January 21, 2024: The FDA has granted full approval for Janssen Biotech’s Balversa drug to treat metastatic bladder cancer after clinical trials showed “significant” improvement in overall survival rates.
The oral drug erdafitinib branded as Balversa, by the wholly-owned subsidiary of Johnson & Johnson, is effective against advanced bladder cancer with selective genetic alterations and should be administered prior therapies.
A study was conducted on 266 patients to measure overall survival, investigator-assessed progression-free survival and objective response rate.
“Statistically significant improvements in OS, PFS, and ORR were demonstrated for erdafitinib compared with chemotherapy,” according to an FDA statement.
Metastatic bladder cancer occurs when the cancer has spread from where it started in your bladder to another part of the body. It is sometimes called advanced bladder cancer. Doctors also use the terms primary and secondary cancer.
Most common form
Metastatic urothelial carcinoma (mUC), also known as transitional cell carcinoma, starts in the innermost lining of the bladder. It is the most common form of bladder cancer, representing more than 90% of all bladder cancers.
The metastatic or unresectable disease is identified in approximately 20% of patients presenting with urothelial cancer, and an estimated five to eight per cent of all bladder cancers.
About one in five patients (20%) diagnosed with mUC have a genetic alteration. Fibroblast growth factor receptors are a family of receptor tyrosine kinases that can be activated by genetic alterations in a variety of tumour types, and these alterations may lead to increased tumour cell growth and survival.
The five-year survival rate for patients with stage IV metastatic bladder cancer that has spread to distant parts of the body is currently eight per cent, according to the company statement.
“This FDA action converts the April 2019 accelerated approval of Balversa to a full approval based on the clinical and overall survival benefit observed in the Phase 3,” study, according to a Janssen statement.
Johnson & Johnson is offering the drug and associated patient services through a single-source speciality pharmacy provider, US Bioservices.
Balversa received Breakthrough Therapy Designation from the USFDA in 2018 and received accelerated approval in 2019 for the treatment of adults with locally advanced or mUC which has susceptible genetic alterations.
The company submitted a marketing authorization application to the European Medicines Agency in September 2023 for Balversa as a treatment for adult patients.