FDA approved Balversa (erdafitinib) for adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations, as determined by an FDA-approved companion diagnostic test, whose disease has progressed on or after at least one line of prior systemic therapy.
AstraZeneca’s application for camizestrant, a next-generation oral selective estrogen receptor degrader, or SERD, in metastatic breast cancer might have seemed set to sail smoothly through the FDA approval process.
