Astellas, Pfizer score Xtandi FDA approval for non-metastatic CRPC


Xtandi FDA approval : Astellas Pharma and Pfizer said that the US Food and Drug Administration (FDA) has expanded the approval of cancer drug Xtandi (enzalutamide) to be used for treatment of men with non-metastatic castration-resistant prostate cancer (CRPC).

The earlier Xtandi FDA approval, which came in 2014, was for the treatment of men with castration-resistant prostate cancer who are chemotherapy-naïve. Prior to that in 2012, the cancer drug was approved the treatment of metastatic CRPC in patients who were previously subjected to docetaxel.

Xtandi, which is an androgen receptor inhibitor, is now the first oral medication to be approved for treatment of non-metastatic and metastatic CRPC.

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Commenting on the latest Xtandi FDA approval for non-metastatic CRPC, Jonathan Simons –  Prostate Cancer Foundation President and CEO, said: “With today’s approval, there is now a new option for men with non-metastatic CRPC, who are in between the failure of androgen deprivation therapy resulting in CRPC and the onset of metastatic disease.

“As a foundation that drives research aimed at improving patient outcomes, it is exciting to see approvals like this, which are vital to help address unmet patient needs.”

Pfizer announces Xtandi FDA approval for non-metastatic CRPC.

Pfizer announces Xtandi FDA approval for non-metastatic CRPC. Photo courtesy of w:ru:jenix89 (talk | contribs) and

Xtandi’s approval for a new indication was driven by the results from the PROSPER phase 3 trial, which proved that Xtandi plus androgen deprivation therapy (ADT) considerably brought down the risk of developing metastasis or death. This was shown in comparison to androgen deprivation therapy alone in men having non-metastatic CRPC.

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Andy Schmeltz – global president, Oncology, Pfizer, said that as CRPC is difficult to treat as it advances, decreasing the chances of disease progression is a major treatment goal in the type of cancer.

Commenting further on the latest Xtandi FDA approval for non-metastatic castration-resistant prostate cancer, Andy Schmeltz said: “With Xtandi, men with CRPC now have a clinically proven treatment option that reduces the risk of metastasis. This approval delivers on the potential for Xtandi to help men at an earlier stage of the disease, and we are continuing to evaluate the medicine in an extensive development program across additional prostate cancer populations.”

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