Qarziba may be prescribed in general hospitals in KOR

The first drug covered through the approval-evaluation-negotiation linkage system

Lands at medical institutions in Korea including Samsung Medical Center, Seoul National University Hospital, Severance Hospital, and Asan Medical Center.

Reimbursement registered in December... shifts paradigm for maintenance therapy in neuroblastoma

Qarziba, an immunotherapy drug that targets neuroblastoma, may now be prescribed at general hospitals in Korea.

 

According to industry sources, Recordati Korea's immunotherapy drug for high-risk, recurrent, and refractory neuroblastoma, Qarziba Inj (dinutuximab beta), has passed the drug committees (DCs) of the ‘Big 5 general hospitals’ in Korea, including Samsung Medical Center, Seoul National University Hospital, Asan Medical Center, and Severance Hospital.

 

The company has been expanding the drug’s prescription in Korea since receiving reimbursement listing in December last year.

 

As the first drug covered through the approval-evaluation-negotiation linkage system, the drug was approved only 13 months after it was approved in Korea.

 

According to the Ministry of Health and Welfare notice, children from 12 months or older to less than 20 who have not received anti-GD2(disialoganglioside2) antibody treatment before with ▲high-risk neuroblastoma (INSS stage 4 disease or stage 2-3 and have MYCN gene amplification’ and have shown partial or better response to induction chemotherapy and have had hematopoietic stem cell transplant and initiated within 6 months of the transplant, and ▲recurrent or refractory neuroblastoma may receive Qarziba with reimbursement.

 

The drug demonstrated its effect through major pivotal studies, including the Phase III APN311-302 trial.

 

Main results showed that the 5-year event-free survival (EFS) rate for the Qarziba treatment group (378 patients) among high-risk neuroblastoma patients recieivng maintenance therapy was 57%, and the five-year overall survival (OS) rate was 64%, which was statistically significantly higher than that of the control group (466 patients) that did not receive Qarziba immunotherapy., which was 42% and 50%, respectively.

 

Ji-won Lee, a professor of the Department of Pediatric Hematology-Oncology at Samsung Medical Center, said, “This disease has a particularly poor prognosis and a large disease burden, so it is very important to implement an appropriate maintenance therapy that can minimize minimal residual disease (MRD) to prevent recurrence when treating neuroblastoma.

 

Qarziba has significantly improved the survival of patients with high-risk neuroblastoma as maintenance therapy compared to those that did not receive maintenance immunotherapy, shifting the treatment paradigm.” “Major overseas guidelines, such as the International Society of Pediatric Oncology Europe Neuroblastoma (SIOPEN) and the National Comprehensive Cancer Network (NCCN), have already recommended anti-GD2 antibodies such as Qarziba as standard maintenance immunotherapy for high-risk neuroblastoma,” said Jung-yoon Choi, Professor of the Department of Pediatrics at Seoul National University Children's Hospital.

 

”With the Korean patients also able to receive the global standard of care, I believe this will change the treatment environment in Korea.”