FDA approves Pfizer & Astellas’ Xtandi for earlier prostate cancer treatment setting
Astellas Pharma Inc. and Pfizer Inc. announced that the companies received an approval by the US Food and Drug Administration (FDA) of a supplemental New Drug Application for Xtandi (enzalutamide), following FDA expedited development and review programmes (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 signalling 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.
Of men who have undergone definitive prostate cancer treatment, including radical prostatectomy, radiotherapy, or both, an estimated 20-40% will experience biochemical recurrence (BCR) within 10 years. About nine out of 10 men with high-risk BCR will develop metastatic disease, and one in three will die as a result of their metastatic 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.”