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November 17, 2023 : Pfizer and Astellas Pharma Inc. have announced the U.S. Food and Drug Administration (FDA) approval of XTANDI® (enzalutamide) for the treatment of patients with nonmetastatic castration-sensitive prostate cancer (nmCSPC) with a high risk of metastasis. This expanded indication represents a significant breakthrough in prostate cancer treatment, offering a new option for patients with earlier stages of the disease.
XTANDI, a hormonal therapy that blocks the production of testosterone, was previously approved for use in patients with metastatic prostate cancer. The FDA’s recent decision extends XTANDI’s reach to patients with nmCSPC, a stage of prostate cancer where the cancer has not yet spread to other parts of the body but is at high risk of doing so.
The approval is based on data from the Phase 3 ARCHES trial, which demonstrated that XTANDI significantly improved metastasis-free survival (MFS) in patients with nmCSPC and high-risk disease compared to placebo. The trial also showed that XTANDI had a favorable safety profile.
“The FDA approval of XTANDI for nmCSPC with a high risk of metastasis is a major step forward in the treatment of prostate cancer,” said Chris Boshoff, M.D., Ph.D., Chief Oncology Research and Development Officer and Executive Vice President at Pfizer. “XTANDI has already proven its efficacy and safety in patients with metastatic prostate cancer, and this new indication has the potential to help even more patients live longer healthier lives.”
The FDA approval of XTANDI for nmCSPC is a significant development in the fight against prostate cancer. The drug’s ability to delay metastasis and prolong survival in patients with early-stage disease offers new hope for a population previously treated with observation or watchful waiting.
The approval is also a testament to the growing role of targeted therapies in cancer treatment. XTANDI’s mechanism of action specifically targets the androgen receptor signaling pathway involved in prostate cancer growth, demonstrating the potential of precision medicine to improve patient outcomes.
The expanded indication for XTANDI is expected to have a substantial impact on the prostate cancer treatment landscape. The drug’s efficacy and favorable safety profile make it a promising option for patients with nmCSPC and high-risk disease.
The FDA approval of XTANDI for nmCSPC marks a significant advance in prostate cancer treatment. The drug’s ability to delay metastasis and extend survival in early-stage disease offers new hope for patients and demonstrates the potential of targeted therapies to improve patient outcomes.
