FDA Approves First Long Acting G-CSF – Rolvedon

The FDA recently approved a BLA for Rolvedon (eflapegrastim-xnst) from Spectrum Pharmaceuticals. It has 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.

Rolvedon is a recombinant human granulocyte-colony stimulating factor (G‐CSF). Spectrum said the FDA action marks the first novel long-acting GCSF (LA-GCSF) product approval in over 20 years.

Spectrum did not release pricing for the new therapy. Although it is a long-acting formulation, market pick-up remains to be seen given the range of available colony stimulation options. The company plans to commercially launch the injection in Q4.

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FDA Approves Eflapegrastim for Chemo-Induced Neutropenia

by Chris Ryan

The FDA has approved 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.

The FDA has approved 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.1

The approval was supported by data from the phase 3 ADVANCE (NCT02643420) and RECOVER (NCT02953340) trials, where eflapegrastim demonstrated the pre-specified hypothesis of non-inferiority vs pegfilgrastim (Neulasta) in mean duration of severe neutropenia with a similar safety profile to pegfilgrastim.

“Eflapegrastim’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,” Tom Riga, president and chief executive officer of Spectrum Pharmaceuticals, stated in a news release. “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.”

The ADVANCE and RECOVER trials both evaluated the efficacy and safety of eflapegrastim vs pegfilgrastim in the management of neutropenia in patients with breast cancer receiving docetaxel and cyclophosphamide.

ADVANCE and RECOVER enrolled patients with early-stage breast cancer who were randomly assigned to fixed‐dose eflapegrastim at 13.2 mg/0.6 mL(3.6 mg G‐CSF) or standard pegfilgrastim (6 mg G‐CSF) following standard docetaxel plus cyclophosphamide chemotherapy for 4 cycles.3,4 Subcutaneous injections of eflapegrastim or pegfilgrastim were administered on day 2 of each cycle, approximately 24 hours after chemotherapy. Patients received 75 mg/m2 of intravenous (IV) docetaxel and 600 mg/m2 of IV cyclophosphamide on day 1 of every 21-day cycle.

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