FDA approves new drug application for anti-cancer drug Xtandi

recentlyPfizer and partner Astellas jointly announced that the U.SFoodDrug(
FDA() has approved a supplementtoenew drug(application, expanding its current indications to include non-metastatic resistance to prostate cancer (nmCRPCPC) male patientsin the United States, Xtandi was first approved in 2012 for the treatment of metastatic CRPC patients who had previously undergone dositarace chemotherapy, and in 2014 was approved for metastatic CRPC patients with initial chemotherapy treatmentXtandi is jointly developed and sold by Astellas and Medivation, now Pfizer'scompany
To date, Xtandi has sold in more than 70 markets worldwideXtandi is a novel, daily oral androgen receptor signaling inhibitor that inhibits multiple steps in the androgen receptor signaling pathway and is designed to interfere with testosterone's ability to bind to prostate cancer cells, has been shown to reduce the growth of cancer cells and induce tumor cell deathTestosterone is a male hormone that inflames the growth of prostate cancer cellsstudiesdata show that Xtandi and ADT combination therapy significantly reduced the risk of metastasis or death by 71% compared to ADT alone: 23% of patients in the Xtandi and ADT combined treatment groups had the disease of metastasis or death, compared with 49% in the ADT alone treatment group The main endpoint of the study was no metastasis (MFS), with Xtandi and ADT in the combined treatment group at 36.6 months and ADT alone for 14.7 months, extending it by up to 22 months (HR?0.29.25 CI: 0.24-0.35), p 0.001) the timing of the first use of new anti-tumor therapy (TTA), Xtandi achieved a statistically significant delay in the adjoining therapy group (median TTA: 39.6 months vs 17.7 months; HR s.21.21(95%CI: 0.17-0.26) ;p 0.0001) compared to the ADT individual treatment group Total Lifetime Data (OS) is not yet mature at the time of the final MFS analysis () adverse events In this study, the most common adverse reactions in the Xtandi and ADT combination therapy group were more frequent (-2%) (-10%) compared to the ADT treatment group, including: weakness (40 percent vs 20 percent), hot flash (13 percent vs 7.7 percent), hypertension (12 percent vs 5.2 percent), dizziness (12 percent vs 5.2 percent), nausea (11 percent vs 5.2 percent), nausea (11 percent) and 1.1 vs 1.1 incidence of adverse reactions at level 3 or higher, death from adverse events, and discontinuation of adverse events, Xtandi and ADT combined treatment groups were 31%, 3.4%, 9.4%, and ADT treated groups were 23%, 0.6% and 6%, respectively