The FDA Approves Expanded Applications for Astellas and Pfizer's XTANDI®

Published: November 2023


On 17 November 2023, Pfizer and Astellas Pharma announced the approval of supplemental New Drug Application (sNDA) for XTANDI® (enzalutamide) by the Food and Drug Administration (FDA). The FDA has granted expanded indications for two prominent cancer treatments—Merck’s Keytruda and Pfizer and Astellas’ Xtandi. XTANDI® becomes the first and only androgen receptor signaling inhibitor approved by the FDA for the treatment of patients with nonmetastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR). This approval was supported by the phase III EMBARK trial, demonstrating that XTANDI® in combination with the hormone reducer leuprolide significantly reduced the risk of metastasis or death compared to placebo and leuprolide. Additionally, XTANDI® as a monotherapy achieved a statistically significant reduction in the risk of metastasis or death compared to the same placebo and leuprolide combination as a secondary measure.

This approval signifies a significant advancement, potentially establishing Xtandi as a new standard-of-care option, as highlighted by Shore in a released statement. The FDA expedited Pfizer and Astellas’ application with priority review, fast-track, and real-time oncology designations. Xtandi stands as the sole novel hormone therapy approved for three types of prostate cancer. Sales of Xtandi soared to $5.9 billion in 2022, marking a 27% increase from the previous year.
According to Roots Analysis, the Cancer Therapeutics Market is anticipated to grow at a CAGR of 84% during the forecasted period.

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