2023-11-21| Trials & Approvals

Astellas and Pfizer’s Drug Receives FDA Approval as Treatment for High-Risk Prostate Cancer Recurrence

by Sinead Huang
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Astellas Pharma Inc. and Pfizer Inc. have achieved a milestone with the U.S. Food and Drug Administration (FDA) granting approval for a supplemental New Drug Application for XTANDI® (enzalutamide). This approval makes Xtandi the first and only androgen receptor signaling inhibitor endorsed by the FDA for the treatment of patients with nonmetastatic castration-sensitive prostate cancer (nmCSPC) exhibiting biochemical recurrence at high risk for metastasis (high-risk BCR).

Related article: Astellas Clears Primary Endpoints In Prostate Cancer And Menopause Trials

Broad Indications and Record-Breaking Sales

Xtandi is a small molecule androgen receptor signaling inhibitor that received its first FDA approval in August 2012, marking its official entry into the market. Since then, it has received multiple FDA approvals for expanded usage, and its current indications cover both castration-sensitive and castration-resistant prostate cancer, making it the only novel hormonal therapy approved for three different types of prostate cancer.

During its 11 years on the market, Xtandi has consistently achieved record-breaking global sales, even ranking among the top 20 best-selling drugs globally at one point. According to Astellas’ financial reports, Xtandi stands out as the company’s highest-performing drug. For the fiscal year 2022 (ending March 31, 2023), its sales reached an impressive 661.1 billion Japanese yen (approximately 4.52 million US dollars), reflecting a significant increase of about 24% compared to the previous year.

Addressing a Critical Gap in Prostate Cancer Care

Prostate cancer survivors, particularly those who have undergone definitive treatments like prostatectomy or radiotherapy, often face the challenge of biochemical recurrence (BCR), affecting 20-40% of them within 10 years. Of those with high-risk BCR, approximately 9 out of 10 will progress to metastatic disease, with 1 in 3 succumbing to metastatic prostate cancer. The approval of Xtandi offers a promising therapeutic option for patients experiencing this distressing recurrence, providing hope to both patients and caregivers.

The FDA’s decision stems from results obtained from the Phase 3 EMBARK trial, evaluating Xtandi in combination with leuprolide, as a single agent, and a placebo plus leuprolide in nmCSPC patients with high-risk BCR. The trial demonstrated a statistically significant reduction in the risk of metastasis or death in patients treated with Xtandi plus leuprolide, marking a crucial advancement in evidenced-based care for patients with high-risk BCR. Medical professionals, such as Dr. Neal Shore, highlight the importance of this FDA approval in expanding treatment options for patients at risk of metastasis.

Future Implications and Global Regulatory Review

As Xtandi’s approval reshapes prostate cancer care in the U.S., the drug is under review by regulatory authorities worldwide, including the European Medicines Agency. The potential expansion of its indication in nonmetastatic hormone-sensitive prostate cancer (nmHSPC) with high-risk BCR awaits regulatory decisions. With over one million patients globally having been treated with Xtandi, the drug’s legacy in prostate cancer care is further solidified, promising hope for more patients worldwide.

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