Astellas Pharma, Inc. is a global pharmaceutical company developing therapies for the treatment of various diseases. Japanese Pharma major came into existence, as a result of merger of Fujisawa Pharmaceutical Co. and Yamanouchi Pharmaceutical Co. in Apr 2005.
- In Dec 2019, the US FDA granted accelerated approval to enfortumab vedotin-ejfv (PADCEV) for adult patients with locally advanced or metastatic urothelial cancer who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting. PADCEV is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells. Astellas and Seattle Genetics are advancing the development of PADCEV worldwide, and under the collaboration, shares the costs and profits on a 50:50 basis worldwide.
- Astellas’ XOSPATA is a FLT3 inhibitor for adult patients with relapsed or refractory Acute Myeloid Leukemia (AML) with a FLT3 mutation-positive. It was launched in Japan and the United States in Dec 2018 and in Europe in Nov 2019.
- On May 2013, FDA approved Erlotinib/Tarceva®, for the first-line treatment of patients with metastatic non-small cell lung cancer whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations.
- In 2012, Enzalutamide (Xtandi; Astellas, Pfizer), an androgen receptor inhibitor, received US FDA approval for the treatment of men with metastatic castration-resistant prostate cancer who previously received docetaxel. Astellas and Pfizer jointly commercialize XTANDI in the United States and Astellas has responsibility for manufacturing and all additional regulatory filings globally, as well as commercializing XTANDI outside the United States.
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