#ASCO21: Ahead of August PDUFA date, Astellas and Seagen sweeten Padcev pitch with new data
Astellas and Seagen made waves back in 2019 when they nabbed conditional approval for their Nectin-4 targeting therapy Padcev in urothelial cancer. Now, as the FDA considers a full approval and label expansion, the companies have some new data to share ahead of their August PDUFA date.
Padcev was initially OK’d in the locally advanced or metastatic setting for patients who already received a PD-1 or PD-L1 inhibitor and platinum chemotherapy. The new analysis, however, comes from a second cohort of Phase II patients who couldn’t take cisplatin chemo for medical reasons.
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