[{"orgOrder":0,"company":"Basilea Pharmaceutica","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Basilea Announces Data Presentations at ESMO Virtual Congress 2020","therapeuticArea":"Oncology","highestDevelopmentStatus":"Preclinical","country":"SWITZERLAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"July 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Preclinical"},{"orgOrder":0,"company":"Johnson & Johnson Innovative Medicine","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Janssen Presents Results from Phase 1b\/2 NORSE Study in Patients with Metastatic or Locally Advanced Urothelial Carcinoma Treated with BALVERSA\u00ae (erdafitinib) in Combination with Cetrelimab, a PD-1 Inhibitor","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"September 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Johnson & Johnson Innovative Medicine","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Janssen Presents Initial Results from the Phase 2 RAGNAR Study of BALVERSA\u00ae (erdafitinib) in Patients with Advanced Solid Tumors with FGFR Alterations","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Johnson & Johnson Innovative Medicine","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Janssen Submits Supplemental New Drug Application to the U.S. Food and Drug Administration Seeking Full Approval of BALVERSA\u00ae (erdafitinib) for the Treatment of Patients with Locally Advanced or Metastatic Urothelial Carcinoma and Selected Fibroblast Grow","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"August 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Johnson & Johnson Innovative Medicine","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Janssen Submits Marketing Authorisation Application to the European Medicines Agency Seeking Approval of Erdafitinib for the Treatment of Patients with Locally Advanced or Metastatic Urothelial Cancer with Susceptible FGFR Alterations","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"September 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Johnson & Johnson","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"First Results with Erdafitinib-Releasing Intravesical Delivery System (TAR-210) Show Early Evidence of Positive Clinical Activity in Patients with Non-Muscle-Invasive Bladder Cancer with Select Fibroblast Growth Factor Receptor Alterations","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"October 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"Johnson & Johnson","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Results from Phase 2 THOR-2 Study Show Improved Rates of Recurrence-Free Survival in Patients with High-Risk Non-Muscle-Invasive Bladder Cancer with Select Fibroblast Growth Factor","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"October 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"Johnson & Johnson","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"U.S. Food and Drug Administration Grants Full Approval for BALVERSA\u00ae to Treat Locally Advanced or Metastatic Bladder Cancer with Select Genetic Alterations","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"January 2024","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Johnson & Johnson Innovative Medicine","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"TAR-210 Results Show 90 Percent Recurrence-Free Survival and 90 Percent Complete Response in Patients with High-Risk and Intermediate-Risk Non-Muscle-Invasive Bladder Cancer, Respectively","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2024","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"}]
Find Clinical Drug Pipeline Developments & Deals for Erdafitinib
TAR-210 is an intravesical delivery system designed to provide sustained, local release of erdafitinib into the bladder in patients with non-muscle-invasive bladder cancer (NMIBC) with select fibroblast growth factor receptor (FGFR) alterations.
Balversa (erdafitinib) is a once-daily, oral FGFR kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible fibroblast growth factor receptor 3 (FGFR3) genetic alterations.
TAR-210 is an intravesical delivery system designed to provide sustained, local release of erdafitinib into the bladder in patients with non-muscle-invasive bladder cancer (NMIBC) with select fibroblast growth factor receptor (FGFR) alterations.
Balversa (erdafitinib) is a once-daily, oral FGFR kinase inhibitor. It is being evaluated for the treatment of non-muscle-invasive bladder cancer with select fibroblast growth factor.
BALVERSA (erdafitinib) is a once-daily, oral FGFR kinase inhibitor that is approved by the U.S. FDA and EMA for the treatment of adults with locally advanced or mUC that have susceptible FGFR3 or FGFR2 genetic alterations.
BALVERSA® (erdafitinib) is a once-daily, oral FGFR kinase inhibitor that is approved by the U.S. FDA for the treatment of adults with locally advanced or mUC that have susceptible FGFR3 or FGFR2 genetic alterations.
The safety profile of BALVERSA (Erdafitinib) observed in RAGNAR was consistent with the known safety profile of erdafitinib in metastatic urothelial carcinoma (mUC). Across tumor types, 44.9 percent of patients experienced adverse events of grade three or above.
The safety profile of BALVERSA® in combination with cetrelimab was generally similar to that of BALVERSA® monotherapy used in bladder cancer. With this combination of erdafitinib and cetrelimab change tumor microenvironment to make it more receptive to PD-1 intervention.
The preclinical derazantinib data may provide an explanation for differences in reported adverse event profiles between various FGFR kinase inhibitors. Furthermore, derazantinib shows promising efficacy in patient-derived tumor models with gene aberrations in FGFR1-3.
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