Tag: Astellas Pharma

April 13, 2022 Off

EC Approves Astellas-Seagen’s Locally Advanced or Metastatic Urothelial Cancer Drug

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Astellas Pharma Inc. and Seagen Inc. (Nasdaq:SGEN) have announced that the European Commission (EC) has approved PADCEV (enfortumab vedotin) as monotherapy for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a PD-1/L1 inhibitor. The EC approval is supported by data from the global phase 3 EV-301 trial that demonstrated an overall survival (OS) benefit compared with chemotherapy.

March 29, 2021 Off

FDA approves new indication for Astellas Pharma’s bladder dysfunction drug

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The U.S. Food and Drug Administration approved a new indication for  Astellas Pharma’s  Myrbetriq (mirabegron extended-release tablets) and Myrbetriq Granules (mirabegron for extended-release oral suspension) to treat neurogenic detrusor overactivity (NDO), a bladder dysfunction related to neurological impairment, in children ages three years and older.