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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...

lymphoma
skin cancer

Reciprocal Risks of Lymphoid Neoplasms and Cutaneous Melanoma

In a study reported in the Journal of the National Cancer Institute, Herr et al found that patients with specific types of primary lymphoid neoplasms were at increased risk of second primary cutaneous melanoma, with the reciprocal association also being observed. Occurrence of second primary...

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 ...

Use of Indwelling Pleural Catheter for Outpatient Talc Administration in Treatment of Malignant Pleural Effusion

In a UK study reported in The New England Journal of Medicine, Bhatnagar et al found that outpatient talc vs placebo administration via indwelling pleural catheter was associated with a higher rate of pleurodesis in patients with malignant pleural effusion. Study Details In the study, a target of ...

Crizotinib in East Asian Patients With ROS1-Positive Advanced NSCLC

In a phase II study reported in the Journal of Clinical Oncology, Wu et al found that crizotinib (Xalkori) was highly active in East Asian patients with ROS1-positive advanced non­–small cell lung cancer (NSCLC). Study Details In the study, 127 patients from 37 sites in China, Japan,...

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...

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: Pilot Study of Neoadjuvant Nivolumab in Resectable NSCLC

In a pilot study reported at the 2018 American Association for Cancer Research (AACR) Annual Meeting (Abstract CT079) and in The New England Journal of Medicine by Forde et al, neoadjuvant nivolumab therapy was found to be feasible and active in patients with resectable non–small cell lung...

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...

AACR 2018: Adjuvant Pembrolizumab in High-Risk Stage III Melanoma

As reported at the 2018 American Association for Cancer Research (AACR) Annual Meeting (Abstract CT001) and in The New England Journal of Medicine by Eggermont et al, the phase III EORTC 1325/KEYNOTE 054 trial has shown that adjuvant pembrolizumab (Keytruda) significantly prolonged recurrence-free...

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 ...

AACR 2018: KEYNOTE-189: Addition of Pembrolizumab to Chemotherapy in Metastatic NSCLC

As reported at the American Association for Cancer Research (AACR) Meeting (Abstract CT075) in the The New England Journal of Medicine by Gandhi et al, the first interim analysis of the phase III KEYNOTE-189 trial has shown significant improvement in overall and progression-free survival with the...

AACR 2018: CheckMate 227: Nivolumab/Ipilimumab vs Chemotherapy in NSCLC With High Tumor Mutational Burden Analysis

As reported at the 2018 American Association for Cancer Research (AACR) Meeting (Abstract CT077) and in The New England Journal of Medicine by Hellmann et al, an analysis from the phase III CheckMate 227 trial has shown that the combination of nivolumab (Opdivo) plus ipilimumab (Yervoy)...

Health-Related Quality-of Life-Analysis of Anti–PD-1 Therapy vs Chemotherapy in Advanced Urothelial Cancer

As reported by Vaughn et al in the Journal of Clinical Oncology, a health-related quality-of-life analysis from the phase III KEYNOTE-045 trial in previously treated advanced urothelial cancer showed that patients treated with the anti–programmed cell death protein 1 immunotherapy...

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...

Low-Dose Abiraterone With Food vs Standard-Dose Abiraterone in Castration-Resistant Prostate Cancer

In a phase II trial reported in the Journal of Clinical Oncology, Szmulewitz et al found that low-dose abiraterone (Zytiga) given with a low-fat meal was noninferior to standard-dose abiraterone in the fasting state with regard to reduction in prostate-specific antigen (PSA) levels among patients...

Tivantinib in Second-Line Treatment of MET-High Advanced Hepatocellular Carcinoma

In the phase III METIV-HCC trial reported in The Lancet Oncology, Rimassa et al found no improvement in overall survival with the investigational MET inhibitor tivantinib vs placebo in patients with advanced hepatocellular carcinoma with high MET expression previously treated with sorafenib...

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...

Racial/Ethnic Disparities in Liver Cancer Incidence in California

In a study among California residents reported in the Journal of the National Cancer Institute, Pham et al found that those designated as Asian/Pacific Islanders were at elevated risk of hepatocellular carcinoma (HCC) vs other racial/ethnic groups, with the highest risk observed among Southeast...

Minimal Residual Disease and Risk Stratification in Acute Myeloid Leukemia

In an analysis of the UK National Cancer Research Institute AML17 trial reported in the Journal of Clinical Oncology, Freeman et al found that detection of measureable/minimal residual disease (MRD) after first induction in acute myeloid leukemia (AML) may be prognostically equivalent to partial...

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...

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