Kyowa Kirin Announces Application for Partial Change of Approved Indication of G-Lasta® for the Mobilization of Hematopoietic Stem Cells into Peripheral Blood for Autologous Blood Stem Cell Transplantation in Japan

On July 24, 2023-Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE:4151, President and CEO: Masashi Miyamoto) reported that the company has filed an application for partial change of approved indication of the sustained duration form of G-CSF(Granulocyte-Colony Stimulating Factor)*1 product G-Lasta [KRN125, generic name: pegfilgrastim (genetical recombination)] for the mobilization of hematopoietic stem cells into peripheral blood in autologous blood stem cell transplantation*2 (the "indication") in Japan today (Press release, Kyowa Hakko Kirin, JUL 24, 2023, View Source [SID1234633392]).

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This application is based on the results of a clinical trial conducted by Kyowa Kirin to evaluate the effect of G-Lasta on the mobilization of hematopoietic stem cells into peripheral blood in patients with multiple myeloma and malignant lymphoma.

G-Lasta is a long-acting G-CSF preparation licensed from Amgen K-A and has been marketed in Japan since 2014 for decreasing the incidence of febrile neutropenia*3 in patients receiving cancer chemotherapy. In February 2022, Kyowa Kirin received an approval for the indication of G-Lasta for the mobilization of hematopoietic stem cells into peripheral blood in allogeneic blood stem cell transplantation*4. By adding the indication of this sustained duration preparation to autologous blood stem cell transplantation, Kyowa Kirin expects to contribute to reducing burden on patients in hematopoietic stem cell transplantation therapy.

"We are very delighted with this application to add the indication to autologous blood stem cell transplantation therapy," said Yuichi Kawasaki, Executive Officer, Director of Product Strategy Department of Strategy Division at Kyowa Kirin. "

We will continue to strive to deliver this product to patients and provide new value to the blood stem cell transplantation therapy area." The Kyowa Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies.