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The FDA has granted a priority review to a Biologics License Application for enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced, or metastatic setting and a PD-1/PD-L1 checkpoint inhibitor.

The initial pilot study of CTL019 in heavily pretreated CD19-positive hematologic malignancies demonstrated the feasibility of CAR T-cell therapy in patients with CLL. A presentation at the 2019 American Society of Gene & Cell Therapy Annual Meeting reported 2 cases of chemotherapy-resistant CLL, with ongoing follow- up at 8 years showing persistence of CAR-engineered T cells and sustained remission, as determined by flow cytometry and deep sequencing of immunoglobulin H rearrangements. 

In an interview with Targeted Oncology, Arlene Siefker-Radtke, MD, discussed the results from this trial that led to the approval of erdafitinib in patients with locally advanced or metastatic bladder cancer who have progressed on platinum-based chemotherapy. She also explained the impact of this approval in this patient population and next steps planned for this agent.