China National Medical Products Administration approves tislelizumab to treat metastatic urothelial carcinoma with PD-L1 high expression .- BeiGene Ltd
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Genentech/Roche announced the FDA Oncologic Drugs Advisory Committee voted 10 to 1 in favor of maintaining accelerated approval of Tecentriq (atezolizumab) for the treatment of adults with locally advanced or metastatic urothelial carcinoma (mUC, bladder cancer) who are not eligible for cisplatin-containing chemotherapy and whose tumors express high levels of PD-L1 (PD-L1–stained tumor-infiltrating immune cells covering at least 5 percent of the tumor area) as determined by an FDA-approved test or are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status.
Astellas Pharma and Seagen have filed two supplemental Biologics License Application (sBLA) submissions with the FDA for Padcev (enfortumab vedotin-ejfv) for review as part of the Real-Time Oncology Review (RTOR) pilot program.
Gilead Sciences, Inc. announced that the FDA has granted accelerated approval of Trodelvy (sacituzumab govitecan-hziy) for use in adult patients with locally advanced or metastatic urothelial cancer (UC) who have previously received a platinum-containing chemotherapy and either a programmed death receptor-1 (PD-1) or a programmed death-ligand 1 (PD-L1) inhibitor.