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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