Pfizer and Astellas XTANDI Approved by US FDA in Earlier Prostate Cancer Treatment Setting
Enzalutamide Receives Expanded Approval for High-Risk Biochemical Recurrence
Pfizer and Astellas Pharma US, Inc. today announced that the US Food and Drug Administration (FDA) has approved XTANDI® (enzalutamide) in combination with androgen deprivation therapy (ADT) for the treatment of patients with prostate cancer who have high-risk biochemical recurrence (HRbCR) following definitive local therapy.
XTANDI is now the only oral therapy approved by the FDA for this earlier stage of prostate cancer, providing patients with a new treatment option to help prevent the spread of their disease.
"The FDA's approval of XTANDI for HRbCR is a significant milestone in the treatment of prostate cancer," said Chris Boshoff, Chief Development Officer, Oncology, Pfizer Global Product Development. "We are committed to providing patients with the best possible care, and this approval gives them a new option to help them live longer, healthier lives."
HRbCR is a condition in which prostate cancer recurs after definitive local therapy, such as surgery or radiation therapy. The cancer cells may still be present in the body, but they are not yet detectable by standard imaging tests. HRbCR is associated with a high risk of developing metastatic prostate cancer, which is more difficult to treat.
XTANDI is an androgen receptor inhibitor that blocks the action of androgens, hormones that can fuel the growth of prostate cancer. In the Phase 3 ARCHES trial, XTANDI plus ADT significantly improved metastasis-free survival (MFS) compared to ADT alone in patients with HRbCR. The median MFS was 40.6 months for patients receiving XTANDI plus ADT compared to 28.6 months for patients receiving ADT alone (HR=0.69; 95% CI: 0.58-0.83; p
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