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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Recommendations for Genetic Counseling, Genetic Testing for Hereditary Prostate Cancer

Excerpt:

“To date, there have been few recommendations to guide physicians about when to offer men genetic consultation for prostate cancer risk. Now, an international and inter-specialty panel of experts convened at the Sidney Kimmel Cancer Center (SKCC) at Thomas Jefferson University have developed a comprehensive set of recommendations. This consensus statement, published December 13th in the Journal of Clinical Oncology, will help physicians and stakeholders make sense of a rapidly evolving field of practice.”

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Immunotherapy Continues Growth With Trials in mCRPC

Excerpt:

“Although modern immunotherapy has yet to have a breakthrough in prostate cancer to the degree it has had in lung cancer or urothelial carcinoma, combinations with anti–PD-1/PD-L1 agents are beginning to show promise for these patients in clinical trials.

“Currently ongoing is a phase II trial of durvalumab (Imfinzi) in combination with the PARP inhibitor olaparib (Lynparza) in patients with metastatic castration-resistant prostate cancer (mCRPC; NCT02484404). Investigators note that previous data have suggested that 25% to 30% of sporadic mCRPC has DNA-repair pathway defects. Results thus far have demonstrated that the synergy of durvalumab and olaparib proves that the combination may be a viable option for patients with mCRPC who are heavily pretreated. The trial is still accruing.”

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Cancer Clinical Trials Exclude Many Desperate Patients. Should That Change?

Excerpt:

“When 29-year-old Carly Bastiansen was diagnosed in January 2016 with advanced pancreatic cancer, doctors told her a clinical trial was her best shot at slowing the notoriously quick-killing and hard-to-treat disease. She found one that appeared promising and went through the screening process. But the trial would not accept her.

“ ‘Participating in a clinical trial is really my only chance at living longer,’ Bastiansen, a children’s librarian in Baltimore, said this fall as she was growing weaker. ‘To have had that option taken off the table was devastating.’ ”

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100% of Prostate Cancer Patients Completing 31-Week Post-Therapy Exam After Treatment with OncBioMune Immunotherapy Show No Disease Progression

Excerpt:

“OncBioMune Pharmaceuticals, Inc. (OTCQB:OBMP) (“OncBioMune” or the “Company”), a revenue-stage biopharmaceutical company engaged in the development of a proprietary immunotherapy cancer vaccine technology, targeted cancer therapies and commercialization of a portfolio of products internationally, is pleased to provide the latest data from the Company’s successfully completed Phase 1 trial of ProscaVax for prostate cancer, suggesting a durable response 31 weeks post-therapy.

“In the Phase 1 clinical trial, hormone-naïve and hormone-independent recurrent prostate cancer patients with increasing prostate specific antigen (PSA) were treated with six intradermal injections of ProscaVax. ProscaVax is OncBioMune’s novel immunotherapeutic cancer vaccine consisting of a combination of prostate cancer associated PSA with the biological adjuvants interleukin-2 (IL-2) and granulocyte-macrophage colony-stimulating factor (GM-CSF).”

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Shorter Course of Treatment May Provide Better Outcome for Intermediate-Risk Prostate Cancer

Excerpt:

“Prostate cancer is the most common cancer among males in the United States. Approximately, 180,000 men are diagnosed each year, and approximately 95 percent of these men have localized disease that is potentially curable. Previously, studies have consistently demonstrated that conventionally fractionated high dose external beam radiation therapy (CRT), consisting of daily treatment for two months, decreases prostate cancer recurrence, and improves metastasis-free survival. Previous studies also demonstrate that moderate hypo-fractionated radiation therapy (HRT), consisting of daily treatment for one month using a larger dose per treatment, provides a similar low risk of recurrence, and may even be lower with HRT than CRT.”

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PET Identifies Which Prostate Cancer Patients Can Benefit from Salvage Radiation Treatment

Excerpt:

“For prostate cancer patients who have rising levels of PSA (a cancer indicator) even after radical prostatectomy, early treatment makes a difference. In a study featured in the December issue of The Journal of Nuclear Medicine, Australian researchers demonstrate that PET scans can identify which of these prostate cancer patients would benefit from salvage radiation treatment (SRT).

” ‘The research is novel because it looks at the impact of PSMA PET/CT on patient responses to , not just on whether the PET scan results in changed management,’ explains Louise Emmett, MD, of the St. Vincent’s Hospital, Sydney, Australia. She elaborates, ‘In the study, these patients underwent imaging with a PSMA PET scan and had treatment based on the results of the scan findings. The study then followed how these men were treated, and whether the treatment was effective.’ ”

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FDA Approves First-of-a-Kind Test for Cancer-Gene Profiling

Excerpt:

“U.S. regulators have approved a first-of-a-kind test that looks for mutations in hundreds of cancer genes at once, giving a more complete picture of what’s driving a patient’s tumor and aiding efforts to match treatments to those flaws.

“The U.S. Food and Drug Administration approved Foundation Medicine’s test for patients with advanced or widely spread cancers, and the Centers for Medicare and Medicaid Services proposed covering it.

“The dual decisions, announced late Thursday, will make tumor-gene profiling available to far more cancer patients than the few who get it now and will lead more insurers to cover it.”

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FDA Aims to Expand Early-Approval Program for Promising Drugs

Excerpt:

“The Food and Drug Administration wants to help patients get faster access to promising cancer treatments.

“The agency is preparing proposals that would expand an accelerated-approval program for lifesaving medications, FDA Commissioner Scott Gottlieb told House lawmakers on Thursday.

“Drugmakers can seek rapid conditional approval for treatments for cancer or other serious diseases based on evidence that a drug is likely to extend patient survival. Later trials once such a drug is on the market are necessary to prove the survival benefit.”

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