A mere 26 months after the first patient was enrolled in its pivotal phase II study and about three months ahead of its PDUFA date, the FDA granted accelerated approval for Padcev (enfortumab vedotin-ejfv) to treat adults with locally advanced or metastatic urothelial cancer who have previously received a PD-1/L1 inhibitor and a platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery or in a locally advanced or metastatic setting.
The Guardant360 assay accurately detected genomic alterations that permit patient matching to targeted therapies, according to a presentation of the plasmaMATCH study at the 2019 San Antonio Breast Cancer Symposium. The study is the largest ever performed for a liquid biopsy.