Pfizer, Astellas obtain FDA OK for Xtandi

Astellas Pharma and Pfizer have received the Food and Drug Administration’s permission for Xtandi (enzalutamide).

Xtandi is the first and only androgen receptor signaling inhibitor approved by the FDA for the treatment of patients with nonmetastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis (high-risk BCR). Patients with nmCSPC with high-risk BCR may be treated with XTANDI with or without a gonadotropin-releasing hormone analog therapy.

“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,” said Courtney Bugler, president and CEO of ZERO Prostate Cancer. “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.” 

“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 biochemical recurrence, also known as nmCSPC, until the completion of the EMBARK trial,” said Neal Shore, chief medical officer of Strategic Innovation and Pharmacy, GenesisCare USA, director, CPI, Carolina Urologic Research Center, and primary investigator for the EMBARK trial. 

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Shore continued, “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.”   

“Today’s FDA approval is the culmination of over a decade of research and development as we’ve worked to bring Xtandi forward for as many patients with prostate cancer as possible who may benefit,” said Ahsan Arozullah, senior vice president and head of oncology development  at Astellas. “With every milestone, our clinical development program has played an instrumental role in changing the course of patients’ lives. We are proud that XTANDI can now be offered to a subset of men with nonmetastatic castration-sensitive prostate cancer with biochemical recurrence and at high risk for metastases.”

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“More than 300,000 men in the U.S. 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,” said Chris Boshoff, chief oncology research and development officer and executive vice president at Pfizer. “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.”