Pfizer, Astellas secure expanded FDA approval for XTANDI

Pfizer and Astellas Pharma have secured approval for a new indication for XTANDI (enzalutamide) from the US Food and Drug Administration (FDA) to include its use in metastatic castration-sensitive prostate cancer (mCSPC).

The latest approval means that XTANDI is indicated for the treatment of three distinct forms of advanced prostate cancer that include non-metastatic and metastatic castration-resistant prostate cancer (CRPC), and mCSPC.

XTANDI is an androgen receptor inhibitor, which helps to reduce the frequency of androgens connecting with an androgen receptor. Through this mechanism, the hormone therapy can restrict tumours from growing, thereby leading to the possible death of cancer cells.

Pfizer oncology global president Andy Schmeltz said: "Today’s approval adds to over a decade of global clinical research aimed at better understanding the potential benefit of XTANDI for men with advanced prostate cancer.

"The FDA approval marks continued progress to help meet the needs of patients, including men living with metastatic castration-sensitive prostate cancer."

The approval of XTANDI’s supplemental new drug application (sNDA) for the treatment of mCSPC has been given based on results from the phase 3 ARCHES trial, which featured 1,150 men with mCSPC. The late-stage trial met its primary endpoint of radiographic progression-free survival (rPFS).

Data from the ARCHES study showed that the use of XTANDI plus androgen deprivation therapy (ADT) lowered the risk of radiographic progression or death significantly by 61% compared to placebo plus ADT.

The safety analysis of the ARCHES study is generally in line with the safety profile of the androgen receptor inhibitor as seen in previous clinical trials in CRPC, said Pfizer.

The approval for the drug for mCSPC follows the priority review designation granted by the FDA based on the findings of the ARCHES trial. mCSPC is also known as metastatic hormone-sensitive prostate cancer (mHSPC).

Astellas Pharma senior vice president and oncology therapeutic area head Andrew Krivoshik said: "XTANDI has been established as a standard of care for men with castration-resistant prostate cancer and has been prescribed to more than 420,000 patients worldwide since it was first approved in 2012.

"This approval in metastatic castration-sensitive prostate cancer means physicians can now offer XTANDI to men earlier in their advanced prostate cancer treatment journey."

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