According to a press release from American pharmaceutical giant Pfizer, Inc. the FDA recently agreed to review a supplemental New Drug Application for Xtandi.
Xtandi was first approved for the treatment of castration-resistant prostate cancer in the summer of last year, but now co-developers Pfizer and Astellas Pharma want to get it approved for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) as well.
About Metastatic Hormone-Sensitive Prostate Cancer
Metastatic hormone-sensitive prostate cancer is a form of prostate cancer that has spread throughout the body, but continues to respond to androgen-deprivation therapies. Androgens are hormones involved in male development and reproductive activity. However, androgens can also stimulate the growth of cancer cells located in the prostate.
Androgen-deprivation therapies (sometimes called hormone therapies) may be employed in patients who are non-responsive to, or are unable to receive radiation therapies or surgery. These therapies, while effective in treating certain prostate cancers, can carry a host of potentially serious side effects including anemia, osteoporosis, and elevated cholesterol.
Though a considerable majority of cases of prostate cancer are non-fatal, the condition can pose significant health challenges — and indeed, while rare, some prostate cancers do result in early mortality.
About Xtandi and the Supplemental New Drug Application
Drugs already approved in the United States for the treatment of a certain condition can apply for supplementary New Drug Applications (sNDA), which allow for companies to bring one drug to the market for multiple conditions as new research becomes available.
The sNDA also includes a Priority Review designation, which is offered to drug developers on a case-by-case basis. Drug candidates that receive a Priority Review designation are entitled to an accelerated FDA review process — receiving a ruling from the governing body in as little as six months, as opposed to the average ten months of standard deliberation.
Pfizer and Astellas’ decision to apply for an sNDA and Priority Review was based on a successful phase 3 study of a combination of Xtandi and androgen-deprivation therapy in men with mHSPC. Men receiving the combination therapy proved to enjoy greater degrees of radiographic progression-free survival than patients receiving only ADT and a placebo.
Because of the accelerated timeline offered by Priority Review, a ruling on Xtandi’s use in men with mHSPC is likely by summer of next year.
Because cancers are so diverse, it can be difficult to treat different forms with the same therapy. What do you think of this exciting development? Share your thoughts with Patient Worthy!
