The first FGFR inhibitor for bladder cancer, Balversa (erdafitinib), will soon be launched in Korea.
According to industry sources on Monday, Janssen Korea is gearing up to release Balversa without reimbursement in late March.
Balversa is an FGFR (fibroblast growth factor receptor) inhibitor approved by the Ministry of Food and Drug Safety (MFDS) in November 2022 for treating adult patients with locally progressive or metastatic urothelial cancer with FGFR2 or FGFR3 mutations whose disease progressed during or after treatment with at least one chemotherapeutic agent, including platinum-based chemotherapeutic agents, or whose disease progressed within 12 months of neoadjuvant or adjuvant treatment with platinum-based chemotherapeutic agents.
Balversa gained traction as the first FGFR-targeted antineoplastic in bladder cancer. However, the changing treatment landscape at its approval in Korea made immediate clinical application difficult.
Balversa was evaluated for efficacy in patients who had previously received platinum-based chemotherapy in the approved clinical trials, as anti-PD-(L)1 immuno-oncology drugs, such as Bavencio (avelumab) maintenance therapy and Keytruda (pembrolizumab) monotherapy were already widely used in Korea at the time of its approval. Additional evidence was needed in patients with a history of immuno-oncology.
Initially approved in the U.S. and Korea based on response rates and duration of response in early clinical trials, Balversa recently demonstrated a prolonged overall survival (OS) benefit in patients treated with anti-PD-(L)1 immuno-oncology agents in the confirmatory phase 3 THOR study, which led to Janssen's transition of Balversa's approval to a formal license in the U.S. in January.
The U.S. Food and Drug Administration approved Balversa for treating patients with locally progressive or metastatic urothelial carcinoma with FGFR3 mutations whose disease progressed during or after at least one prior systemic therapy, with the addition that it is "not recommended for the treating patients eligible for PD-1 or PD-L1 inhibitor therapy but have not received such therapy previously.”
Janssen Korea also plans to submit THOR clinical data to the MFDS this year.
Since the THOR study included Korean patients, whether the Korean license will be scaled back to the U.S. version remains to be seen.
However, Janssen Korea has announced that Balversa will be available in Korea by the end of March. In addition, the company said it plans to launch a patient assistance program (PAP) to cover a portion of the drug's cost simultaneously with Balversa's launch, considering patients’ financial burdens due to its launch without reimbursement.