Change of indication for G Lasta for the mobilization of hematopoietic stem cells into peripheral blood in allogeneic blood stem cell transplantation in Japan.- Kyowa Kirin.
Kyowa Kirin Co., Ltd. announced that the company received an approval for partial change of approved indication of G-Lasta [KRN125, generic name: pegfilgrastim (genetical recombination) , long-acting Granulocyte Colony-Stimulating Factor (G-CSF) preparation] according to the additional indication, dosage, and administration for the mobilization of hematopoietic stem cells into peripheral blood in allogeneic blood stem cell transplantation in Japan.
This approval is based on the results of the clinical trial conducted by Kyowa Kirin to evaluate the effect of G-Lasta on the mobilization of hematopoietic stem cells into peripheral blood in healthy volunteers.
G-Lasta is a long-acting G-CSF preparation licensed from Kirin Amgen and has been marketed in Japan since 2014 for decreasing the incidence of febrile neutropenia in cancer patients receiving chemotherapy. This approved sustained duration form is expected to contribute to reduce the burden of donor’s dosage, hospital visits and hospitalization. Kyowa Kirin also started a phase II clinical trial for mobilization of hematopoietic stem cells into peripheral blood for autologous blood stem cell transplantation in September 2021 in Japan.
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