FDA Approves Rolvedon to Prevent Chemotherapy-related Infections

Rolvedon, which previously had the brand name Rolontis, is the first novel long-acting GCSF product approved in more than 20 years. Spectrum Pharmaceuticals expects it to be available in the fourth quarter.

The FDA has approved Spectrum Pharmaceuticals’ Rolvedon (eflapegrastim-xnst) injection to decrease infection in patients receiving myelosuppressive anti-cancer drugs. Previously named Rolontis, Rolvedon is indicated for adult patients with non-myeloid malignancies, but it is not intended for patients receiving hematopoietic stem cell transplantation.

Rolvedon is a long-acting granulocyte colony-stimulating factor (G-CSF) with a novel formulation. It comprises two protein components — an analog of G-CSF and an Fc antibody fragment — tethered by a flexible polyethylene-glycol linker. It uses the company’s LAPSCOVERY technology with a differentiated molecular structure.

The biologics license application was supported by data from two phase 3, 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, the therapy demonstrated the pre-specified hypothesis of non-inferiority n mean duration of severe neutropenia and a similar safety profile to pegfilgrastim.

In April 2022, the FDA accepted a resubmitted application for Rolvedon. In August 2021, the FDA had issued a complete response letter, citing deficiencies related to manufacturing. Spectrum executives said they have addressed the manufacturing deficiencies, and the re-inspection of the drug substance manufacturing facility has been completed by the FDA.