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FDA News - July 2015
FDA Approvals, News & Updates
July 2015, Vol 6, No 6
The FDA’s Oncologic Drug Advisory Committee (ODAC) reviewed necitumumab (Eli Lilly & Co) for use in patients with metastatic squamous non–small-cell lung cancer (NSCLC). Necitumumab is an immunoglobulin G1 monoclonal antibody that inhibits the interaction between the human epidermal growth factor receptor (EGFR) and its ligands. EGFR expression is elevated in NSCLC and affects >95% of squamous NSCLC tumors.
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ASCO’s Value Framework Abandons the Hippocratic Oath
By
Robert Goldberg, PhD
ASCO’s Value Framework
,
Value-Based Care
,
VBCC Perspectives
,
Economics & Value
July 2015, Vol 6, No 6
The American Society of Clinical Oncology (ASCO) new value framework abandons the Hippocratic Oath. No longer is the doctor’s first obligation to “apply, for the benefit of the sick, all measures which are required.” Instead, ASCO’s value framework has the potential to help insurers “evaluate the relative value of new treatments” as they develop “benefit structures, adjustment of insurance premiums, and implementation of clinical pathways and administrative controls."
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ASCO Develops New Framework to Evaluate the Value of Cancer Therapies
By
Laura Morgan
ASCO’s Value Framework
July 2015, Vol 6, No 6
Cancer care is one of the fastest growing components of US healthcare costs and is estimated to reach $158 billion by 2020. The American Society of Clinical Oncology (ASCO) Value in Cancer Care Task Force attributes the rising cost of cancer care to several factors, including the overall aging of the population, the introduction of costly new drugs and innovative surgery and radiation techniques, and the adoption of more expensive diagnostic tests.
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In the Literature - June 2015
In the Literature
June 2015, Vol 6, No 5
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Risk Management a Key Challenge in the New Oncology Payment Models
By
Wayne Kuznar
June 2015, Vol 6, No 5
In a decade of provider risk, the CMS Oncology Payment Models are shifting toward risk management as part of the continued evolution toward integrated networks and bundled payments in healthcare.
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Elotuzumab, First-in-Class Monoclonal Antibody Immunotherapy, Improves Outcomes in Patients with Multiple Myeloma
By
Phoebe Starr
ASCO 2015 Highlights
,
ASCO
June 2015, Vol 6, No 5
Elotzumab’s “double whammy” mechanism of action acts directly on the tumor itself and enhances the activity of natural killer cells to kill the tumor.
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Combination Immunotherapy Superior to Monotherapy in Patients with Melanoma
By
Chase Doyle
ASCO 2015 Highlights
,
ASCO
June 2015, Vol 6, No 5
Combination treatment with nivolumab and ipilimumab doubled progression-free survival in patients with advanced melanoma, according to CheckMate 067 investigators.
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Expert Panel Discusses Quality Measures, Data Collection, and Outcomes in Oncology
By
Wayne Kuznar
June 2015, Vol 6, No 5
Experts at the AVBCC 5th Annual Conference suggested that retrospective analyses of big data should more effectively differentiate between different approaches to cancer care based on care quality and evidence-based, clinically meaningful outcomes. Data silos can help in the short-term to prioritize process measures.
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Jakafi (Ruxolitinib): First FDA-Approved Medication for the Treatment of Patients with Polycythemia Vera
By
Lisa A. Raedler, PhD, RPh
Drug Updates
June 2015, Vol 6, No 5
Similar to myelofibrosis and essential thrombocythemia, polycythemia vera is a Philadelphia chromosome–negative myeloproliferative neoplasm. Polycythemia vera is characterized by the clonal stem-cell proliferation of red blood cells, white blood cells, and platelets. Increased red blood cell mass results in the hyperviscosity of the blood, an increased risk for thrombosis, poor quality of life, and a shortened life expectancy.
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Less Is More in Cancer Survivor Care
By
Rosemary Frei, MSc
Survivorship
,
Policies & Guidelines
June 2015, Vol 6, No 5
Two oncologists from Fox Chase Cancer Center in Philadelphia have added their weight to the growing call for less intensive follow-up of cancer survivors whenever appropriate.
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Home
Issues
Online First
Latest Issue
Issue Archive
Special Issues
Browse By Topic
Personalized Medicine
Economics & Value
FDA Approvals, News & Updates
COVID-19
Cholangiocarcinoma
View All Topics ›
Conference Correspondent
ESMO 2025 - Wrap-Up: Triple-Negative Breast Cancer
ASCO 2025 - Wrap-Up: Triple-Negative Breast Cancer
Web Exclusives
Web Exclusive Articles
Videos
Interview with the Innovators
Prostate Cancer Diagnostics Monthly Minutes
Webinars
Quick Quiz
Press Releases
Association for Value-Based Cancer Care
VBCM
Value-Based Care in Myeloma