Balversa targets FGFR3 genetic alterations and is approved as a second-line treatment for in adult patients with metastatic urothelial carcinoma.
The FDA has granted full approval for Johnson & Johnson’s 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.
Balversa was granted accelerated approval in April 2019. Balversa 3 mg has a list price of $19,848.65 for 56 tablets, according to Drugs.com. J&J offers a copay program of $5 a prescription, with a maximum benefit of $25,000 annually.
Urothelial 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 full approval was based on results from Cohort 1 of the open-label phase 3 THOR study, which assessed overall survival (OS) compared with chemotherapy in the second-line setting. Results from the study showed a 36% reduction in the risk of death with Balversa versus chemotherapy in patients previously treated with a PD-1 or PD-(L)1 inhibitor, with those in the Balversa arm living a median of more than four months longer.
Results from Cohort 1 were presented at the 2023 American Society of Clinical Oncology Annual Meeting (Abstract #LBA4619) in June 2023 and were published in the New England Journal of Medicine in November 2023.
The most common (>20%) adverse reactions were increased phosphate, nail disorders, stomatitis, diarrhea, decreased hemoglobin, decreased sodium, increased aspartate aminotransferase, fatigue, dry mouth, dry skin, decreased phosphate, decreased appetite, constipation, increased calcium, dry eye, increased potassium, alopecia, and central serous retinopathy.
Get the latest industry news, event updates, and more from Managed healthcare Executive.
Using the 'Pathway' Approach to Shorten the Time Between Cancer Diagnosis and Treatment
August 1st 2025In this episode of Tuning In to the C-Suite, Briana Contreras, editor with Managed Healthcare Executive spoke with Dr. Yuri Fesko, oncologist and vice president of Medical Affairs at Quest Diagnostics. In the conversation, Dr. Fesko addressed the ongoing issue of long gaps of times between receiving a diagnosis for a type of cancer and finally getting the treatment for it. Dr. Fesko shared the benefits a number of sectors receive when treating patients sooner and the steps to get there.
Listen
FDA Extends Review of Blenrep Combinations in Multiple Myeloma
August 1st 2025Last week, an FDA advisory committee against the risk-benefit profile of Blenrep in combination with other therapies. Regulators and reviewers were concerned about the ocular side effects and dosing and tolerability. The new action date is Oct. 23, 2025.
Read More
Sarepta to Pause Shipments of the Gene Therapy Elevidys
August 1st 2025Sarepta officials said the temporary halt in shipments was done to maintain a productive working relationship with regulators while they address a safety labeling update about the risk of acute liver disease related to Elevidys.
Read More