Spectrum, Hanmi Pharmaceutical’s U.S. partner, said Friday that it has resubmitted the biologics license applications (BLA) for Rolontis, its neutropenia treatment, to the U.S. Food and Drug Administration.
|Hanmi headquarters in Bangi-dong, eastern Seoul.|
Rolontis is a biological drug with long-acting granulocyte-colony stimulating factor (G-CSF) that utilizes Hanmi’s Lapscovery, a proprietary platform technology.
The resubmission came after the company rescinded its initial BLA for the drug to accommodate the FDA’s request for more chemistry, manufacturing and control data in March. This time around, the company revised its BLA based on the data from its two clinical phase 3 trials – ADVANCE and RECOVER.
In these trials, Spectrum confirmed the safety and efficacy of Rolontis in 643 early breast cancer patients who developed neutropenia after receiving myelosuppressive chemotherapy. Both experiments also demonstrated the non-inferiority of the duration of severe neutropenia and the superior relative risk reduction for Rolontis compared to pegfilgrastim for a total of four treatment cycles.
“The company believes that Rolontis will become the most innovative treatment for neutropenia in the future,” Spectrum Pharmaceuticals President and CEO Joe Turgeon said. “If approved by the FDA, the company expects to become a competitive player in a multi-billion dollar market.”
Hanmi Pharmaceutical Kwon Se-chang also said, “Of the drug’s that use our proprietary Lapscovery technology, Rolontis is the closest one to global commercialization. We are confident that the success of Rolontis will allow Hanmi to move faster toward becoming a pharmaceutical powerhouse.”
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