FDA Grants Xtandi Priority Review for Certain Patients with Prostate Cancer

The Food and Drug Administration (FDA) has accepted a priority review for Xtandi (enzalutamide) to treat patients with non-metastatic castration-sensitive prostate cancer (nmCSPC) with high-risk biochemical recurrence (BCR), according to Pfizer and Astellas Pharma Inc.

Priority reviews, which speed up the FDA’s review and potential approval of a therapy, are granted to medicines that can make significant advancements for severe diseases, as is the case with Xtandi for this prostate cancer subset. The anticipated time that this approval decision will be released is said to be in Q4 2023, according to the Prescription Drug User Fee Act.

"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,” Dr. Chris Boshoff, Chief Oncology Research and Development Officer, Executive Vice President of Pfizer, said in the press release.

The phase 3 randomized EMBARK trial evaluated more than 1,000 patients with nmCSPC with high-risk BCR.

The New Drug Application was based on a previous phase 3 EMBARK trial, which focused on patients either receiving Xtandi combined with leuprolide (355 patients); Xtandi being used as a monotherapy (355 patients); placebo plus leuprolide (358 patients). Results measured an endpoint for metastasis- free survival, as well as a reduction in the risk of metastasis and death when it came to placebo combined with leuprolide. Findings showed a decreased risk within 58%.

"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,” explained Dr. Ahsan Arozullah, Senior Vice President and Head of Oncology Development, Astellas, in the release.

Overall, safety remained consistent and stayed the same throughout the study of this treatment. The common side effects when it came to the Xtandi plus leuprolide dose were fatigue, hot flush and arthralgia. When it came to the Xtandi monotherapy, the side effects included fatigue, gynecomastia and arthralgia.

Xtandi is being reviewed throughout the Real-Time Oncology Review (RTOR) program, alongside Project Orbis, which are part of the FDA that increase the process of accepted a medication for treatment.

Data from the EMBARK trial is being looked into to ensure that Xtandi may be accessible starting in 2023 and within the future.

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