Prostate Cancer

The FDA has approved darolutamide (Nubeqa) for the treatment of patients with nonmetastatic castration-resistant prostate cancer. 1 The approval of the androgen receptor inhibitor is based on data from the phase III ARAMIS trial, in which darolutamide in combination with androgen deprivation therapy (ADT) led to a 59% reduction in the risk of metastases or death compared with placebo/ADT in this patient population (HR, 0.41; 95% CI, 0.34-0.50; 2-sided, P <.0001). 2,3 Moreover, the median metastasis-free survival (MFS) was 40.4 months with the addition of darolutamide versus 18.4 months with placebo/ADT at a median follow-up of 17.9 months.  The approval took place 3 months ahead of the agency's action date, stated Bayer, which jointly manufactures darolutamide with Orion Corporation, in a press release.  "Patients at this stage of prostate cancer typically don't have symptoms of the disease. The overarching goals of treatment in this setting are to delay the s...

and purpose: To assess the efficacy and safety of salvage stereotactic body radiotherapy (SBRT) in patients with biopsy-proven local prostate cancer recurrence after radiotherapy. Between April 2010 and January 2017, 100 patients were included in 7 centers. Disease extension was assessed by pelvic multiparametric magnetic resonance imaging and choline positron emission tomography in 87% and 94% of patients, respectively. The median time interval between the two treatments was 7.5 years (range, 2-18). Median PSA at recurrence was 4.3 ng/mL (range, 2-38). Median SBRT dose was 36 Gy (range, 25-36.25) in 6 fractions (range, 5-6), every other day. Thirty-four percent of patients were treated by androgen deprivation therapy for a median duration of 12 months. Toxicity was assessed according to CTCAE v.4.03. Median follow-up was 29.3 months (range, 4-91). Second biochemical recurrence-free survival rate at 3 years was 55% [95% CI: 42%-66%]. The initial D'Amico group, time interval after...

WHIPPANY, N.J., July 30, 2019 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) today approved Nubeqa® (darolutamide), an androgen receptor inhibitor (ARi), for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC).  The FDA approval is based on the Phase III ARAMIS trial evaluating Nubeqa plus androgen deprivation therapy (ADT), which demonstrated a highly significant improvement in the primary efficacy endpoint of metastasis -free survival (MFS), with a median of 40.4 months versus 18.4 months for placebo plus ADT (p<0.0001). MFS is defined as the time from randomization to the time of first evidence of blinded independent central review (BICR)-confirmed distant metastasis or death from any cause within 33 weeks after the last evaluable scan, whichever occurred first. Nubeqa was approved under the FDA’s Priority Review designation, which is reserved for medicines that may provide significant improvements in the safety or effect...

Some 5,400 men are diagnosed with prostate cancer in Finland every year. Although in most cases prostate cancer can be cured, approximately 900 men every year die of it. Treatment recommendations for prostate cancer are largely based on the cancer's stage (TNM classification), the cancer's aggressiveness determined from a prostate biopsy (the Gleason score), and prostate-specific antigen (PSA) obtained from a blood test, as well as the risk categorization determined on the basis of these. The treatment options for a local, low-risk prostate cancer are established and the prognosis is good. On the other hand, the prognosis for a higher-risk, locally spread or metastasized cancer is poorer, and there is no consensus on the treatments due to a lack of sufficient research data. In connection to the surgical removal of the prostate, the cancer may be found to have extended to the surface of the removed prostate or to have already spread through the capsule surrounding the prosta...

WHIPPANY, N.J., July 30, 2019 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) today approved Nubeqa® (darolutamide), an androgen receptor inhibitor (ARi), for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC).  The FDA approval is based on the Phase III ARAMIS trial evaluating Nubeqa plus androgen deprivation therapy (ADT), which demonstrated a highly significant improvement in the primary efficacy endpoint of metastasis -free survival (MFS), with a median of 40.4 months versus 18.4 months for placebo plus ADT (p<0.0001). MFS is defined as the time from randomization to the time of first evidence of blinded independent central review (BICR)-confirmed distant metastasis or death from any cause within 33 weeks after the last evaluable scan, whichever occurred first. Nubeqa was approved under the FDA’s Priority Review designation, which is reserved for medicines that may provide significant improvements in the safety or effect...

WHIPPANY, N.J., July 30, 2019 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) today approved Nubeqa® (darolutamide), an androgen receptor inhibitor (ARi), for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC).  The FDA approval is based on the Phase III ARAMIS trial evaluating Nubeqa plus androgen deprivation therapy (ADT), which demonstrated a highly significant improvement in the primary efficacy endpoint of metastasis -free survival (MFS), with a median of 40.4 months versus 18.4 months for placebo plus ADT (p<0.0001). MFS is defined as the time from randomization to the time of first evidence of blinded independent central review (BICR)-confirmed distant metastasis or death from any cause within 33 weeks after the last evaluable scan, whichever occurred first. Nubeqa was approved under the FDA’s Priority Review designation, which is reserved for medicines that may provide significant improvements in the safety or effect...

WHIPPANY, N.J., July 30, 2019 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) today approved Nubeqa® (darolutamide), an androgen receptor inhibitor (ARi), for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC).  The FDA approval is based on the Phase III ARAMIS trial evaluating Nubeqa plus androgen deprivation therapy (ADT), which demonstrated a highly significant improvement in the primary efficacy endpoint of metastasis -free survival (MFS), with a median of 40.4 months versus 18.4 months for placebo plus ADT (p<0.0001). MFS is defined as the time from randomization to the time of first evidence of blinded independent central review (BICR)-confirmed distant metastasis or death from any cause within 33 weeks after the last evaluable scan, whichever occurred first. Nubeqa was approved under the FDA’s Priority Review designation, which is reserved for medicines that may provide significant improvements in the safety or effect...