Hanmi to apply to FDA for approval of new bio drug

Lee Han-soo  Published 2018.12.07  14:54  Updated 2018.12.07 17:40


Hanmi Pharmaceutical said Friday that it plans to submit a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) for Rolontis, its neutropenia treatment, by the end of this year.

Rolontis is a biological drug with long-acting Granulocyte-Colony Stimulating Factor (G-CSF) that utilizes Hanmi’s Lapscovery, a proprietary platform technology.

The announcement comes after the company presented the data on its second phase 3 clinical trial, which confirmed the efficacy of the drug at the 2018 San Antonio Breast Cancer Symposium (SABCS). Spectrum, its U.S. partner, presented the results of the study.

The second clinical trial, labeled RECOVER, demonstrated the drug’s non-inferiority for the duration of severe neutropenia (DSN) compared to Neulasta, its competing drug.

According to the announcement, the shorter, the shorter duration of the primary efficacy endpoint, the DSN ± SD (duration of severe neutropenia ± standard deviation), the better, the drug showed a mean of 0.31 ± 0.688 for the first cycle demonstrating non-inferiority compared to its competitor (0.39±0.949). The company added that it maintained the results during the four-week treatment cycle.

Also, the relative risk reduction rate was 14 percent higher for Rollontis than Neulasta.

For the second efficacy endpoint, the company noted that there was no statistically significant difference in the absolute value of absolute neutrophil count (ANC), depth of ANC nadir, recovery, and incidence of febrile neutropenia.

Drug-related side effects above grade 3 related to blood and bone pain in both groups were less than 2 percent in both groups.

“Despite available treatments, neutropenia remains a critical issue for patients undergoing chemotherapy that puts them at risk for developing life-threatening infections,” said Dr. Lee Schwartzberg, the lead investigator, and professor of medicine and division chief of hematology/oncology at the University of Tennessee Health Science Center.

The robust data from both Phase 3 studies demonstrate that Rolontis has the potential to be a valuable option in the management of neutropenia for patients undergoing treatment with chemotherapeutic agents, Schwartzberg added.

The RECOVER trial is the second Rolontis phase 3 study to meet the primary efficacy endpoint of non-inferiority in mean DSN. Results from ADVANCE, the first ROLONTIS Phase 3 study, were announced at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting and the Multinational Association in Supportive Care in Cancer Annual Meeting (MASCC) earlier this year.

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