CMS Starts to Cover Broad Cancer DNA Tests, Boosting Foundation, Thermo

Excerpt:

“The Centers for Medicare & Medicaid Services, which administers the federal Medicare insurance program, will begin covering FDA-approved diagnostic tests that scan tumors for a range of genetic mutations. The news is a boost for companies like Foundation Medicine and Thermo Fisher Scientific, who are among the few firms with such tests on the market.

“Late Friday, the CMS said that, going forward, it will start to reimburse for tests that use DNA sequencing technology to map the tumors of patients with advanced cancers once approved by the FDA. Two of the already-approved tests fitting this description are FoundationOne CDx, from Cambridge, MA-based Foundation, and Oncomine Dx Target Test, from Waltham, MA-based Thermo Fisher Scientific (NYSE: TMO). FoundationOne CDx looks for 324 cancer-related alterations in patients’ DNA. Foundation amasses a report based on the results and sends it to doctors, who use the data to suggest possible treatments. Oncomine detects 23 genetic alterations associated with non-small cell lung cancer.”

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Apalutamide, Enzalutamide Improve Metastasis-Free Survival in Nonmetastatic Castrate-Resistant Prostate Cancer

Excerpt:

In two separate trials presented at the 2018 Genitourinary Cancers Symposium, apalutamide and enzalutamide (Xtandi), respectively, reduced the risk of metastasis and prolonged metastasis-free survival in men with high-risk nonmetastatic castrate-resistant prostate cancer. In the SPARTAN trial, apalutamide reduced the risk of developing metastasis and death by 72% compared with placebo, and in the PROSPER trial, enzalutamide reduced the risk of metastasis or death by 71% compared with placebo. In both studies, men were treated with ongoing androgen-deprivation therapy.”

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Adjuvant Radiotherapy Improves Outcomes for High-Risk Prostate Cancer

Excerpt:

“Adjuvant radiotherapy appeared associated with better outcomes than surveillance followed by early-salvage radiotherapy among patients with prostate cancer with adverse pathological features who underwent prostatectomy, according to study results published in JAMA Oncology.

” ‘It remains very controversial whether patients with high-risk features after a radical prostatectomy for prostate cancer should receive adjuvant radiation therapy to prevent a recurrence of their prostate cancer as measured by a rise in PSA, or whether we should observe patients after surgery and only radiate those who demonstrate a detectable PSA,’ Rahul D. Tendulkar, MD, of the department of radiation oncology at Cleveland Clinic, told HemOnc Today.”

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FDA Authorizes Direct-To-Consumer Genetic Test for Three BRCA Mutations

Excerpt:

“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.”

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One-Off PSA Screening for Prostate Cancer Does Not Save Lives

Excerpt:

“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.”

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A New Regulatory Threat to Cancer Patients

Excerpt:

“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.”

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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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