“The FDA authorized marketing the direct-to-consumer Personal Genome Service Genetic Health Risk Report for three mutations of BRCA1 and BRCA2 most common among people of Eastern European Ashkenazi Jewish descent, according to a press release.
“The test — marketed by 23andMe — analyzes DNA using self-collected saliva samples to determine whether a woman is at increased risk for breast and ovarian cancer and whether a man is at increased risk for breast or prostate cancer.”
“Inviting men with no symptoms to a one-off PSA test for prostate cancer does not save lives according to results from the largest ever prostate cancer trial conducted over 10 years by Cancer Research UK-funded scientists and published today (Tuesday) in the Journal of the American Medical Association (JAMA).
“Researchers at the Universities of Bristol and Oxford found that testing asymptomatic men with PSA detects some disease that would be unlikely to cause any harm but also misses some aggressive and lethal prostate cancers.”
“The federal government is threatening to limit treatment options for doctors fighting cancer. A regulatory decision due Wednesday from the Centers for Medicare and Medicaid Services could undermine the care delivered to the more than 1.6 million Americans who are diagnosed with cancer each year.”
“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.”
“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.”
“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.”
“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.”
“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.”
“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).”