GenomeDx Announces Inclusion of Decipher Genomic Testing in NCCN Guidelines for Prostate Cancer

Excerpt:

“GenomeDx Biosciences, a leader in the field of urologic cancer genomics, today announced that its Decipher® Prostate Biopsy and Decipher Prostate RP molecular assays for prostate cancer are now included in the 2018 National Comprehensive Cancer Network® (NCCN) Clinical Practice Guidelines in Oncology [Version 1.2018].

“The NCCN Guidelines are the recognized clinical standard for cancer care, and are developed and revised by a panel of expert physicians from 27 leading U.S. cancer centers. The panel revises recommended practice guidelines according to current evidence and advances in cancer care.”

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FDA Approves New Treatment for a Certain Type of Prostate Cancer Using Novel Clinical Trial Endpoint

Excerpt:

“The U.S. Food and Drug Administration today approved Erleada (apalutamide) for the treatment of patients with prostate cancer that has not spread (non-metastatic), but that continues to grow despite treatment with hormone therapy (castration-resistant). This is the first FDA-approved treatment for non-metastatic, castration-resistant prostate cancer.”

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ZYTIGA® (abiraterone acetate) Plus Prednisone Approved for Treatment of Earlier Form of Metastatic Prostate Cancer

Excerpt:

“The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved a new indication for ZYTIGA® (abiraterone acetate) in combination with prednisone for the treatment of patients with metastatic high-risk castration-sensitive prostate cancer (CSPC). The approval is based on Phase 3 data from the pivotal LATITUDE clinical trial, which found that in patients with metastatic high-risk CSPC, ZYTIGA® in combination with prednisone reduced the risk of death by 38 percent compared to placebos.”

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Strong Data Lift Profile of J&J’s Cancer Drug Apalutamide

Excerpt:

“Adding Johnson & Johnson’s experimental prostate cancer drug apalutamide to standard treatment helped delay the development of metastases in patients with non-metastatic castration-resistant disease by just over 2 years, results from a Phase 3 study showed.”

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Pfizer’s Xtandi Delays Prostate Cancer Spread in Early Stage Disease

Excerpt:

“Use of Xtandi in early stage prostate cancer on top of standard hormone therapy reduced the risk of disease spreading or death by 71 percent compared with hormone therapy alone, study results that could lead to significantly increased sales of the Pfizer Inc and Astellas Pharma Inc medicine.

“The data from a highly anticipated study released on Monday showed that it took 36.6 months for the disease to spread to other parts of the body in patients who received Xtandi plus androgen deprivation therapy (ADT), a measure known as median metastasis-free survival. That compared with 14.7 months for ADT alone, a highly statistically significant difference of nearly two years.”

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Update Sustains OS Benefit of Chemohormonal Therapy in High-Volume Prostate Cancer

Excerpt:

“Adding docetaxel to androgen-deprivation therapy (ADT) improved overall survival (OS) by nearly 17 months in men with high-volume metastatic hormone-sensitive prostate cancer. Investigators for the multicenter phase III CHAARTED trial noted that the survival benefit did not extend to men with low-volume disease.

“In this updated analysis, the median OS was 57.6 months for the chemohormonal therapy arm versus 47.2 months for ADT alone (hazard ratio [HR], 0.72; 95% CI, 0.59-0.89; P = .0018) at a median follow-up of 53.7 months. For patients with high-volume disease (n = 513), the median OS was 51.2 months with chemohormonal therapy versus 34.4 months with ADT alone (HR, 0.63; 95% CI, 0.50-0.79; P <.001).”

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High-Fat Diet May Fuel Spread of Prostate Cancer

Excerpt:

“Obesity is linked to prostate cancer, scientists know, but it’s not clear why. On Monday, researchers reported a surprising connection.

“When prostate cancers lose a particular gene, they become tiny fat factories, a team at Beth Israel Deaconess Medical Center in Boston reported in a paper published in Nature Genetics.

“Then the cancers spread from the prostate, often with deadly effect. Prostate cancers that have not lost that gene also can spread, or metastasize — in mice, at least — but only if they have a ready source of fat from the diet.”

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Proscavax Reduces Prostate Cancer Disease Progression

Excerpt:

“Phase 1a study results showed ProscaVax increased PSA doubling time and increased immunity to PSA, according to a manufacturer-issued press release.

“ProscaVax (OncBioMune Pharmaceuticals) is a novel immunotherapeutic cancer vaccine consisting of a combination of PSA and interleukin-2 and granulocyte-macrophage colony stimulating factor.”

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Apalutamide Granted FDA’s Priority Review for Nonmetastatic CRPC

Excerpt:

“Based on data from the phase III SPARTAN trial (ARN-509-003), apalutamide (ARN-509) has been granted a priority review by the FDA for the treatment of patients with nonmetastatic castration-resistant prostate cancer (CRPC), according to Janssen Biotech, the manufacturer of the next-generation oral androgen receptor inhibitor.

“The trial evaluated the safety and efficacy of apalutamide versus placebo in patients with a rapidly rising prostate specific antigen (PSA) level despite receiving continuous androgen deprivation therapy (ADT). The primary endpoint of the study is metastasis-free survival.”

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