Item 8.01 Other Events

On July 9th, 2021, Seagen Inc. (the "Company") and Astellas Pharma Inc. ("Astellas") issued a press release announcing that the U.S. Food and Drug Administration had: 1) converted the accelerated approval of PADCEV® (enfortumab vedotin-ejfv) to regular approval 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 urothelial cancer setting; and 2) granted regular approval for a new PADCEV indication for adult patients with locally advanced or metastatic urothelial cancer who are ineligible for cisplatin containing chemotherapy and have previously received one or more prior lines of therapy. The press release issued by the Company and Astellas is attached as Exhibit 99.1 to this current report and is incorporated by reference herein.

Item 9.01 Financial Statements and Exhibits




(d) Exhibits



99.1      Press Release of Seagen Inc. and Astellas Pharma Inc. dated July 9, 2021

104     Cover Page Interactive Data File (formatted as Inline XBRL)

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