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FDA Grants Accelerated Approval to Astellas’ and Seattle Genetics’ PADCEV

Yesterday, the U.S. Food and Drug Administration announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval to PADCEV™ for the treatment of adult patients 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.

PADCEV is approved under the FDA’s Accelerated Approval Program based on tumor response rate. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.

Read Seattle Genetics’ and Astellas’s press release here.

Walk with BCAN, Talk with BCAN

Please join us for two exciting virtual events
in October 2020

Fall Virtual Walk to End Bladder Cancer
October 3, 2020 at 11:00 am ET

Virtual Summit for Patients and Families
October 10, 2020 at 1:00 pm ET