On April 12, the Food and Drug Administration granted accelerated approval to erdafitinib (Balversa, Janssen Pharmaceutical Companies) for patients with locally advanced or metastatic urothelial carcinoma, with susceptible FGFR3 or FGFR2 genetic alterations, that has progressed during or following platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.
The FDA also approved the therascreen FGFR RGQ RT-PCR Kit developed by Qiagen for use as a companion diagnostic for this therapeutic indication.
Read the full FDA press release here.
Posted 4/12/2019
Understanding both the benefits to be had from offering BsAb therapy to its community and the scope of this undertaking, Vanderbilt-Ingram Cancer Center took a novel approach with its APP-led BsAb step-up dosing clinic, which won the program a 2026 ACCC Innovator Award.
