European Commission approves Janssen-Cilag Balversa for adult patients with metastatic urothelial carcinoma
Overview
Belgium: Janssen-Cilag International NV, a Johnson & Johnson company, has announced that the European Commission (EC) has approved BALVERSA (erdafitinib) as a once-daily oral monotherapy for the treatment of adult patients with unresectable or metastatic urothelial carcinoma (mUC), harbouring susceptible FGFR3 genetic alterations who have previously received at least one line of therapy containing a PD-1 or PD-L1 inhibitor in the unresectable or metastatic treatment setting.
“Bladder cancer is one of Europe’s most common cancers and the need for innovative treatment options for people living with unresectable or metastatic urothelial carcinoma remains high,” said Yohann Loriot, M.D., Ph.D., Institut Gustave Roussy and University of Paris-Saclay, France.* “Erdafitinib is a novel, targeted therapy that has been shown to significantly improve overall and progression-free survival for patients with FGFR3 alterations, who, until now, have had limited options available.”
Europe has the highest rate of bladder cancer compared to all continents globally, with nearly a quarter of a million people diagnosed in 2022, representing a 10 percent increase from 2020. Urothelial carcinoma (UC) is the most common form of bladder cancer, and up to 20 percent of patients with mUC have FGFR alterations. Prognosis remains particularly poor for patients with mUC, with only eight percent of people diagnosed at a late metastatic stage surviving for five years.
“This important milestone emphasises the vital role of targeted therapies in addressing the unique genetic and disease characteristics of patients living with urothelial cancer, and reinforces our dedication to advancing cutting-edge, precision treatments in oncology,” said Henar Hevia, Ph.D., Senior Director, EMEA Therapeutic Area Lead, Oncology, Johnson & Johnson Innovative Medicine. “The approval of erdafitinib as a precision therapy further highlights the importance of FGFR testing for all patients with metastatic urothelial cancer, and the need for a multi-disciplinary team approach to optimise outcomes for each patient.”
In June 2023, based on the recommendation of the independent data safety monitoring committee, the THOR study was stopped following the interim efficacy analysis and all patients randomised to chemotherapy (docetaxel or vinflunine) were offered the opportunity to receive erdafitinib as crossover therapy. The results demonstrate median overall survival (OS) of over one year was achieved in patients receiving erdafitinib at the data cut-off, marking a significant improvement as compared to those in the chemotherapy arm (12.1 months vs. 7.8 months; hazard ratio [HR], 0.64; 95 percent confidence interval [CI], 0.44 to 0.93; P=0.0050). Treatment with erdafitinib also showed an improvement in median progression-free survival (PFS) compared to chemotherapy of 5.6 months versus 2.7 months (HR 0.58; 95 percent CI, 0.41 to 0.82; P=0.0002) and confirmed overall response rate (ORR) of 35.3 percent versus 8.5 percent.
“The EC approval of erdafitinib reflects our unwavering commitment to transforming outcomes for people living with unresectable or metastatic urothelial carcinoma,” said Kiran Patel, M.D., Vice President, Clinical Development, Solid Tumours, Johnson & Johnson Innovative Medicine. “We look forward to continuing our research and development efforts to bring new hope and improved outcomes to more patients in the future.”
In 2008, Janssen Pharmaceutica NV entered into an exclusive worldwide licence and collaboration agreement with Astex Therapeutics Limited to develop and commercialise erdafitinib.
Urothelial carcinoma (UC) starts in the innermost lining of the bladder. Almost all bladder cancers – more than 90 percent – are UCs. Up to one in five patients (20 percent) diagnosed with mUC have a fibroblast growth factor receptor (FGFR) genetic alteration. FGFRs 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. FGFRs play a key role in several biological processes, including tissue repair, inflammatory response and metabolism. Fusions or mutations in the genes that control FGFR (known as FGFR1–4 alterations) may lead to the development and progression of certain cancers by increasing tumour cell growth and survival. Patients with advanced UC, including FGFR-driven tumours, face a poor prognosis and the need for innovative therapies remains high. The five-year survival rate for patients with metastatic bladder cancer that has spread to distant parts of the body is currently 8 percent.
Also Read:Natco Pharma seeks USFDA nod for generic Erdafitinib Tablets
Speakers
