XTANDI (enzalutamide) is now approved by the U.S Food and Drug Administration for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC), also used for the treatment of both metastatic and non-metastatic castration-resistant prostate cancer.
Two big biopharmaceutical companies; Pfizer Incorporation in New York and Astellas Pharma announced that they gained the U.S Food and Drug Administration (FDA) approval for a new supplemental drug application for XTANDI (enzalutamide) for patients with mCSPC.
According to the recent estimation, more than 40,000 men in the United States are suffering from terrible metastatic hormone-sensitive prostate cancer which is also known as metastatic castration-sensitive prostate cancer. It is the type of cancer that gets spread beyond the prostate and still responds to the androgen deprivation therapy (ADT) or other medical and surgical treatments that lowers the level of testosterone.
As XTANDI gets FDA approval, it the first and only drug that has been approved by the FDA to date. The FDA approved XTANDI in three different types of prostate cancer which include mCSPC as well as both metastatic prostate cancer and non-metastatic castration-resistant prostate. The approval was given on the basis of the randomized Phase 3 clinical study from ARCHIES.
In this study, 1,150 men living with mCSPC were evaluated and this study reaches the endpoint of radiographic progression-free survival (rPFS). The radiographic progression-free survival is highly linked with the overall survival, serves as an indicator for treatment results.
The director of research in the Duke Cancer Institute’s Center and the lead investigator of ARCHIES, Andrew Armstrong discussed the complications faced by the physicians and the patients suffering from mCSPC and discussed the need for more learning and having more information for the decision of the treatment.
Men with mCSPC are facing difficulties in treatment decisions and it’s important to have all the possible information for the better treatment decision from all the options available. Moreover, he said that the research supporting the approval by FDA providing the healthcare physicians and the patients with the pieces of evidence for considering XTANDI (enzalutamide) for the treatment of men suffering from mCSPC.
Data from the ARCHIES study showed that the use of XTANDI with ADT significantly lowers the radiographic progression and death rate. The safety analysis of the clinical trials shows the safe profile of XTANDI. XTANDI has been declared as the standard of the care for men with both metastatic and non-metastatic castration-resistant prostate cancer. The approval leads the basis for offering XTANDI treatment to the patients earlier in the treatment process.
Some warnings and precautions are subscribed for XTANDI because some issues were observed in patients using XTANDI such as seizures, hypersensitivity, posterior reversible encephalopathy syndrome, Ischemic heart diseases, hypertension, embryo-fetal toxicity, and some other adverse reactions.
XTANDI is currently being evaluated in EMBARK trial, in patients with high-risk of non-metastatic castration-sensitive prostate cancer as it is the part of the ongoing commitment of Pfizer and Astellas to the clinical of the new product; enzalutamide. Moreover, The Pharmaceutical and Medical Agency (PMDA) and The European Medicines Agency (EMA) are also evaluating XTANDI for metastatic hormone-sensitive prostate cancer patients.