Xtandi Approved for High-Risk Prostate Cancer - NCI
WEBJan 5, 2024 — Enzalutamide (Xtandi) can now be used alone or combined with leuprolide to treat some people with prostate cancer who have had a biochemical recurrence.
Johnson & Johnson's Erleada Shows Improved Overall Survival In …
WEB1 day ago — Wednesday, Johnson & Johnson (NYSE:JNJ) revealed results from a head-to-head study of Erleada (apalutamide) compared to Pfizer Inc’s (NYSE:PFE) Xtandi (enzalutamide). The data showed that ...
Improved Outcomes with Enzalutamide in Biochemically …
WEBOct 18, 2023 — In patients with prostate cancer with high-risk biochemical recurrence, enzalutamide plus leuprolide was superior to leuprolide alone with respect to metastasis-free survival; enzalutamide...
FDA approves enzalutamide for prostate cancer
WEBOn November 16, 2023, the Food and Drug Administration approved enzalutamide (Xtandi, Astellas Pharma US, Inc.) for non-metastatic castration-sensitive prostate cancer …
Breaking News: FDA Approves Enzalutamide as a Treatment …
WEBNov 17, 2023 — Now, patients and their doctors have a new treatment option that decreases these risks. The FDA has approved enzalutamide alone OR in combination with hormone therapy (such as leuprolide) for patients with high-risk biochemical recurrence.
Pfizer and Astellas' XTANDI® Approved by U.S. FDA in Earlier …
WEBNov 16, 2023 — XTANDI (enzalutamide) is indicated in the U.S. for the treatment of patients with castration-resistant prostate cancer (CRPC), metastatic castration-sensitive prostate cancer (mCSPC) and nonmetastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR).
Phase 3 Study Shows XTANDI® (enzalutamide) plus Leuprolide ... - Pfizer
WEBMar 16, 2023 — XTANDI (enzalutamide) is indicated in the U.S. for the treatment of patients with castration-resistant prostate cancer (CRPC) and metastatic castration-sensitive prostate cancer (mCSPC). Warnings and Precautions Seizure occurred in 0.5% of patients receiving XTANDI in seven randomized clinical trials. In a …
Talazoparib Combo Approved for Metastatic Prostate Cancer
WEBAug 4, 2023 — FDA based the approval of enzalutamide (Xtandi) plus talazoparib (Talzenna) on a large clinical trial that showed the combination was more effective than enzalutamide alone in treating men with metastatic castration-resistant prostate cancer.
FDA Approves Enzalutamide for Nonmetastatic Castration
WEBNov 20, 2023 — On November 16, the U.S. Food and Drug Administration (FDA) approved the androgen receptor inhibitor enzalutamide (Xtandi) for patients with nonmetastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis.
ENZAMET Update Confirms OS Benefit With Enzalutamide ... - ASCO Daily News
WEBJun 5, 2022 — Key Points: A follow-up of the phase 3 ENZAMET trial confirms the survival benefit with enzalutamide in metastatic hormone-sensitive prostate cancer (mHSPC). Exploratory analyses showed that enzalutamide is active in all prognostic subgroups.