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Xtandi Approved by FDA for Nonmetastatic Castration-Sensitive Prostate Cancer


Enzalutamide (Xtandi) from Astellas Pharma Inc. and Pfizer Inc. gets FDA approval to treat nonmetastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis.

The FDA has approved a supplemental New Drug Application from Astellas Pharma Inc. and Pfizer Inc. for enzalutamide (Xtandi) to treat nonmetastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence (BCR) at high risk for metastasis.1

Image credit: Dr_Microbe | stock.adobe.com

Image credit: Dr_Microbe | stock.adobe.com

The approval of the application, which was granted FDA Priority Review designation, Fast Track designation, and Real-time Oncology Review, makes Xtandi the first and only androgen receptor signaling inhibitor approved by the FDA for this indication.1

“For patients who were previously treated for prostate cancer and had achieved remission, only to later receive the distressing news of disease recurrence with a risk of metastasis, the emotional toll can be profound,” Courtney Bugler, president and CEO of ZERO Prostate Cancer, said in a press release.1 “This approval of Xtandi is a promising treatment option for the community, offering a ray of hope to patients and their caregivers during these challenging times.”

Patients with nmCSPC with high-risk BCR can be administered Xtandi with or without a gonadotropin-releasing hormone (GnRH) analog therapy. Among patients who have received definitive prostate cancer treatment that includes radical prostatectomy, radiotherapy, or both, between 20% and 40% are projected to experience BCR within 10 years.1 Further, approximately nine of ten patients with high-risk BCR will develop metastatic disease, with one in three deaths resulting from metastatic prostate cancer.

The approval of Xtandi was based on findings from the Phase 3 EMBARK trial (NCT02319837). The trial found that adding Xtandi to leuprolide lowered the risk of metastasis or death by 58% compared to leuprolide monotherapy.2

In the trial, median metastasis-free survival (MFS) had not yet been reached at a median follow-up of 60.7 months in those administered Xtandi and 60.6 months in the placebo cohort. Three-year MFS rates were 92.9% for patients administered Xtandi and 83.5% in the placebo cohort, with 5-year rates of 87.3% and 71.4%, respectively.

“Having had the privilege of taking care of patients with prostate cancer for nearly 40 years, I have been fortunate to have participated in many of the prostate cancer landscape changing trials; notably, we have not progressed our evidenced-based care for patients with BCR, also known as nmCSPC, until the completion of the EMBARK trial,” EMBARK trial primary investigator Neal Shore, MD, FACS, chief medical officer of Strategic Innovation and Pharmacy, GenesisCare USA, director, CPI, Carolina Urologic Research Center, said in a press release. “Previously, treatment options for these BCR patients, especially those who have a high likelihood of developing metastases were limited. The FDA approval of Xtandi for patients with nmCSPC with BCR at high risk of metastasis represents an important advancement whereby an androgen deprivation signaling inhibitor, enzalutamide, has achieved standard of care discussion for patient-physician decision-making.”

Xtandi is also currently under review with the European Medicines Agency for an expanded indication in nmHSPC or nmCSPC with high-risk BCR based on the findings from the EMBARK trial.

“More than 300,000 men in the US have been prescribed Xtandi, and we are excited to have this approval expand the indication for the first time into an earlier setting of the disease,” Chief Oncology Research and Development Officer Chris Boshoff, MD, PhD, executive vice president at Pfizer, said in a press release.1 “This milestone is a testament to Xtandi’s legacy and robust clinical profile, with overall survival demonstrated for patients with metastatic castration-resistant prostate cancer, nonmetastatic castration-resistant prostate cancer, and metastatic castration-sensitive prostate cancer. With today’s approval, we look forward to bringing this therapy to even more patients who have nonmetastatic castration-sensitive prostate cancer at high risk for their cancer metastasizing.”


1. Pfizer and Astellas' XTANDI® Approved by U.S. FDA in Earlier Prostate Cancer Treatment Setting. Astellas Pharma Inc. News release. November 17, 2023. https://www.astellas.com/en/news/28626

2. Freedland SJ, de Almeida Luz M, De Giorgi U, et al. Improved outcomes with enzalutamide in biochemically recurrent prostate cancer. N Engl J Med. 2023;389(16):1453-1465. doi:10.1056/NEJMoa2303974. Accessed November 17, 2023.

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