Astellas Pharma Inc. and Medivation, Inc. have announced that the U.S. Food and Drug Administration (FDA) approved a new indication for the use of XTANDI® (enzalutamide) capsules to treat patients with metastatic castration-resistant prostate cancer (mCRPC). This new approval is based on a priority review of the supplemental New Drug Application (sNDA) that was based on results from the Phase 3 PREVAIL trial.
Enzalutamide, or XTANDI, is an oral, once-daily androgen receptor inhibitor that acts on three different steps in the androgen receptor signaling pathway and it was first approved by the FDA in August 2012 for use in patients with mCRPC who previously received docetaxel, a drug used in chemotherapy.
With this new approval, XTANDI can also be used in men suffering from mCRPC who have not received chemotherapy.
“The FDA’s priority review and approval of this new indication for XTANDI now enables the use of an important therapy by patients with metastatic castration-resistant prostate cancer at all stages of their disease. We are pleased that these patients now have XTANDI available as a treatment option,” Sef Kurstjens, M.D., Ph.D., chief medical officer of Astellas Pharma Inc. and president of Astellas Pharma Global Development, Inc. said in a PR Newswire press release.
“All of us at Medivation extend our thanks to the clinicians and patients who participated in the PREVAIL clinical trial culminating in today’s approval. As a company dedicated to the rapid development of novel therapies to treat serious diseases, we are pleased to see XTANDI approved in this important patient population,” David Hung, M.D., founder, president and chief executive officer, Medivation, Inc. added in the press release.
Results obtained in the Phase 3 PREVAIL trial showed that men receiving XTANDI and Gonadotropin-Releasing Hormone Agonist (GnRH) therapy had a statistically significant improvement in both overall survival and delayed time to radiographic progression or death as compared to those on placebo and GnRH therapy alone. Furthermore, XTANDI significantly reduced the risk of radiographic progression or death by 83% compared with placebo along with reduced risk of death by 29% and delayed time to initiation of chemotherapy and time to a skeletal related event.
“Enzalutamide has been studied and is approved for patients with metastatic prostate cancer that is resistant to primary hormonal therapy, a disease state we call castration-resistant prostate cancer. In this setting, enzalutamide has been shown to extend overall survival and significantly delay the progression of prostate cancer. Furthermore, in the PREVAIL trial, the median time to initiating chemotherapy was delayed by 17 months with enzalutamide treatment as compared to placebo, so the result is a meaningful period of time during which men have their disease controlled without the need for chemotherapy,” Tomasz M. Beer, M.D., F.A.C.P., co-principal investigator of the PREVAIL study, deputy director of the Knight Cancer Institute and professor of medicine at Oregon Health & Science University concluded in the press release.
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