FDA accepted Pfizer and Astellas’ supplemental New Drug Application (sNDA) for Xtandi, expanding its indication to include patients with non-metastatic castration-sensitive prostate cancer (nmCSPC) with high-risk biochemical recurrence (BCR)


FDA grants priority review for Xtandi. (Credit: Pfizer Inc.)

Pfizer and Astellas Pharma announced that the US Food and Drug Administration (FDA) has granted priority review for their prostate cancer drug Xtandi (enzalutamide).

The US health regulator accepted their supplemental New Drug Application (sNDA) for Xtandi and granted a Prescription Drug User Fee Act (PDUFA) date of Q4 2023.

Xtandi was previously approved to treat metastatic castration-sensitive prostate cancer mCSPC, also known as metastatic hormone-sensitive prostate cancer (mHSPC).

The sNDA expands Xtandi’s indication to include patients with non-metastatic castration-sensitive prostate cancer (nmCSPC) with high-risk biochemical recurrence (BCR).

The drug is currently approved in more than 100 countries, including the US, European Union (EU) and Japan, for the treatment of one or more indications.

The US FDA is currently reviewing the companies’ sNDA under its Real-Time Oncology Review (RTOR) programme and Project Orbis initiatives.

Pfizer executive vice president and chief oncology research and development officer Chris Boshoff said: “The FDA’s granting of a Priority Review designation reinforces the need to bring new treatment options for patients with high-risk biochemical recurrent nmCSPC.

“We believe the EMBARK data demonstrate the potential of Xtandi, if approved, to help patients earlier in the course of their disease, building on Xtandi’s foundation as an existing standard of care in prostate cancer.”

Pfizer and Astellas submitted the sNDA for Xtandi, based on results from the Phase 3 EMBARK trial, which evaluated patients with nmCSPC with high-risk BCR.

In the study, the participants were divided into three study groups, to receive either a combination of Xtandi plus leuprolide, or placebo plus leuprolide, or Xtandi alone.

The Phase 3 study met its primary endpoint of metastasis-free survival (MFS) for the Xtandi plus leuprolide arm, with a 58% reduction in the risk of metastasis or death compared to placebo plus leuprolide.

Xtandi showed an overall safety profile that was consistent with the known safety profile.

The most common adverse events include fatigue, hot flush, gynecomastia, and arthralgia.

Xtandi, in combination with leuprolide or as monotherapy, has not been approved by any regulatory authority for the treatment of patients with nmCSPC with high-risk BCR.

Astellas senior vice president and oncology development head Ahsan Arozullah said: “Biochemical recurrence can be one of the first indicators that prostate cancer is returning or will spread, particularly among those patients that experience rapid PSA doubling times.

“The goal of treatment in this setting is to delay the spread of the cancer cells to other parts of the body. The addition of Xtandi to leuprolide has shown greater clinical benefit compared to placebo plus leuprolide, and we look forward to working with the FDA and other global regulatory authorities to bring Xtandi to these patients.”