Prostate Cancer

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...

Officials with the FDA approved darolutamide (Nubeqa, Bayer) this week, under the federal agency’s Priority Review designation. Darolutamide is an androgen receptor inhibitor (ARi) for the treatment of patients with non-metastatic castration-resistant prostate cancer. The FDA's approval is based on the phase 3 ARAMIS trial evaluating darolutamide plus androgen deprivation therapy (ADT), which demonstrated a highly significant improvement in the primary efficacy endpoint of metastasis-free survival (MFS). MFS had a medium of 40.4 months verses 18.4 months for placebo plus ADT. During the ARAMIS trial, both arms showed a 9% discontinuation rate due to adverse events, the most frequent in darolutamide versus placebo were fatigue (16% vs. 11%), pain in extremity (6% vs. 3%) and rash (3% vs. 1%). "With the approval of Nubeqa, we now have a new therapy that extends MFS and allows physicians greater flexibility to treat men living with nmCRPC," said Robert LaCaze, Member of ...

Darolutamide ( Nubeqa , Bayer) has been approved by the US Food and Drug Administration (FDA) for use in the treatment of nonmetastatic castration-resistant prostate cancer (nmCRPC). The approval was granted under the FDA's priority review and came 3 months ahead of the target FDA action date. It is based on results from the phase 3 ARAMIS trial (n = 1509), which showed a significant improvement in the primary endpoint of metastasis-free survival (MFS). The ARAMIS trial results were presented in February 2019 at the Genitouirinary Cancers Symposium and were published online in the New England Journal of Medicine, as reported at the time by Medscape Medical News . New Endpoint, New Clinical Space MFS is a new endpoint in a new clinical space — until last year, no drugs had been approved for use in nmCRPC. Now there are three — darlutamide joins two other antiandrogen products that have been approved this indication, also on the basis of improved MFS. MFS is determined on...

Darolutamide ( Nubeqa , Bayer) has been approved by the US Food and Drug Administration (FDA) for use in the treatment of nonmetastatic castration-resistant prostate cancer (nmCRPC). The approval was granted under the FDA's priority review and came 3 months ahead of the target FDA action date. It is based on results from the phase 3 ARAMIS trial (n = 1509), which showed a significant improvement in the primary endpoint of metastasis-free survival (MFS). The ARAMIS trial results were presented in February 2019 at the Genitouirinary Cancers Symposium and were published online in the New England Journal of Medicine, as reported at the time by Medscape Medical News . New Endpoint, New Clinical Space MFS is a new endpoint in a new clinical space — until last year, no drugs had been approved for use in nmCRPC. Now there are three — darlutamide joins two other antiandrogen products that have been approved this indication, also on the basis of improved MFS. MFS is determined on...

Darolutamide ( Nubeqa , Bayer) has been approved by the US Food and Drug Administration (FDA) for use in the treatment of nonmetastatic castration-resistant prostate cancer (nmCRPC). The approval was granted under the FDA's priority review and came 3 months ahead of the target FDA action date. It is based on results from the phase 3 ARAMIS trial (n = 1509), which showed a significant improvement in the primary endpoint of metastasis-free survival (MFS). The ARAMIS trial results were presented in February 2019 at the Genitouirinary Cancers Symposium and were published online in the New England Journal of Medicine, as reported at the time by Medscape Medical News . New Endpoint, New Clinical Space MFS is a new endpoint in a new clinical space — until last year, no drugs had been approved for use in nmCRPC. Now there are three — darlutamide joins two other antiandrogen products that have been approved this indication, also on the basis of improved MFS. MFS is determined on...

In the modern era of advanced imaging and genomics testing, the digital rectal exam (DRE) is still an "important" and clinically relevant prognostic test for prostate cancer , conclude the authors of a new observational study. The role of the DRE, which is a "historic" method of staging the disease, has been "uncertain" in recent years, acknowledge the investigators, led by Jenna Borkenhagen, MD, a radiation oncologist at the Medical College of Wisconsin in Milwaukee. That's because of the availability of other prognostic tools such as the 4K Score, Decipher, and MRI, they say. Plus, no one has studied the question of DRE's usefulness in a more modern setting. For a long time, the DRE served, along with a prostate-specific antigen (PSA) value and a Gleason score, as the bedrock for assessing prostate cancer prognosis, which influences treatment decisions. The new observational, retrospective study shows that clinical stage classification via D...

A new generation of potent prostate cancer drugs has dramatically extended survival for patients with advanced prostate cancer. But prostate tumors are finding new ways of resisting these treatments, creating a need for new treatment options. In a new study published today , researchers at Fred Hutchinson Cancer Research Center discovered that when aggressive prostate tumors turn off the receptor, their source for growth-fueling hormones, they ramp up a different growth-promoting system. When the scientists targeted this pathway in mouse models of prostate cancer, the mice lived longer. “We figured out the mechanism by which [tumors lacking androgen receptor continue growing] … and that may be a therapeutic vulnerability,” said Hutch prostate cancer researcher and oncologist Dr. Andrew Hsieh , who led the study, which was published in the journal Science Translational Medicine. Hsieh also treats patients with prostate cancer at the University of Washington Medical Center. In the sh...

Darolutamide ( Nubeqa , Bayer) has been approved by the US Food and Drug Administration (FDA) for use in the treatment of nonmetastatic castration-resistant prostate cancer (nmCRPC). The approval was granted under the FDA's priority review and came 3 months ahead of the target FDA action date. It is based on results from the phase 3 ARAMIS trial (n = 1509), which showed a significant improvement in the primary endpoint of metastasis-free survival (MFS). The ARAMIS trial results were presented in February 2019 at the Genitouirinary Cancers Symposium and were published online in the New England Journal of Medicine, as reported at the time by Medscape Medical News . New Endpoint, New Clinical Space MFS is a new endpoint in a new clinical space — until last year, no drugs had been approved for use in nmCRPC. Now there are three — darlutamide joins two other antiandrogen products that have been approved this indication, also on the basis of improved MFS. MFS is determined on...

[unable to retrieve full-text content] FDA Approves Prostate Cancer Treatment Nubeqa    Cancer Therapy Advisor FDA Approves Bayer's Nubeqa® (darolutamide), a New Treatment for Men with Non-Metastatic Castration-Resistant    Prostate Cancer Foundation FDA Approves Nubeqa for Prostate Cancer    Curetoday.com View full coverage on Google News https://ift.tt/2Zj5DNc

In the modern era of advanced imaging and genomics testing, the digital rectal exam (DRE) is still an "important" and clinically relevant prognostic test for prostate cancer , conclude the authors of a new observational study. The role of the DRE, which is a "historic" method of staging the disease, has been "uncertain" in recent years, acknowledge the investigators, led by Jenna Borkenhagen, MD, a radiation oncologist at the Medical College of Wisconsin in Milwaukee. That's because of the availability of other prognostic tools such as the 4K Score, Decipher, and MRI, they say. Plus, no one has studied the question of DRE's usefulness in a more modern setting. For a long time, the DRE served, along with a prostate-specific antigen (PSA) value and a Gleason score, as the bedrock for assessing prostate cancer prognosis, which influences treatment decisions. The new observational, retrospective study shows that clinical stage classification via D...

The Food and Drug Administration granted a priority review to Nubeqa for the treatment of men with non-metastatic castration-resistant prostate cancer. BY Kristie L. Kahl The Food and Drug Administrated (FDA) approved Nubeqa (darolutamide) under a priority review to treat men with non-metastatic castration-resistant prostate cancer, according to Bayer, the drug’s manufacturer. The agency based its approval on data from the randomized, double-blind, placebo-controlled, multi-center phase 3 ARAMIS trial – designed to evaluate Nubeqa, an androgen receptor inhibitor, plus androgen deprivation therapy in 1,509 patients with non-metastatic castration-resistant prostate cancer. The trial showed a significant improvement in metastasis-free survival – the measure of time from diagnosis or treatment to appearance of a distant metastasis (cancer that has spread from the original (primary) tumor to distant organs or distant lymph nodes). The median metastasis-free survival was 40.4 months comp...

Ray Painter, MD Mark Painter I plan to work with a friend of mine in an unaffiliated urology group to perform a cystoprostatectomy, ileal loop, and lymph node dissection. How should I code for the following two scenarios? First, if I perform the prostatectomy and charge for the prostatectomy and then assist on the rest of the surgery; and second, if I perform the lymph node dissection and then assist on the rest of the surgery. The codes available to report the primary procedure of cystectomy, 51590 (Cystectomy, complete, with ureteroileal conduit or sigmoid bladder, including intestine anastomosis) and 51595 (Cystectomy, complete, with ureteroileal conduit or sigmoid bladder, including intestine anastomosis; with bilateral pelvic lymphadenectomy, including external iliac, hypogastric, and obturator nodes), include by description cystectomy and loop. As one can see from the description, the primary procedure can be reported with or without nodes. Also from the Painters:...

ORION CORPORATION PRESS RELEASE 31 JULY 2019 at 7.30 EEST                        U.S. FDA approves darolutamide, a new treatment for men with non-metastatic castration-resistant prostate cancer (nmCRPC) Approval of darolutamide is based on the Phase III ARAMIS trial evaluating the efficacy and safety of darolutamide plus androgen deprivation therapy (ADT) compared to placebo plus ADT. Darolutamide was approved under the FDA Priority Review designation . The U.S. Food and Drug Administration (FDA) has granted approval to darolutamide, a non-steroidal androgen receptor inhibitor (ARi), under the brand name Nubeqa®. The FDA approval is for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) and is based on the Phase III ARAMIS trial showing darolutamide plus androgen deprivation therapy (ADT) demonstrated a highly significant improvement in the ...

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...

Prostate cancer occurs in the prostate — a small walnut-shaped gland in men that produces the seminal fluid that nourishes and transports sperm. The causes of prostate cancer are largely unknown. However, certain things can increase your risk of developing the condition. No one knows how to prevent the disease but r ecent research suggests a particular compound found in coffee may inhibit the growth of the disease. Japanese scientists have studied the effects of two compounds found in coffee, kahweol acetate and cafestol, on prostate cancer cells and in animals, where they were able to inhibit growth in cells which are resistant to common anti-cancer drugs such as Cabazitaxel. The researchers initially tested six compounds, naturally found in coffee, on the proliferation of human prostate cancers cells in vitro (i.e. in a petri-dish). They found that cells treated with kahweol acetate and cafestol grew more slowly than controls. They then tested these compounds on prostate can...

ORION CORPORATION PRESS RELEASE 31 JULY 2019 at 7.30 EEST                        U.S. FDA approves darolutamide, a new treatment for men with non-metastatic castration-resistant prostate cancer (nmCRPC) Approval of darolutamide is based on the Phase III ARAMIS trial evaluating the efficacy and safety of darolutamide plus androgen deprivation therapy (ADT) compared to placebo plus ADT. Darolutamide was approved under the FDA Priority Review designation . The U.S. Food and Drug Administration (FDA) has granted approval to darolutamide, a non-steroidal androgen receptor inhibitor (ARi), under the brand name Nubeqa®. The FDA approval is for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) and is based on the Phase III ARAMIS trial showing darolutamide plus androgen deprivation therapy (ADT) demonstrated a highly significant improvement in the ...