Spectrum, Hanmi Pharmaceutical’s U.S. partner, said Friday that it has rescinded the biologics license applications (BLA) for Rolontis, its neutropenia treatment, to accommodate the U.S. Food and Drug Administration’s request for more manufacturing data.
Rolontis is a biological drug with long-acting Granulocyte-Colony Stimulating Factor (G-CSF) that utilizes Hanmi’s Lapscovery, a proprietary platform technology.
The company plans to resubmit a revised BLA as soon as possible.
“The FDA did not cite concerns related to the pre-clinical and clinical modules of the BLA or the need for additional clinical studies,” the company said. “Spectrum’s decision to withdraw the BLA was the result of the company needing more time to provide certain additional manufacturing-related information, which was required before March 29, 2019, the day that the FDA’s initial 60-day review period ends.”
Spectrum Pharmaceuticals President and CEO Joe Turgeon said, “We are continuing to have productive discussions with the FDA and will deliver the additional information needed to support the application.”
The company remains confident in the Rolontis program and looks forward to a successful resubmission and its ultimate approval, he added.
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