Indications such as refractory B-cell acute lymphocytic leukemia
Ministry of Food and Drug Safety, approval for JULIET·ELIANA research basis
[팜뉴스=김민건 기자] One-shot treatment that is a personalized treatment for one person and ends with a single treatment. The world’s first customized anti-cancer drug’Kymriah (Tisagen Rexel)’ can be officially used in Korea. Kimlia also acquired symbolism as the first treatment for advanced regenerative biopharmaceuticals, which was implemented in August last year.
Novartis Korea (CEO Josh Benugopal) announced on the 5th that it had obtained Kimlia’s permission from the Ministry of Food and Drug Safety.
The approved indication is ▲Recurrence or secondary recurrence after transplantation and subsequent relapsed or refractory B-cell acute lymphocytic leukemia (ALL) in children and young adult patients under 25 years of age ▲Relapsed or refractory after two or more systemic treatments Treatment of adult patients with diffuse large B-cell lymphoma (DLBCL).
Kimlia has become the first treatment of the Advanced Regenerative Bio Act (hereinafter referred to as the Chumba Act), which has been implemented since August last year for the purpose of’reinforcing and supporting biopharmaceutical quality and safety management.’
The Ministry of Food and Drug Safety said, “The quality, safety and effectiveness, and post-marketing safety management plan were thoroughly scientifically reviewed and evaluated according to the review criteria of the Advanced Renewable Bio Act.” Subject” explained. Accordingly, it is necessary to report the status of abnormal cases for 15 years from the date of administration and the results of long-term follow-up investigations every year from the date of initial sale to the KFDA.
◆Customized, manufacturing and storage for one person different from conventional treatments are also special
The CAR-T treatment is a method that is genetically recombined so that a chimeric antigen receptor (CAR) that recognizes a specific antigen of cancer cells can be expressed on the surface of T cells collected from a patient and then injected into the patient’s body again. .
Accordingly, Kimlia was developed as an autoimmune cell anticancer drug genetically modified to differentiate and remove CD19-expressing cells by introducing a transgene encoding CAR into the patient’s own T cells.
Novartis explained, “It is an anticancer drug that has all of the characteristics of cell, gene, and immunotherapy, and with only one treatment, patients with end-stage hematologic cancer who do not have other treatment options reach complete remission and show a continuous response.”
Kimlia, a high-tech biopharmaceutical, is made through a process such as ▲ cell collection ▲ cryopreservation and transportation ▲ production of personalized CAR-T cells ▲ injection back into the patient. This is because, unlike conventional drugs, it undergoes an advanced one-person customized process.
Novartis emphasized that “Kimria is customized for one patient through a secure system secured by professional manpower and medical institution training and certification for each country of introduction, and a specialized process of manufacturing plants,” said Novartis.
◆Kimria, approved based on JULIET·ELIANA research results
DLBCL and ALL are mostly treated with standard chemotherapy. A small minority of patients do not respond to treatment or experience recurrence. Among relapsed and refractory patients, the life expectancy is only about 6 months if secondary treatment such as hematopoietic stem cell transplantation fails.
Kimlia is expected to be a new anticancer drug that can expect long-term survival as well as return to daily life in patients with relapsed and refractory DLBCL and pALL who no longer have treatment options.
The Food and Drug Administration approved Kimlia based on the results of the JULIET and ELIANA studies, a phase 2 clinical study conducted by Novartis in collaboration with the University of Pennsylvania.
JULIET is a study of adults with relapsed and refractory DLBCL. After 3 months of administration, the overall response rate (ORR) was 53% (NE, 95% CI, 10.02-NE). Complete Remission (CR) was 39.1% (NE, 95% CI, NE). At 2 years of administration, the progression-free survival (PFS) was 33%.
ELIANA is a study of children with relapsed and refractory ALL. As a result of the study, 82% of patients (95% CI, 72%-90%) achieved CR or Complete Remission with incomplete blood count recovery (CRi) within 3 months of administration.
In 98% of patients who reached remission, minimal residual disease (MRD) was negative. At 6 months, the event-free survival (EFS) was 73% (95% CI, 60%-82%).
“Both clinical studies have demonstrated clinical efficacy, and median Duration of Response (mDOR) and median Overall Survival (mOS) were not reached,” Novartis said. “It disproves that the effect continues after the Ria treatment.”
Seong-soo Yoon, professor of hematology and oncology at Seoul National University Hospital, said, “Kimria is an innovative one-person customized treatment with a new mechanism that has not been in the history of anticancer drugs and one-shot treatment that ends with one treatment. “For patients with relapsed and refractory DLBCL who are only 6 months old, they can achieve complete remission with just one treatment and increase their survival rate,” he said.
Professor Yoon said, “Kimria is of great significance in that it not only improves survival time, but also helps patients and other family members return to their daily life by reducing patient visits to the hospital with one treatment.”
“Kimria is a miracle cure that can bring a new life to young ALL patients who were on the verge of death,” said Yoo Chul-ju, a professor at Yonsei University Severance Hospital. “After treatment, I have maintained a complete remission for 8 years until now, and I have been attending school and leading a normal daily life,” he said.
Kimlia, which was first approved by the US Food and Drug Administration (FDA) in August 2017, is being approved and used in 28 countries including Canada, Switzerland, Japan, Australia, and Germany.
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