Eye on Pharma: Withdrawn BLA for Novel G-CSF Expected to Compete With Pegfilgrastim

Spectrum Pharmaceuticals has withdrawn its Biologics License Application (BLA) for eflapegrastim, a granulocyte colony-stimulating factor (G-CSF) therapy that the company had hoped to sell under the brand name Rolontis.

According to the drug maker, the FDA requested additional manufacturing information, though the agency did not ask for further clinical studies. The company said that it needs more time to provide some of the requested information to the agency, and that it would be unlikely to be able to meet the FDA’s request prior to the end of the initial review period.

Spectrum says that it plans to resubmit a revised BLA for eflapegrastim in the future. “We are continuing to have productive discussions with the FDA and will deliver the additional information needed to support the application,” Joe Turgeon, president and chief executive officer of Spectrum, said in a statement. “We remain confident in the Rolontis program and look forward to a successful resubmission and its ultimate approval.”

The drug had been expected to compete with pegfilgrastim (Neulasta) and its biosimilars (the recently FDA-approved and US-launched Fulphila and Udenyca) for market share; the long-acting G-CSF agent has demonstrated a 2- to 3-fold increase in area under the time‐concentration curve for absolute neutrophil count versus pegfilgrastim when administered at similar doses, and the proposed drug also demonstrated comparable efficacy compared with pegfilgrastim in an open-label study in patients with breast cancer who were receiving docetaxel and cyclophosphamide. Finally, no new safety concerns were noted during the clinical program.

However, now that biosimilars of pegfilgrastim are entering the marketplace and are competing with Neulasta, it remains to be seen whether there will be an appetite for a costly brand-name G-CSF agent among a field of less expensive biosimilar options.