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Cancer Cost Planning and Accounting for Patients Under 65

A new study published by Banegas et al in JNCCN–Journal of the National Comprehensive Cancer Network has found that cancer care costs in the United States are higher for people under age 65—and that costs increase with disease stage. Despite the fact that nearly half of new cancer...

CB-839 in Combination With Cabozantinib for Advanced RCC Granted FDA Fast Track Designation

On April 18, Calithera Biosciences, Inc, announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to CB-839 in combination with cabozantinib for the treatment of patients with metastatic renal cell carcinoma (RCC) who have received one or two prior lines of therapy, ...

FDA Grants Fast Track Designation for Balixafortide in Combination With Eribulin as Third-Line Therapy for Metastatic Breast Cancer

On April 19, Polyphor announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for its novel immuno-oncology candidate balixafortide (POL6326) in combination with eribulin (Halaven) for the treatment of patients with HER2-negative metastatic breast cancer who...

issues in oncology

Barbara McAneny, MD, on The Business of Cancer

Barbara McAneny, MD, Co-Founder and CEO, New Mexico Oncology Hematology Consultants; President-Elect, American Medical Association, speaks during Panel 2: The Business of Cancer at The Policy, Politics and Law of Cancer, presented by The Solomon Center for Health Law and Policy at Yale Law School,...

Follicular Extension in Actinic Keratosis and Invasion in Squamous Cell Carcinoma

Actinic keratoses may show extension down into follicles, not only in cases with full-thickness epidermal atypia (bowenoid actinic keratosis), but also in cases with atypia limited to the epidermal basalis. Previous studies have demonstrated that, in bowenoid actinic keratosis, follicular...

health-care policy
issues in oncology

COA Practice Impact Report Details Consolidation, Shift of U.S. Cancer Care System Into More Expensive Hospital Setting

The Community Oncology Alliance (COA) has released the 2018 Community Oncology Practice Impact Report, which tracks data on the changing landscape of cancer care in the United States. It details a decade-long trend of closure and consolidation in the U.S. cancer system that has resulted in a...

Personalized Tumor Vaccine Shows Promise in Advanced Ovarian Cancer

A new type of cancer vaccine has yielded promising results in an initial clinical trial conducted at the Perelman School of Medicine at the University of Pennsylvania and the Abramson Cancer Center of the University of Pennsylvania. The personalized vaccine is made from a patient’s own immune ...

St. Jude Cloud, Largest Public Repository of Pediatric Cancer Genomics Data, Launches for Researchers Worldwide

On April 12, St. Jude Children’s Research Hospital launched the St. Jude Cloud, an online data-sharing and collaboration platform that provides researchers access to the world's largest public repository of pediatric cancer genomics data. Developed as a partnership among St. Jude,...

FDA Unveils Streamlined Path for Authorizing Tumor-Profiling Tests Alongside Its Latest Product Action

The U.S. Food and Drug Administration (FDA) recently finalized two guidances to drive the efficient development of next-generation sequencing, which scans a person’s DNA to diagnose genetic diseases, and guide medical treatments. The guidances provide recommendations for designing,...

Update on ATLAS Trial of Axitinib as Adjuvant Treatment for Patients at High Risk of Renal Cell Carcinoma Recurrence After Surgery

Pfizer recently announced that the independent data monitoring committee for the phase III ATLAS trial, which is evaluating axitinib (Inlyta) as adjuvant therapy for patients at high risk of recurrent renal cell carcinoma (RCC) after nephrectomy, recommended stopping the trial at a planned interim...

issues in oncology
survivorship

ASCO Clinical Practice Guideline Update: Fertility Preservation in Patients With Cancer

As reported in the Journal of Clinical Oncology by Kutluk Oktay, MD, PhD, of Yale University School of Medicine, and colleagues, ASCO has issued a clinical practice guideline update on fertility preservation in adults and children with cancer. The update was informed by an update panel systematic...

FDA Approves Osimertinib for First-Line Treatment of Metastatic NSCLC With Most Common EGFR Mutations

On April 18, the U.S. Food and Drug Administration (FDA) approved osimertinib (Tagrisso) for the first-line treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as...

issues in oncology

Norman Sharpless, MD: Keynote Address

Norman Sharpless, MD, Director, National Cancer Institute, presents the Keynote Address at The Policy, Politics and Law of Cancer, presented by The Solomon Center for Health Law and Policy at Yale Law School, in collaboration with Smilow Cancer Hospital and Yale Cancer Center.

issues in oncology

Siddhartha Mukherjee, MD, DPhil: Keynote Address

Siddhartha Mukherjee, MD, DPhil, Assistant Professor of Medicine, Columbia University Medical Center, presents the Keynote Address at The Policy, Politics and Law of Cancer, presented by The Solomon Center for Health Law and Policy at Yale Law School, in collaboration with Smilow Cancer Hospital...

issues in oncology
health-care policy
legislation

Charles Sawyers, MD, on Legal and Policy Issues Associated With Cutting-Edge Cancer Treatments

Charles Sawyers, MD, Chair, Human Oncology and Pathogenesis Program, Memorial Sloan Kettering Cancer Center, speaks during Panel 5: Legal and Policy Issues Associated With Cutting-Edge Cancer Treatments at The Policy, Politics and Law of Cancer, presented by The Solomon Center for Health Law and...

issues in oncology
cost of care

Peter Bach, MD, MAPP, on Drug Development and the Cost of Researching and Treating Cancer

Peter Bach, MD, MAPP, Director of the Center for Health Policy and Outcomes, Memorial Sloan Kettering Cancer Center, speaks during Panel 4: Drug Development and the Cost of Researching and Treating Cancer at The Policy, Politics and Law of Cancer, presented by The Solomon Center for Health Law and...

issues in oncology
cost of care

Amy Kapczynski, JD, on Drug Development and the Cost of Researching and Treating Cancer

Amy Kapczynski, JD, Professor of Law and Faculty Director, Global Health Justice Partnership, Yale Law School, speaks during Panel 4: Drug Development and the Cost of Researching and Treating Cancer at The Policy, Politics and Law of Cancer, presented by The Solomon Center for Health Law and Policy ...

issues in oncology
cost of care

Levi Garraway, MD, PhD, on Drug Development and the Cost of Researching and Treating Cancer

Levi Garraway, MD, PhD, Senior Vice President, Global Development & Medical Affairs, Eli Lilly, speaks during Panel 4: Drug Development and the Cost of Researching and Treating Cancer at The Policy, Politics and Law of Cancer, presented by The Solomon Center for Health Law and Policy at Yale...

issues in oncology

Deborah Schrag, MD, MPH, on Cancer, Health Justice, and Disparities

Deborah Schrag, MD, MPH, Chief, Division of Population Sciences, Department of Medical Oncology, Dana-Farber Cancer Institute; Professor of Medicine, Harvard Medical School, speaks during Panel 3: Cancer, Health Justice, and Disparities at The Policy, Politics and Law of Cancer, presented by The...

issues in oncology

Blase Polite, MD, on Cancer, Health Justice, and Disparities

Blase Polite, MD, Associate Professor of Medicine, University of Chicago Medical Center, speaks during Panel 3: Cancer, Health Justice, and Disparities at The Policy, Politics and Law of Cancer, presented by The Solomon Center for Health Law and Policy at Yale Law School, in collaboration with...

issues in oncology

Otis Brawley, MD, on Cancer, Health Justice, and Disparities

Otis Brawley, MD, Chief Medical Officer, American Cancer Society, speaks during Panel 3: Cancer, Health Justice, and Disparities at The Policy, Politics and Law of Cancer, presented by The Solomon Center for Health Law and Policy at Yale Law School, in collaboration with Smilow Cancer Hospital and...

issues in oncology

Lee Newcomer, MD, MHA, on The Business of Cancer

Lee Newcomer, MD, MHA, Senior Vice President, Oncology, Genetics and Women’s Health, UnitedHealthcare, speaks during Panel 2: The Business of Cancer at The Policy, Politics and Law of Cancer, presented by The Solomon Center for Health Law and Policy at Yale Law School, in collaboration with Smilow...

issues in oncology

Randall Oyer, MD, on The Business of Cancer

Randall Oyer, MD, Medical Director, Oncology Program, Lancaster General Hospital, speaks during Panel 2: The Business of Cancer at The Policy, Politics and Law of Cancer, presented by The Solomon Center for Health Law and Policy at Yale Law School, in collaboration with Smilow Cancer Hospital and...

issues in oncology

Ed Benz, MD, on The Business of Cancer

Ed Benz, MD, President and CEO Emeritus, Dana-Farber Cancer Institute, speaks during Panel 2: The Business of Cancer at The Policy, Politics and Law of Cancer, presented by The Solomon Center for Health Law and Policy at Yale Law School, in collaboration with Smilow Cancer Hospital and Yale Cancer...

issues in oncology

Abe Lopman, MBA, on The Business of Cancer

Abe Lopman, MBA, Senior Vice President, Operations; Executive Director, Smilow Cancer Hospital at Yale New Haven, speaks during Panel 2: The Business of Cancer at The Policy, Politics and Law of Cancer, presented by The Solomon Center for Health Law and Policy at Yale Law School, in collaboration...

health-care policy

Richard Schilsky, MD: Is the Federal Government a Productive Partner in Cancer Policy?

Richard Schilsky, MD, Chief Medical Officer, ASCO, speaks during Panel 1: Is the Federal Government a Productive Partner in Cancer Policy? at The Policy, Politics and Law of Cancer, presented by The Solomon Center for Health Law and Policy at Yale Law School, in collaboration with Smilow Cancer...

Following Nutrition and Exercise Guidelines May Prolong Survival in Stage III Colon Cancer

A diet high in whole grains, fruits, and vegetables—along with exercise and maintaining a healthy body weight—can improve the 5-year survival rate for patients with stage III colorectal cancer, according to a new report published by Van Blarigan et al in JAMA Oncology. The findings...

Pembrolizumab Monotherapy in NSCLC Meets Primary Endpoint in Phase III KEYNOTE-042 Study

On April 9, the phase III KEYNOTE-042 trial evaluating pembrolizumab (Keytruda) as monotherapy for the first-line treatment of locally advanced or metastatic non–small cell lung cancer (NSCLC, including nonsquamous or squamous histologies) met its primary endpoint of overall survival (OS). An ...

health-care policy

Nancy Goodman, JD, MPP: Is the Federal Government a Productive Partner in Cancer Policy?

Nancy Goodman, JD, MPP, Executive Director, Kids V Cancer, speaks during Panel 1: Is the Federal Government a Productive Partner in Cancer Policy? at The Policy, Politics and Law of Cancer, presented by The Solomon Center for Health Law and Policy at Yale Law School, in collaboration with Smilow...

health-care policy

Nancy Goodman, JD, MPP: Is the Federal Government a Productive Partner in Cancer Policy?

Nancy Goodman, JD, MPP, Executive Director, Kids V Cancer, speaks during Panel 1: Is the Federal Government a Productive Partner in Cancer Policy? at The Policy, Politics and Law of Cancer, presented by The Solomon Center for Health Law and Policy at Yale Law School, in collaboration with Smilow...

AACR 2018: Boosting T-Cell Memory May Result in Longer-Lasting Responses in Patients Treated With Checkpoint Blockade Immunotherapies

Some T cells have excellent memories. These subtypes—known as memory T cells—may explain why some immunotherapies are more effective than others and could potentially lead to researchers designing more effective studies using combination checkpoint blockade treatments, according to...

AACR 2018: New Liquid Biopsy–Based Cancer Model Reveals Data on Chemoresistance in SCLC

Small cell lung cancer (SCLC) accounts for 14% of all lung cancers and is often rapidly resistant to chemotherapy, resulting in poor clinical outcomes. Treatment has changed little for decades, but a study at The University of Texas MD Anderson Cancer Center offers a potential explanation for...

FDA Approves Fostamatinib Disodium Hexahydrate for Chronic Immune Thrombocytopenia in Adult Patients

On April 17, the U.S. Food and Drug Administration (FDA) approved fostamatinib disodium hexahydrate (Tavalisse) for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. Fostamatinib is an oral spleen ...

Investigational in Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination

On April 16, 2018, the U.S. Food and Drug Administration (FDA) issued a draft guidance, “Investigational in Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination,” to describe for sponsors of certain oncology trials an optional streamlined...

AACR 2018: Short-Acting Calcium Channel Blockers Associated With Increased Risk of Pancreatic Cancer in Postmenopausal Women

Calcium channel blockers (CCBs)—specifically the short-acting form of CCBs, which are prescribed to treat high blood pressure—were associated with an increased risk of pancreatic cancer in postmenopausal women, according to a study presented at the American Assocation for Cancer...

AACR 2018: Dual Inhibition of IDO1 and PD-L1 Safe in Patients With Advanced Solid Tumors

Treatment combining the IDO1 inhibitor epacadostat and the programmed cell death ligand 1 (PD-L1) inhibitor durvalumab (Imfinzi) was found to be safe in patients with advanced solid tumors, with safety data similar to treatment with durvalumab alone, according to data presented from the ongoing...

AACR 2018: TLR9 Agonist CMP-001/Pembrolizumab Combination Shows Early Efficacy in Patients With Metastatic Melanoma Resistant to Anti–PD-1

A combination of CMP-001, an intratumoral Toll-like receptor 9 (TLR9) agonist, and pembrolizumab (Keytruda) was well tolerated and had clinical activity in patients with metastatic melanoma resistant to programmed cell death protein 1 (PD-1) checkpoint inhibition, according to preliminary data...

AACR 2018: Prototype Assays Suggest Highly Specific Blood Test to Screen for Cancer Is Feasible

Initial findings from the Circulating Cell-Free Genome Atlas (CCGA) study showed that prototype sequencing assays tested in this analysis may facilitate the development of a highly specific blood test for early cancer detection, according to data presented at the American Association for Cancer...

FDA Approves Nivolumab/Ipilimumab Combination in Intermediate- or Poor-Risk Advanced RCC

On April 16, 2018, the U.S. Food and Drug Administration (FDA) granted approvals to nivolumab (Opdivo) and ipilimumab (Yervoy) in combination for the treatment of intermediate- or poor-risk previously untreated advanced renal cell carcinoma (RCC). CheckMate 214 The approvals were based on...

AACR 2018: Off-the-Shelf, Dual-Targeted CAR T-Cell Product Showed Promising Results in Preclinical Studies

FT819—an off-the-shelf, T-cell receptor–less CD19 chimeric antigen receptor (CAR) T-cell product that could potentially be made more accessible to patients with cancer than conventional CAR T-cell therapies—showed positive results in preclinical specificity, functionality, and...

solid tumors
lung cancer

AACR 2018: Selective Inhibitor Shows Early Promise in Patients With RET-Altered Cancers

BLU-667, a next-generation inhibitor that selectively targets the oncogenic receptor tyrosine kinase RET, was well tolerated and had broad clinical benefit in patients with advanced cancer that had progressed on previous therapies, including multikinase inhibitor therapy. Proof-of-concept data from ...

AACR 2018: Crizotinib Yielded a High Objective Response Rate for Adult Patients With ALK-Positive Inflammatory Myofibroblastic Tumor

Among patients with inoperable, advanced, or metastatic ALK-positive inflammatory myofibroblastic tumor, 50% were confirmed to have partial or complete tumor shrinkage after treatment with the ALK-targeted anticancer therapeutic agent crizotinib (Xalkori), according to data from the phase II EORTC...

AACR 2018: Children With Nonchromosomal Birth Defects May Face Higher Risk of Several Childhood Cancers

Children with nonchromosomal birth defects—such as congenital heart disease—had a significantly higher risk of developing childhood cancer than children who did not have birth defects, according to a study presented at the 2018 American Association for Cancer Research (AACR) Annual...

Wait for Diagnostic Testing and Effect on Outcomes in Patients With Cancer

The longer patients with a positive screening result wait for diagnostic testing, the worse their cancer outcomes may become, according to a literature review of breast, cervical, colorectal, and lung studies published by Doubeni et al in CA: A Cancer Journal for Clinicians led by researchers at...

Epacadostat Combined With Pembrolizumab in Patients With Unresectable or Metastatic Melanoma

On April 6, an external data monitoring committee commented on results from the phase III ECHO-301/KEYNOTE-252 trial of the investigational IDO1 inhibitor epacadostat plus pembrolizumab (Keytruda) in patients with unresectable or metastatic melanoma. The committee determined that the study did not...

leukemia
lymphoma

FDA Accepts New Drug Application, Grants Priority Review for Duvelisib in CLL/SLL and Follicular Lymphoma

On April 9, the U.S. Food and Drug Administration (FDA) accepted for filing with Priority Review a new drug application (NDA) for the oral agent duvelisib, a first-in-class, dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma. The NDA is seeking full approval for duvelisib in...

Clinical Hold Lifted on U.S. Studies of BPX-501

On April 11, Bellicum Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on studies of BPX-501 in the U.S. The decision follows consultation with the FDA and agreement on amendments to the study protocols including guidance on monitoring...

ELCC 2018: Canadian Study Shows Coordinating Nurses Can Improve Patients’ Quality of Life and Satisfaction During Lung Cancer Treatment

Investing in the continuity of care for lung cancer patients can bring tremendous benefits in terms of patient satisfaction and quality of life. In Quebec, this investment has taken the form of a dedicated role on the medical team: The Pivot Nurse in Oncology (PNO). A study presented by Kassouf et...

ELCC 2018: Second-Line Tyrosine Kinase Inhibitor Therapy Demonstrates Clinical Benefit in EGFR-Mutated NSCLC With Leptomeningeal Metastasis

Erlotinib (Tarceva) or high-dose erlotinib provides benefit in patients with epidermal growth factor receptor (EGFR) mutated non–small cell lung cancer (NSCLC) who develop leptomeningeal metastasis during or after treatment with a tyrosine kinase inhibitor. Findings supporting second-line...

ELCC 2018: Alectinib Provides Longer Symptom Improvement Than Crizotinib in ALK-Positive Lung Cancer

Alectinib provides longer symptom improvement than crizotinib in <em>ALK</em>-positive non–small cell lung cancer (NSCLC), according to results from the ALEX trial presented by Pérol et al at the European Lung Cancer Congress (ELCC) in Geneva, Switzerland (Abstract...

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