FDA Grants Ceritinib Priority Review in Frontline ALK+ NSCLC

Excerpt:

“The FDA has granted a priority review to ceritinib (Zykadia) as a first-line treatment for patients with ALK-positive, metastatic non–small cell lung cancer (NSCLC), according to Novartis, the manufacturer of the second-generation ALK inhibitor.

“The priority review is based on findings from the phase III ASCEND-4 trial, in which ceritinib reduced the risk of disease progression or death by 45% compared with standard chemotherapy. The median progression-free survival (PFS) benefit favoring ceritinib was 8.5 months (HR, 0.55; 95% CI, 0.42-0.73; P <.001).”

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Expert Calls for Shorter Radiation Use in Prostate Cancer Treatment

Excerpt:

“Men with prostate cancer can receive shorter courses of radiation therapy than what is currently considered standard, according to Justin Bekelman, MD, an associate professor of Radiation Oncology, Medical Ethics, and Health Policy at the University of Pennsylvania’s Perelman School of Medicine and Abramson Cancer Center. In his call for practice change, Bekelman cites research showing the shorter radiation treatment — known as moderate hypofractionation — is just as effective at treating cancer, while costing less and easing the burden on patients. The commentary was published online by the International Journal of Radiation Oncology Biology and Physics and was co-authored by W. Robert Lee, MD, MEd, MS, a professor of Radiation Oncology at the Duke University School of Medicine.”

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Lynparza Meets Primary Endpoint in Phase III Trial in BRCA-Mutated Metastatic Breast Cancer

Excerpt:

“AstraZeneca today announced positive results from its Phase III OLYMPIAD trial comparing Lynparza (olaparib) tablets (300mg twice daily) to physician’s choice of a standard of care chemotherapy in the treatment of patients with HER2-negative metastatic breast cancer harbouring germline BRCA1 or BRCA2 mutations. Patients treated with Lynparza showed a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) compared with those who received chemotherapy (capecitabine, vinorelbine or eribulin).”

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Phase III Results Support Novel Focal Therapy for Low-Risk Prostate Cancer

Excerpt:

“Padeliporfin vascular-targeted photodynamic therapy, a novel tissue-preserving treatment, may offer men with low-risk prostate cancer a safe and effective alternative to either active surveillance or radical therapy, according to the results of a phase III trial published in The Lancet Oncology.

“Among treatment-naïve patients with low-risk, localized prostate cancer, disease progression at 24 months was 28% among patients receiving padeliporfin vascular-targeted photodynamic therapy versus 58% in those receiving active surveillance (HR, 0.34; 95% CI, 0.24-0.46; P <.0001). The median time to progression was 28.3 months (95% CI, 26.0-30.6) versus 14.1 months (95% CI, 12.9-23.8; P <.0001), respectively.”

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Four New Studies of Oncotype DX® Genomic Prostate Score™ (GPS) Reconfirm Value of Test in Guiding Early-stage Prostate Cancer Risk Assessment and Treatment Selection

Excerpt:

“Genomic Health, Inc. (GHDX) announced today the presentation of results from four studies evaluating the clinical value and utility of its Oncotype DX® Genomic Prostate Score (GPS) in the management of early-stage prostate cancer. Collectively, these new data highlight the test’s ability to predict disease aggressiveness and refine risk stratification across National Comprehensive Cancer Network (NCCN) clinical risk groups.

” ‘We now have 22 clinical studies, involving more than 4,200 prostate cancer patients, that distinguish Oncotype DX as the only test developed specifically for men who are deciding between active surveillance or definitive treatment. The test is validated to provide individualized information about both the current state and future risk of patients’ prostate cancer,’ said Phil Febbo, M.D., chief medical officer, Genomic Health. ‘Together with the recently published economic analysis demonstrating substantial cost savings of more than $2,200 per patient tested, the data presented will support increased adoption and reimbursement of Oncotype DX as physicians aim to bring precision medicine to their prostate cancer patients.’ “

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More Patients with Early-Stage Breast Cancer May Be Able to Avoid Chemotherapy in the Future

Excerpt:

“Women with early-stage breast cancer who had an intermediate risk recurrence score (RS) from a 21-gene expression assay had similar outcomes, regardless of whether they received chemotherapy, a new study from The University of Texas MD Anderson Cancer finds.

“The encouraging research, published in the journal CANCER, still needs to be validated in an ongoing international trial. If verified, women with intermediate scores may one day be able to avoid chemotherapy as standard of care.”

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Genome Analysis Helps Keep Deadly Brain Cancer at Bay for Five Years

Excerpt:

“An analysis of a patient’s deadly brain tumor helped doctors at Smilow Cancer Hospital identify new emerging mutations and keep a 55-year old woman alive for more than five years, researchers report in the journal Genome Medicine.

“The median survival rate for patients with glioblastoma multiform (GBM) is only 15 months, but three separate genomic analyses of the tumor identified new mutations that allowed doctors to adjust treatment and keep the patient alive for over five years, through two recurrences of the cancer.”

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Strosberg Discusses Latest Lutathera Data in Midgut Neuroendocrine Tumors

Excerpt:

“In December 2016, the FDA informed Advanced Accelerator Applications that its new drug application for Lutathera (177Lutetium DOTA-octreotate) as a treatment for patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs) would need to be resubmitted.

“The application was based on the phase III NETTER-1 trial, which randomized patients with advanced, progressive, somatostatin receptor-positive midgut NETS to receive either Lutathera (116 patients) plus best supportive care, including octreotide long-acting repeatable (LAR), or octreotide LAR alone (113 patients).”

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Immunotherapy Needs a New Math

Excerpt:

“A group of doctors and other healthcare industry professionals have set out to develop a more efficient tool for assessing the true value of immuno-oncology (I/O) drugs. They note that these drugs often come with high prices that may distract from their advantages over other types of therapy. For example, Kroger Pharmacy is selling the checkpoint inhibitor ipilimumab (Yervoy) for $140 per mg. At the recommended dose of 3 mg/kg for melanoma patients, the total expense can be high. However, ipilimumab is one of the class of I/O drugs that have improved expectations on supportive care costs and survival benefit. The old measures of value may not apply. Therefore, how does one determine whether $140/mg is a fair price for the drug?”

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