Kyowa Kirin Announces Approval 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 May 17, 2024-Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE:4151, President and CEO: Masashi Miyamoto) reported that the company received an approval for partial change of approved indication of long-acting 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 hematopoietic stem cell transplantation*2 (the "indication") in Japan today (Press release, Kyowa Hakko Kirin, MAY 17, 2024, View Source [SID1234643425]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This approval 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 hematopoietic stem cell transplantation*4. By adding the indication of this sustained duration preparation to autologous hematopoietic stem cell transplantation, Kyowa Kirin expects to contribute to reducing burden on patients in hematopoietic stem cell transplantation therapy.

"We are highly pleased about this approval to expand the indication to autologous hematopoietic stem cell transplantation therapy," said Yuichi Kawasaki, Executive Officer, Director of Product Strategy Department of Strategy Division at Kyowa Kirin. "We will continue to deliver this product to patients undergoing hematopoietic stem cell transplantation therapy and contribute to this treatment 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.