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Pfizer and Astellas XTANDI® Approved by U S FDA in Earlier Prostate Cancer Treatment Setting

/PRNewswire/ Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and Pfizer Inc. (NYSE: PFE) today announced that the companies.

United statesChris boshoffNaoki okamuraAhsan arozullahCourtney buglerHead of oncology developmentAmerican urological association annual meetingAstellas pharma incDrug administrationOncology researchAmerican society of clinical oncologyCarolina urologic research centerPfizer incExchange commissionEuropean unionPrnewswire astellas pharma inc

Pfizer (PFE) and Astellas XTANDI Approved by FDA in Earlier Prostate Cancer Treatment Setting

Pfizer (PFE) and Astellas XTANDI Approved by FDA in Earlier Prostate Cancer Treatment Setting
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United statesAhsan arozullahChris boshoffCourtney buglerHead of oncology developmentOncology researchAmerican urological association annual meetingDrug administrationAstellas pharma incPfizer incEuropean medicines agencyCarolina urologic research centerAstellas pharmaNew drug applicationPriority reviewFast track

FDA Expands Enzalutamide Approval to Earlier Prostate Cancer

The expanded approval makes enzalutamide the first and only approved androgen receptor signaling inhibitor in the nonmetastatic castration-sensitive prostate cancer setting.

United statesEuropean society of medical oncologyAmerican urological association annual meetingDrug administrationUrological association annual meetingMedical oncologyMedscape medicalNew england journalProstate carcinomaAlignant prostate neoplasmProstate cancerAncer prostateAlignant neoplasiaUs food and drug administrationNited states food and drug administrationGnrh agonists

European Medicines Agency Validates Type II Variation for Astellas XTANDI® (enzalutamide) for Treatment of Non-Metastatic Hormone-Sensitive Prostate Cancer with High-Risk Biochemical Recurrence

European Medicines Agency Validates Type II Variation for Astellas XTANDI® (enzalutamide) for Treatment of Non-Metastatic Hormone-Sensitive Prostate Cancer with High-Risk Biochemical Recurrence
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United statesNaoki okamuraAhsan arozullahDrug administrationMedivation incAmerican society of clinical oncologyEuropean unionAmerican urological association annual meeting onAstellas incHead of oncology developmentEuropean medicines agencyAstellas pharma incPrnewswire astellas pharma incSenior vice presidentOncology developmentUrological association annual meeting

European Medicines Agency Validates Type II Variation for Astellas XTANDI® (enzalutamide) for Treatment of Non-Metastatic Hormone-Sensitive Prostate Cancer with High-Risk Biochemical Recurrence

European Medicines Agency Validates Type II Variation for Astellas XTANDI® (enzalutamide) for Treatment of Non-Metastatic Hormone-Sensitive Prostate Cancer with High-Risk Biochemical Recurrence
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United statesAhsan arozullahNaoki okamuraDrug administrationMedivation incAstellas pharma incEuropean unionAmerican society of clinical oncologyHead of oncology developmentAstellas incAmerican urological association annual meeting onEuropean medicines agencyEuropean medicines agency validates typeNon metastatic hormone sensitive prostate cancerHigh risk biochemicalSenior vice president