Two of the biggest pharmaceutical companies, Astellas Pharma Inc. and Pfizer Inc., have been given the green light to introduce a supplemental New Drug Application, XTANDI, as a treatment for men suffering from prostate cancer. The Food and Drug Administration, the U.S. regulatory body, has made this decision following very promising results stemming from a trial series of Phase 3 PROSPER.
Xtandi, or enzalutamide, which was already offered as medication for patients dealing with castration-resistant prostate cancer, has now an extended application and can be prescribed to men with non-metastatic cancer. It means that so far, XTANDI is the sole approved oral solution for both metastatic and non- metastatic cancer.
Jonathan Simons M.D, who is President and CEO of the Prostate Cancer Foundation, said in a press release that “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”.
The Phase 3 PROSPER research data showed that androgen deprivation therapy along with enzalutamide had a considerable impact on reducing the risk of metastasis and death compared to only administering ADT. The average life expectancy improved considerably, from 14.7 months to 36.6.
Some side effects have been noted to occur more frequently, these include: hot flushes, nausea, asthenic conditions, dizziness.
The good news is this treatment could help the ever-growing number of people that are diagnosed each year with prostate cancer. Only in 2018, in the U.S., more than 160.000 new cases have been discovered, making it the second most common type of cancer.
You can find out more information about XTANDI here or by calling 1-855-898-2634.