Balversa in other cancers – pro
The U.S. Food and Drug Administration granted accelerated approval to Balversa (erdafitinib), a treatment for adult patients with locally advanced or metastatic bladder cancer that has a type of susceptible genetic alteration known as FGFR3 or FGFR2, and that has progressed during or following prior platinum-containing chemotherapy. Patients should be selected for therapy with Balversa using an FDA-approved companion diagnostic device. Neither the use for this diagnosis nor the targeting of a mutation based on the presence of that mutation alone is medically necessary
Siefker-Radtke A, et al. First results from the primary analysis population of the phase 2 study of erdafitinib (ERDA; JNJ-42756493) in patients (pts) with metastatic or unresectable urothelial carcinoma (mUC) and FGFR alterations (FGFRalt). J Clin Oncol. 2918;36(suppl; abstr 4503).
Rastilav Bahleda, Antoine Italiano, Cinta Hierro, Alain C. Mita, Andres Cervantes, Nancy Chan, Mark M. Awad, Emiliano Calvo, Victor Moreno, Ramaswamy Govindan, Alexander I Spira, Martha D Gonzalez, Bob Zhong, Ademi E. Santiago-Walker, Italo Poggesi, Trilok Parekh, Hong Xie, Jeffrey R. Infante and Josep Tabernero, Multicenter Phase I Study of Erdafitinib (JNJ-42756493), Oral Pan-Fibroblast Growth Factor Receptor Inhibitor, in Patients with Advanced or Refractory Solid TumorsPublished OnlineFirst May 14, 2019 doi: 10.1158/1078-0432.CCR-18-3334