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Janssen Seeks Full Approval for Balversa for Urothelial Carcinoma


The FDA granted accelerated approval to Balversa in 2019. Patients who received Balversa in Janssen’s confirmatory study achieved a median overall survival of more than one year. It reduced the risk of death by 36%.

Janssen has submitted a supplemental new drug application (sNDA) for full approval of Balversa (erdafitinib) to treat patients with metastatic urothelial carcinoma. Balversa is a kinase inhibitor for adult patients who have susceptible fibroblast growth factor receptor (FGFR)3 genetic alterations and who progressed during or following treatment.

Urothelial carcinoma, also known as transitional cell carcinoma, is the most common form of bladder cancer, representing more than 90% of all bladder cancers. About 20% of patients diagnosed with metastatic urothelial carcinoma have an FGFR genetic alteration. The five-year survival rate for patients with Stage IV metastatic bladder cancer is 8%.

The FDA had granted accelerated approval for Balversa for these patients in 2019. Balversa 3 mg has a list price of $19,848.65 for 56 tablets, according to Drugs.com. It is administered through CVS Specialty. Janssen offers a copay program of $5 a prescription, with a maximum benefit of $25,000 annually.

The sNDA is based upon data from Cohort 1 of the phase 3 THOR study, which met its primary endpoint of overall survival (OS). Patients who received Balversa achieved a median overall survival of more than one year, and Balversa reduced the risk of death by 36%. These data were presented at the June 2023 American Society of Clinical Oncology (ASCO) Annual Meeting.

Results from the interim analysis of Cohort 1 included data for 266 patients where 136 patients were assigned to Balversa and 130 were randomized to chemotherapy. At the data cutoff on Jan. 15, 2023, overall survival in patients who received Balversa was 12.1 months compared with 7.8 months in patients who received chemotherapy.

Serious treatment-related adverse events (TRAEs) were observed in 13.3% of patients who received Balversa and 24.1% of patients who received chemotherapy; 8.1% of patients in the Balversa arm discontinued because of adverse events and 13.4% of patients who received chemotherapy discontinued treatment.

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