Spectrum Pharmaceuticals Sees Delay from FDA on Eflapegrastim BLA


Spectrum Pharmaceuticals announced today that an inspection of the Hanmi Bioplant in South Korea will be necessary before the U.S. Food and Drug Administration (FDA) can approve its Biologics License Application (BLS) for ROLONTIS (eflapegrastim). Because of the COVID-19 pandemic, the FDA has not been able to conduct an inspection, and it has decided to defer action on the BLA until it can be completed.

"We are actively working with the FDA to find a way to expedite the plant inspection," said Joe Turgeon, president and CEO of Spectrum Pharmaceuticals. "The manufacturing facility is ready for inspection and we are eager to assist the FDA in completing their assessment as soon as possible."

ROLONTIS is a novel, long-acting granulocyte colony-stimulating factor (G-CSF). Spectrum Pharmaceuticals is looking at it as a potential treatment for neutropenia in patients receiving myelosuppressive anti-cancer drugs.

The BLA that Spectrum Pharmaceuticals is looking to advance is based on data from two Phase III clinical trials, ADVANCE and RECOVER. They evaluated the safety and efficacy of ROLONTIS in 643 early-stage breast cancer patients for the treatment of neutropenia. The product showed the pre-specified hypothesis of non-inferiority (NI) in duration of severe neutropenia (DSN), and it had a similar safety profile to pegfilgrastim.

Back in April, Spectrum Pharmaceuticals announced that it had dosed its first patient in a clinical trial to evaluate the administration of ROLONTIS on the same day as chemotherapy. The trial was aimed as evaluating the duration of severe neutropenia when administered at three different time points on the same day following standard chemotherapy.

“This study exemplifies our commitment to unlocking the full potential of ROLONTIS, the first novel biologic positioned to enter the G-CSF market since 2001,” Turgeon said at the time of the announcement. “A same day dosing option would be a unique and meaningful addition to the G-CSF category. We will continue to follow the science and explore ways to add value to patients and health care providers. The initiation of this study, despite the pandemic, highlights investigator’s interest and our team’s dedication.”

Approximately 45 patients were enrolled in the Phase I, open-label trial, with 1:1:1 randomization to three dosing time schedule arms. By June, the company had preclinical data from the study.

The duration of neutropenia in a rat model of chemotherapy induced neutropenia (CIN) was observed to be significantly shorter with ROLONTIS, compared to pegfilgrastim. This was also regardless of the timing of administration.

“These data in rats suggest that eflapegrastim administered at the time of chemotherapy, rather than waiting 24 hours, may be able to provide prophylaxis against chemotherapy induced neutropenia,” said Francois Lebel, M.D., chief medical officer of Spectrum Pharmaceuticals. “Based on these preclinical results, we recently initiated a Phase I clinical trial to compare the effect of same day dosing of eflapegrastim on the duration of neutropenia in patients with early-stage breast cancer when administered on the same day, at varying intervals following docetaxel and cyclophosphamide chemotherapy.”

Spectrum Pharmaceuticals presented its data at the American Association for Cancer Research Virtual Annual Meeting II. The company continues to focus on acquiring, developing and commercializing novel and targeted oncology therapies. Spectrum Pharmaceuticals has a track record of successfully executing across the biopharmaceutical business model. Its pipeline also includes poziotinib, an irreversible tyrosine kinase inhibitor that targets EGFR and HER2 mutations.


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