Pending approval, erdafitinib would become the first therapy targeting FGFR3 alterations in patients with metastatic urothelial carcinoma, one of Europe’s most common cancers1 The...
When the FDA converts an accelerated approval into a full nod, it’s typically associated with a wider label for the drug at hand.
FDA approves erdafitinib for locally advanced or metastatic urothelial carcinoma
Investigational TAR-210 first-in-human results highlight the potential for local sustained release of erdafitinib with a novel intravesical delivery system.1 Phase 1 results show a manageable safety...
Data from Cohort 1 of the Phase 2 THOR-2 study showed oral erdafitinib reduced the risk of disease recurrence or death compared with intravesical standard-of-care chemotherapy1 ...
Pending approval, erdafitinib, an investigational, once-daily oral pan-fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor,1 will become the first therapy targeting FGFR alterations in...
RARITAN, N.J., Aug. 28, 2023 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking full approval of BALVERSA® (erdafitinib), a kinase inhibitor, for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) that has susceptible fibroblast growth factor receptor (FGFR)3 genetic alterations, and progressed during or following at least one line of a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor in the locally advanced or metastatic setting or within 12 months of neoadjuvant or adjuvant therapy.1
Treatment with erdafitinib (Balversa) resulted in clinical benefit for patients with advanced solid tumors harboring susceptible FGFR alterations who had exhausted all other treatment options, meeting the primary end point of overall response rate (ORR) of the phase 2 RAGNAR trial (NCT04083976), according to findings published in the Lancet Oncology.1
FDA Confirms Paragraph IV Patent Litigation for Erdafitinib Tablets
Johnson & Johnson’s Balversa can keep some metastatic bladder cancer patients alive longer than chemotherapy, according to a study of 266 who have fibroblast growth factor receptor (FGFR) gene mutations and had already received checkpoint inhibitors.