FDA Takes Action against 14 Companies for Selling Illegal Cancer Treatments

Excerpt:

“The U.S. Food and Drug Administration today posted warning letters addressed to 14 U.S.-based companies illegally selling more than 65 products that fraudulently claim to prevent, diagnose, treat or cure cancer. The products are marketed and sold without FDA approval, most commonly on websites and social media platforms.

” ‘Consumers should not use these or similar unproven products because they may be unsafe and could prevent a person from seeking an appropriate and potentially life-saving cancer diagnosis or treatment,’ said Douglas W. Stearn, director of the Office of Enforcement and Import Operations in the FDA’s Office of Regulatory Affairs. ‘We encourage people to remain vigilant whether online or in a store, and avoid purchasing products marketed to treat cancer without any proof they will work. Patients should consult a health care professional about proper prevention, diagnosis and treatment of cancer.’ ”

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Which Patients Will Be Helped By Immune Cancer Drugs? This Test May Tell

Excerpt:

“You’ve probably heard about powerful new cancer medicines like Keytruda and Opdivo. As advertised on TV, these drugs release brakes on the immune system to make tumors disappear and extend survival in deadly diseases like lung cancer and melanoma. But these agents, called checkpoint inhibitors, work in only a fraction of patients. Scientists are searching for diagnostic tests to predict who will be helped, and who won’t.

“A promising solution comes from Foundation Medicine, a molecular diagnostics company headquartered in Cambridge, Mass. Foundation offers a cancer genome profiling test that evaluates mutations in DNA. With results from its standard FoundationOne panel, Foundation calculates a Tumor Mutation Burden (TMB) score. This quantitative readout―based on the number and type of DNA changes per megabase, a length of DNA―may prove helpful to patients considering immune treatment for many advanced forms of cancer.”

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Multi-Parametric MRI Could Avoid Second Prostate Biopsies in Some Men

Excerpt:

“The use of multi-parametric magnetic resonance imaging (mpMRI) could help avoid a repeat prostate biopsy in some men, according to a new study. The imaging test has a high sensitivity for clinically significant cancers, but could miss some and overdiagnose insignificant cancers as well.

” ‘The prostate cancer diagnostic pathway is very different to that of almost all other solid organ cancers, in that it is calibrated to detect subclinical disease but often misses clinically important disease,’ wrote study authors led by Lucy A. M. Simmons, MBBS, MRCS, of University College London. That imprecision arises from the use of transrectal ultrasound-guided (TRUS) biopsy, which is considered standard in men with elevated prostate-specific antigen (PSA) levels.”

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Discuss Prostate Screening With Your Doctor, Experts Now Say

Excerpt:

“Older men should talk to their doctors about the pros and cons of prostate cancer screening and make an individual decision that is right for them, an influential national panel of experts has proposed.

“The new recommendation, based on new data from a European trial as well as changes in the way men with prostate cancer are treated, modifies an earlier panel guideline from 2012 that advised men to skip prostate cancer screenings altogether. Screening is typically done using a blood test that measures levels of a protein released by the prostate gland called prostate-specific antigen, or PSA, which may indicate the presence of prostate cancer when elevated. But increased levels can also be caused by less serious medical conditions, like inflammation.”

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Metformin Use Does Not Increase Prostate Cancer Survival

Excerpt:

“Metformin use in combination with docetaxel chemotherapy does not significantly improve survival in patients with diabetes and metastatic castration-resistant prostate cancer, according to a study published in the April issue of The Journal of Urology.

“Michelle J. Mayer, from Sunnybrook Health Sciences Centre in Toronto, and colleagues used data from several Ontario administrative health care databases to identify men (older than 65 years) diagnosed with metastatic castration-resistant cancer and treated with docetaxel. Patients were stratified into groups based on diabetes status and use of antidiabetic medications to assess the effect of use with docetaxel on survival.”

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Higano Discusses the Potential for PARP Inhibitors in Prostate Cancer Treatment

Excerpt:

“The field of prostate cancer is rapidly progressing on several different fronts, says Celestia Higano, MD, who discussed several of the the latest advances at the 2017 Interdisciplinary Prostate Cancer Congress (IPCC).

” ‘I want the community to have a sense of the very rapid change of pace of prostate cancer therapy. I hope to spread the message of what is changing, why is it is changing, what has been shown in evidence-based therapies, and what is still experimental,’ said Higano, MD, professor of medicine and urology at the University of Washington, and a member of the Clinical Research Division at Fred Hutchinson Cancer Research Center.”

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Oncotype DX® Predicts 10-year Risk of Developing Metastatic Prostate Cancer in Low- and Intermediate-risk Patients

Excerpt:

“Genomic Health, Inc. (Nasdaq: GHDX) today announced the presentation of new results from a large multi-center validation study, which confirmed that the Oncotype DX® Genomic Prostate Score™ (GPS) is a strong independent predictor of metastases at 10 years in prostate cancer patients across all National Comprehensive Cancer Network (NCCN) clinical risk groups. The clinical validation study data were designated one of the ‘best posters’ (abstract #352) at the 32nd Annual European Association of Urology (EAU) Congress in London.”

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Study Provides Path for New Immunotherapy Approaches to Prostate Cancer

Excerpt:

“Prostate cancer, notoriously resistant to immunotherapy due to its immunologically cool nature, triggers two pathways to chill an immune attack after one immunotherapy drug fires up the immune system, researchers at The University of Texas MD Anderson Cancer Center report in Nature Medicine.

“Based on their findings, the researchers launched a clinical trial for stage IV in March combining two drugs that target separate brakes on the immune system. The checkpoint inhibitors largely failed individually against the disease. Their results also implicate for the first time on a human tumor a third brake called VISTA in potentially inhibiting .”

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Expert Discusses State of Immunotherapy in Prostate Cancer

Excerpt:

“Advancements in immunotherapy in the field of prostate cancer have been slow ever since the FDA approval of sipuleucel-T (Provenge) several years ago.

” ‘It’s an exceptionally challenging area. After the success of sipuleucel-T, there have been combinatorial approaches using radiopharmaceuticals, such as radium-223, the checkpoint inhibitor ipilimumab (Yervoy), as well as some chemotherapy regimens,’ says Susan F. Slovin, MD, PhD.

“In an interview with OncLive at the 2017 Interdisciplinary Prostate Cancer Congress, Slovin, a medical oncologist at Memorial Sloan Kettering Cancer Center, offered her expert insight on the current state of immunotherapy in prostate cancer.”

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