.

The regulatory submission was supported by data from ADVANCE and RECOVER, two Phase 3 clinical trials 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.

Tom Riga, President and Chief Executive Officer, commented: "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. This approval is a significant milestone for our development team and collaboration with Hanmi Pharmaceutical.”

The company expects to launch with product available in the fourth quarter of 2022.

Price Target : Spectrum shares are trading around 12 percent higher at $1.45 on Friday during after-hours session.