Apalutamide Submitted for FDA Approval in Prostate Cancer

Excerpt:

“Janssen Biotech has submitted a new drug application to the FDA for apalutamide (ARN-509) for the treatment of non-metastatic castration-resistant prostate cancer (CRPC), the manufacturer of the next-generation oral androgen receptor inhibitor announced today.

“Apalutamide inhibits the action of testosterone in prostate cancer cells and prevents androgen from binding to the androgen receptor. Currently, there are no FDA-approved treatments for patients with nonmetastatic CRPC, Janssen noted in a press release.”

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Researchers Reveal Biomarker for Guiding Prostate Cancer Treatment

Excerpt:

“Back-to-back discoveries from Cleveland Clinic demonstrate for the first time how a testosterone-related genetic abnormality can help predict individual patient responses to specific prostate cancer therapies.

“The studies, published in the October 12 issue of JAMA Oncology, suggest that men who inherit this  would benefit from a personalized treatment plan that targets specific hormonal pathways.”

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New Targeted Alpha Therapy Protocol for Advanced Prostate Cancer

Excerpt:

“Therapy options are limited for men with advanced-stage, metastatic castration-resistant prostate cancer (mCRPC), but a new treatment protocol offers hope. In the featured article of The Journal of Nuclear Medicine‘s October issue, German researchers report on their recent clinical experience, which establishes a dosing regimen for actinium-225 (225Ac)-labeled targeted alpha therapy of patients with prostate specific membrane antigen (PSMA)-positive tumors. The protocol balances treatment response with toxicity concerns to provide the most effective therapy with the least side effects.”

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PSMA-PET Agents Poised to Advance Imaging in Prostate Cancer

Excerpt:

“Imaging agents for the detection of biochemical recurrent prostate cancer could move beyond computed tomography (CT) and magnetic resonance imaging (MRI) in the near future, with the emergence of prostate-specific membrane antigen (PSMA)-PET, particularly in oligometastatic disease, with a high-detection sensitivity rate, explains Thomas Hope, MD.

“PSMA-PET uses small molecules that bind to PSMA, localizes a prostate cancer tumor, and allows radiologists to image patients after 1 hour to detect small sites of disease. Hope and researchers at the University of California, San Francisco (UCSF) are dedicated to bringing this imaging modality to the FDA for approval with diagnostic data as evidence.”

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Pivotal Role Remains With Bone-Targeting Agents in mCRPC

Excerpt:

“Prostate cancer researchers are continuing to explore strategies to optimally integrate bone-targeted agents into patient care.

“For example, an ongoing trial is assessing the combination of a radiopharmaceutical, radium-223 dichloride (Xofigo), with an androgen receptor-directed therapy, either abiraterone acetate (Zytiga) or enzalutamide (Xtandi). The open-label, phase IIa study is accruing patients with metastatic castration-resistant prostate cancer (mCRPC). The primary endpoint of the trial, which hopes to enroll 68 patients, is patient bone scan response rate (NCT02034552).”

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ESMO 2017 Press Release: Patients with High Risk Prostate Cancer May Benefit “Equally” From Two New Treatments

Excerpt:

“Patients with high risk prostate cancer starting long-term hormone therapy may benefit from two new treatments, according to late-breaking results from the STAMPEDE trial presented at the ESMO 2017 Congress in Madrid.

“Long-term hormone therapy alone has been the standard of care for patients with high risk locally advanced or metastatic prostate cancer since the 1940s.”

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A New Study Claims Prostate Cancer Screenings Significantly Reduce Deaths. Not Everyone Agrees

Excerpt:

“An analysis of two influential studies of prostate cancer screening concludes that the much-debated test “significantly” reduces deaths from the disease, suggesting that current recommendations against routine PSA screening might be steering men away from a lifesaving procedure.

“The analysis, published Monday in Annals of Internal Medicine, drew wildly different reactions, as is often the case with research on PSA screenings. Some experts in cancer screening and statistics said its novel approach was “on shaky ground” and used a “completely unverifiable” methodology that they had “never seen before,” but others praised its “intriguing and innovative approach.” There was one area of agreement, however: “I imagine it’s going to generate some buzz,” said biostatistician Ted Karrison of the University of Chicago.”

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A Cancer Doctor Weighs In On CAR-T, Precision Medicine And Pricing Debates

Excerpt:

“Yesterday’s historic FDA approval of the first engineered T-cell treatment for cancer, Novartis’ Kymriah (tisagenlecleucel), was accompanied by inevitable questions about how the product would be priced. In the end, Novartis set the price at $475,000, which was lower than many analysts had predicted, considering the treatment is designed to cure some forms of acute lymphoblastic leukemia (ALL)—and in clinical trials it did just that for most patients.”

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A Cancer Conundrum: Too Many Drug Trials, Too Few Patients

Excerpt:

“With the arrival of two revolutionary treatment strategies, immunotherapy and personalized medicine, cancer researchers have found new hope — and a problem that is perhaps unprecedented in medical research.

“There are too many experimental cancer drugs in too many clinical trials, and not enough patients to test them on.

“The logjam is caused partly by companies hoping to rush profitable new cancer drugs to market, and partly by the nature of these therapies, which can be spectacularly effective but only in select patients.”

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