Pfizer and Astellas’ prostate cancer drug approved

By admin Dec4,2023

This was following FDA expedited development and review programs (Priority Review designation, Fast Track designation, Real-time Oncology Review), based on results from the phase 3 Embark trial​.

With this approval, Xtandi becomes the first and only androgen receptor signaling inhibitor approved by the FDA for the treatment of patients with nonmetastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR).

Patients with nmCSPC with high-risk BCR may be treated with Xtandi with or without a gonadotropin-releasing hormone (GnRH) analog therapy.

In their research, the companies found that those men who have undergone definitive prostate cancer treatment, including radical prostatectomy, radiotherapy or both, an estimated 20-40% will experience biochemical recurrence (BCR) within ten years. About nine out of ten men with high-risk BCR will develop metastatic disease and one in three will die as a result of their metastatic prostrate cancer.

Previously treated prostate cancer

“For patients who were previously treated for prostate cancer and had achieved remission, only to later receive the distressing news of disease recurrence with a risk of metastasis, the emotional toll can be profound,” said Courtney Bugler, president, and CEO of ZERO Prostate Cancer.

“This approval of Xtandi is a promising treatment option for the community, offering a ray of hope to patients and their caregivers during these challenging times.” 

Neal Shore is chief medical officer of strategic innovation and pharmacy at GenesisCare, USA, and director of the Carolina Research Center and primary investigator for the trial.

By admin

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