Lately, Patient Assistance Programs (PAPs), cancer awareness initiatives from governments, growing prevalence of cancer globally are driving strong R&D initiatives and clinical trials are being conducted to find a treatment for several cancer types. Several global firms are increasingly working towards the development of novel treatments for cancer.
Pfizer, a renowned American pharmaceutical company, and Astellas Pharma, a multinational Japanese pharmaceutical company, reportedly announced that their a supplemental new drug application filed for XTANDI® (enzalutamide) has received approval from U.S FDA.
XTANDI would be used to treat patients with mCSPC (metastatic castration-sensitive prostate cancer). Reports cite, in 2019, more than 40,000 men in the U.S. are suffering from mCSPC. The cancer is a type that of prostate cancer that has further spread across other body parts and still responds to a surgical or medical therapy that lowers testosterone.
With the FDA approval, XTANDI has now become the first as well as the only oral therapy in three different types of advanced prostate cancer. Those three cancer types are mCSPC, non-metastatic as well as metastatic castration-resistant prostate cancer (CRPC). FDA approved XTANDI based on the outcomes from the ARCHES study, a randomized Phase 3 trial that examined 1,150 men suffering from mCSPC and met its basic endpoint of rPFS (radiographic progression-free survival).
Andrew Armstrong, M.D., lead investigator of ARCHES, Director of Research in the Duke Cancer Institute’s Center for Prostate and Urologic Cancers and Professor of Surgery, Medicine, Cancer Biology and Pharmacology stated that men suffering from mCSPC (metastatic castration-sensitive prostate cancer) face complex therapy decisions. It is crucial for patients and physicians to possess as much data as possible when deciding from all the available options.
Armstrong further added that the research supporting the approval of FDA and updated therapy guidelines provide patients and physicians with powerful evidence to consider XTANDI as a therapy option for men suffering from this disease.
Senior Vice President and Oncology Therapeutic Area Head at Astellas, Andrew Krivoshik, M.D., Ph.D. stated that XTANDI has been created as a standard of care for men diagnosed with CRPC (castration-resistant prostate cancer). It has also been prescribed to over 420,000 patients across the world since its approval in 2012.
Krivoshik further added that this approval in mCSPC (metastatic castration-sensitive prostate cancer) means doctors can now provide XTANDI to men earlier in their journey of advanced prostate cancer therapy.
Source credit: https://www.pfizer.com/news/press-release/press-release-detail/xtandi_enzalutamide_approved_by_u_s_fda_for_the_treatment_of_metastatic_castration_sensitive_prostate_cancer