A supplemental New Drug Application (sNDA) has been submitted to the U.S. Food and Drug Administration for the approval of Balversa (erdafitinib) to treat patients with locally advanced or metastatic urothelial carcinoma with FGFR3 or FGFR2 gene alterations, and progressed on a prior checkpoint inhibitor or within 12 months of pre- or post-surgical therapy, according to a press release from Janssen, the manufacturer of the drug.
Janssen hopes the recent sNDA submission of Balversa will meet all regulatory requirements to ensure the benefits of Balversa. The data included in the submission is from Cohort 1 of the phase 3 THOR study, that measured whether Balversa was effective and safe enough for patients to be treated with.
Overall, the medication met the criteria, and successfully met the primary endpoint of overall survival (time from treatment until death of any cause) in patients who took the medication, with an average overall survival spanning more than one year at the time of the data collection.
Balversa was superior to standard chemotherapy, with a 36% decrease in risk of death over chemo, but the study’s safety monitoring committee recommended that the study be stopped, as they believed that patients who were randomized to chemotherapy should be given the opportunity to take Balversa.
Results from the Cohort 1 trial were presented at the 2023 late-breaking session at the American Society of Clinical Oncology Annual Meeting.
“Balversa continues to generate promising clinical findings for patients with FGFR-altered metastatic urothelial cancer, who often face poor disease outcomes. Through the ongoing development of this targeted therapy, we are committed to transforming bladder cancer treatment to positively impact the lives of patients,” explained Dr. Peter Lebowitz, Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC.
In 2018, Balversa received Breakthrough Therapy Designation acceptance from the FDA, and later in 2019 to treat patients with locally advanced or metastatic urothelial carcinoma which obtains FGFR3 or FGFR2 genetic alterations. Alongside this, treatment aided those who progressed during or after one line of chemotherapy, which included the timeline of 12 months of neoadjuvant or adjuvant chemotherapy, according to Janssen.
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