FDA Grants Xtandi Application Priority Review for Additional Indication in Prostate Cancer

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The supplemental new drug application seeks to add an indication for men with prostate cancer that has spread but is sensitive to hormone therapy.

Pfizer and Astellas Pharma has been granted priority review by FDA for a supplemental new drug application (sNDA) for Xtandi (enzalutamide), an anti-cancer drug, to add an indication for treating men with metastatic hormone-sensitive prostate cancer (mHSPC), the companies announced on Aug. 21, 2019. Xtandi is currently indicated in the United States for treating patients with castration-resistant prostate cancer (CRPC).

The submission is based on the results from a Phase III clinical trial presented at the 2019 Genitourinary Cancers Symposium (ASCO GU) in February 2019 and published in The Journal of Clinical Oncology in July 2019. The study evaluated the efficacy and safety of Xtandi plus androgen deprivation therapy (ADT) versus ADT plus placebo in men with mHSPC. The primary endpoint of radiographic progression-free survival (rPFS) was met in the study.

“We are pleased to receive the [p]riority [r]eview designation, which reflects the need for more treatment options for men living with metastatic hormone-sensitive prostate cancer,” said Chris Boshoff, MD, PhD, chief development officer, Oncology, Pfizer Global Product Development, in a company press release. “The submission is supported by a strong data package, including two Phase III trials investigating [Xtandi] in men living with this form of prostate cancer.”

“[Xtandi] is a current standard of care in castration-resistant prostate cancer, and we look forward to working with [FDA] to potentially make [the drug] available to men earlier in their prostate cancer journey,” added Andrew Krivoshik, MD, PhD, senior vice-president and Oncology Therapeutic Area head at Astellas, in the press release.


FDA has set a Prescription Drug User Fee Act (PDUFA) date, or target action date, in the fourth quarter 2019.

Source: Pfizer