Pfizer and Astellas’ Xtandi approved by FDA for earlier prostate cancer indication

20 Nov 2023
www.pmlive.com
Clinical ResultPhase 3Drug Approval
Pfizer and Astellas’ Xtandi approved by FDA for earlier prostate cancer indication
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Source: PMLiVE
Pfizer and Astellas’ Xtandi (enzalutamide) has been approved by the US Food and Drug Administration (FDA) to treat non-metastatic castration-sensitive prostate cancer (nmCSPC) patients with biochemical recurrence (BCR) and a high risk of metastasis.
The regulator’s decision makes Xtandi, which has been authorised for use with or without a gonadotropin-releasing hormone (GnRH) analog therapy, the first androgen receptor signalling inhibitorandrogen receptor signalling inhibitor approved for use in this subset of patients.
The treatment is already approved in the US for castration-resistant prostate cancer and metastatic castration-sensitive prostate cancer.
Compared with those indications, nmCSPC represents an earlier stage of disease, in which there is no detectable evidence of the cancer spreading to distant parts of the body (metastases) and it still responds to testosterone-lowering treatments.
However, between 20% and 40% of patients who have undergone prostate cancer treatment will experience BCR within ten years, and about nine out of ten of those with high-risk BCR will develop metastatic disease.
The companies’ supplemental new drug application was supported by positive results from the phase 3 EMBARK trial, which demonstrated a statistically significant and clinically meaningful improvement in metastasis-free survival for high BCR-risk nmCSPC patients treated daily with Xtandi plus the GnRH agonist leuprolide versus placebo plus leuprolide.
The study also met a key secondary endpoint, demonstrating that patients treated with Xtandi as a single agent had a statistically significant reduction in the risk of metastasis or death versus placebo plus leuprolide.
“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,” said Chris Boshoff, chief oncology research and development officer and executive vice president at Pfizer.
Ahsan Arozullah, senior vice president and head of oncology development at Astellas, said: “[The] 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.”
The companies outlined that Xtandi is currently under review with other regulatory authorities, including the European Medicines Agency, to support an expanded indication based on the results of EMBARK.
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