Balversa may be prescribed at general hospitals in Korea

The new bladder cancer drug lands in Big 5 tertiary hospitals in Korea

With SMC and SNUH being the last of the 5 to generate prescription codes

Company applies for reimbursement 2 years after domestic approval

The new bladder cancer drug Balversa may now be prescribed in Korea’s Big 5 tertiary hospitals in Korea.

 

According to industry sources, Janssen Korea's FGFR-inhibiting urothelial carcinoma (bladder cancer) drug Balversa (erdafitinib) recently passed the drug committees (DCs) of tertiary hospitals including Samsung Medical Center, Seoul National University Hospital, Seoul St.

 

Mary's Hospital, Asan Medical Center, and Sinchon Severance Hospital.

 

In addition, the drug’s prescription codes have been generated at major medical institutions across the country, including Kangnam Sacred Heart Hospital, GangNeung Asan Hospital, Hallym University Kangnam Sacred Heart Hospital, National Cancer Center, Keimyung National University Hospital, Ulsan National University Hospital, Korea Cancer Center Hospital, and Chonnam National University Hwasun Hospital.

 

Balversa was approved by the Ministry of Food and Drug Safety in January 2022, but it is still not reimbursed in Korea.

 

But expectations have been rising since Janssen submitted a reimbursement application for Balversa at the end of last year.

 

As such, it remains to be seen if Balversa will be reimbursed by the end of the year and become a viable treatment option in Korea.

 

Specifically, the drug is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with FGFR2 or FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy, which includes platinum-based chemotherapy, or whose disease has progressed within 12 months of neoadjuvant or adjuvant treatment with platinum-based chemotherapy.

 

However, the approval of PD-1 and PD-L1-directed immuno-oncology agents in the first- and second-line settings that followed Balversa’s approval led to the need for Balversa to demonstrate efficacy in patients who previously received these agents.

 

The situation was addressed with the publication of Balversa’s Phase III THOR trial study, which demonstrated a prolonged overall survival (OS) benefit with Balversa over chemotherapy in patients with metastatic urothelial carcinoma with FGFR3/2 gene alterations whose disease progressed after first-line treatment with immuno-oncology agents.

 

In the study, Balversa prolonged overall survival (OS) compared with chemotherapy in patients with metastatic urothelial carcinoma.

 

Results showed that over a median follow-up of 15.9 months, the mOS was 12.1 months in the Balversa arm, reducing the risk of death by 36% compared with the 7.8 months in the chemotherapy arm.

 

Based on these findings, the U.S.

 

Food and Drug Administration granted Balversa formal approval in January, but with a more restricted indication than originally approved.

 

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) also recently recommended expanding Balversa’s indication.

 

Janssen Korea has additionally submitted the results from the THOR study to Korea’s Ministry of Food and Drug Safety.

 

Therefore, the company may start the reimbursement progress in earnest for Balversa in the second half of the year.

 

Therefore, it remains to be seen whether Balversa will be able to go beyond landing in medical institutions and gain insurance reimbursement in Korea.

 

Meanwhile, bladder cancer is one major cancer that has lacked a targeted therapy option.

 

Balversa is the first targeted anti-cancer drug for bladder cancer with a novel mechanism of action that inhibits fibroblast growth factor receptor (FGFR).

 

FGFR is a biomarker involved in cancer cell growth that is associated with various cancers.

 

FGFR mutations are particularly common in bladder cancer, with 20 to 30% of patients carrying mutations.