'We are pleased to receive the Priority Review designation, which reflects the need for more treatment options for men living with metastatic hormone-sensitive prostate cancer
,' said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology, Pfizer Global Product Development.
Chemohormonal Therapy in Metastatic Hormone-Sensitive Prostate Cancer
: Long-Term Survival Analysis of the Randomized Phase III E3805 CHAARTED Trial.
ADT: androgen-deprivation therapy; CRPC: castration-resistant prostate cancer; D: docetaxel; HSPC: hormone-sensitive prostate cancer
; OS: overall survival.
In addition to the Phase III trial ARAMIS in men with nmCRPC, darolutamide is also being investigated in a Phase III study in metastatic hormone-sensitive prostate cancer
Pfizer and Astellas Pharma announced today results from the Phase 3 ARCHES trial in men with metastatic hormone-sensitive prostate cancer
. Prostate cancer is considered metastatic once the cancer has spread outside of the prostate gland to other parts of the body.
M2 PHARMA-June 3, 2019-Erleada Significantly Improved Overall Survival and Radiographic Progression-Free Survival in Patients with Metastatic Hormone-Sensitive Prostate Cancer
Astellas Pharma (ALPMY) and Pfizer (PFE) announced that the Phase 3 ARCHES trial evaluating XTANDI plus androgen deprivation therapy (ADT) in men with metastatic hormone-sensitive prostate cancer
met its primary endpoint, significantly improving radiographic progression-free survival versus ADT alone.
With the amendments to ARCHES and EMBARK, we will be able to evaluate the potential of XTANDI for men with hormone-sensitive prostate cancer
sooner, including for those with non-metastatic disease in which there are no currently approved oral treatment options.'
There have been studies that suggest hormone-sensitive prostate cancer
with oligometastasis may well be eligible for a similar approach given the remarkably favourable prognosis observed in men with oligometastasis.