Spectrum Says Its Novel G-CSF Drug Will Be Reviewed by FDA

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In late December, Spectrum Pharmaceuticals announced that the FDA has accepted for review a Biologics License Application for eflapegrastim, a novel drug that could, if approved, compete with existing granulocyte colony-stimulating factor (G-CSF) therapies and their biosimilars.

In late December, Spectrum Pharmaceuticals announced that the FDA has accepted for review a Biologics License Application (BLA) for eflapegrastim, a novel drug that could, if approved, compete with existing granulocyte colony-stimulating factor (G-CSF) therapies and their biosimilars.

Eflapegrastim, which the company hopes to sell under the brand name Rolontis, comprises 2 proteins: an analog of G-CSF and an Fc antibody fragment. These components are joined by a polyethylene-glycol linker. According to the company, the Fc fragment is thought to interact with FcRn—expressed in endothelial cells and bone marrow—and to prolong the drug’s retention in these tissues.

“If approved, Rolontis could be the first novel [G-CSF] available to healthcare providers in over 15 years,” said the company’s chief executive officer, Joe Turgeon, in a statement. “We have confidence in the future of Rolontis and are looking forward to potentially competing in this multibillion-dollar market.”

The company expects a decision from the FDA by October 24, 2020.

The drug was studied in comparison with pegfilgrastim a phase 3, randomized, open-label trial in 237 patients with breast cancer who were receiving chemotherapy. Patients were randomized to receive either the investigational drug (n = 118) or pegfilgrastim (n = 119), and the primary end point was the duration of severe neutropenia in cycle 1 of chemotherapy as measured by absolute neutrophil count.

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