Janssen Submits Marketing Authorization Application to EMA For Approval of Erdafitinib

On Sept. 8, 2023, Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) to seek the approval of erdafitinib for the treatment of adult patients with locally advanced unresectable or metastatic urothelial carcinoma (UC), harboring susceptible fibroblast growth factor receptor 3 (FGFR3) genetic alterations, with disease progression during or following at least one line of therapy containing a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-[L]1) inhibitor, according to the press release.

“For patients with advanced UC, including FGFR-driven tumors, outcomes remain poor and treatment options are limited; therefore, there is a need for novel, targeted therapies,” said Martin Vogel, EMEA Therapeutic Area Lead Oncology, Janssen-Cilag GmbH, in a press release. “We are excited by the prospect of bringing innovative, personalized approaches to market for patients as we work towards our wider goal of making this complex disease a more manageable and ultimately curable condition.”

The MAA is based on data from Cohort 1 of the randomized, controlled, phase III THOR study, evaluating the efficacy and safety of erdafitinib versus chemotherapy. The study met its primary endpoint of overall survival (OS) with patients who received erdafitinib achieving a median OS of over one year at the prespecified interim analysis data cutoff, according to the press release. Further, the independent data safety monitoring committee recommended that the study to be stopped and patients randomized to chemotherapy to be offered the opportunity to cross-over to erdafitinib.

The safety profile of erdafitinib observed in THOR was consistent with the previously reported safety profile of erdafitinib in metastatic urothelial carcinoma (mUC).

“This submission, and Janssen’s ongoing study of erdafitinib, reinforces our commitment to deliver much-needed targeted therapies in the areas of high unmet need, including for devastating diseases like metastatic UC,” said Kiran Patel, MD, vice president, clinical development, Solid Tumors, Janssen Research & Development, LLC, in a press release. “Erdafitinib has demonstrated promising results in advanced, FGFR-altered UC, making this submission a vital step towards improving outcomes for patients in the future. The OS benefit we’ve seen with erdafitinib also supports the need for biomarker testing for FGFR alterations in all patients with metastatic UC.”

Source: Janssen