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FDA Expands Tisagenlecleucel Approval to Include Relapsed or Refractory Large B-Cell Lymphoma

On May 1, the U.S. Food and Drug Administration (FDA) approved tisagenlecleucel (Kymriah) suspension for intravenous infusion for the treatment of adult patients with relapsed or refractory large B-cell lymphoma—including diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, and...

New Breath and Urine Tests May Detect Early Breast Cancer More Accurately

A new method for early, more accurate breast cancer screening has been developed by researchers at Ben-Gurion University of the Negev and Soroka University Medical Center using commercially available technology. Their findings were published by Herman-Saffar et al in Computers in Biology and...

MGUS and Multiple Myeloma in 9/11 Firefighters

A study by Landgren et al in JAMA Oncology has found that New York City firefighters exposed to the 9/11 World Trade Center (WTC) disaster site face an increased risk for developing monoclonal gammopathy of undetermined significance (MGUS), a myeloma precursor disease. The study was conducted...

Positive Results From QUADRA Trial of Niraparib in Ovarian Cancer

Tesaro recently announced results from the QUADRA study, which was designed to assess the clinical benefit of niraparib (Zejula) treatment in heavily pretreated patients with ovarian cancer. Results successfully achieved the prespecified primary endpoint and demonstrated niraparib monotherapy...

Results From the ARCTIC Trial in Third-Line Treatment of NSCLC

AstraZeneca and MedImmune have announced high-level results from the phase III ARCTIC trial in patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) who have received at least two prior treatments. This randomized, open-label, multicenter trial assessed the efficacy...

FDA Approves Dabrafenib Plus Trametinib for Adjuvant Treatment of Melanoma With BRAF V600E or V600K Mutations

On April 30, 2018, the U.S. Food and Drug Administration (FDA) granted regular approval to dabrafenib (Tafinlar) and trametinib (Mekinist) in combination for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations (as detected by an FDA-approved test) and involvement of...

solid tumors
hematologic malignancies

Update Regarding Tazemetostat Clinical Program

On April 23, Epizyme, Inc, announced that U.S.-based enrollment of new patients into tazemetostat clinical trials is temporarily on hold. Following a safety report of a pediatric patient who developed a secondary lymphoma, the U.S. Food and Drug Administration (FDA) issued a partial clinical hold...

Results From Phase III RANGE Study of Ramucirumab in Advanced or Metastatic Urothelial Cancer

Eli Lilly and Company recently announced additional results from its global, randomized, double-blind, placebo-controlled phase III RANGE trial evaluating ramucirumab (Cyramza) in combination with docetaxel in patients with locally advanced or unresectable or metastatic urothelial carcinoma whose...

Many Economic Evaluations of Oncotype DX May Have Misleading Conclusions

Research from the Yale School of Public Health has found that the majority of published papers analyzing the cost-effectiveness of a widely used test for breast cancer used a study design that can increase bias. These findings were published by Wang et al in the Journal of Clinical Oncology....

legislation
health-care policy

Roy Herbst, MD, PhD, on Legal and Policy Issues Associated With Cutting-Edge Cancer Treatments

Roy Herbst, MD, PhD, Chief of Medical Oncology, Yale Cancer Center and Smilow Cancer Hospital, 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 Policy at Yale...

Hematology Fellows and Junior Faculty Participate in 2018 ASH Clinical Research Training Institute in Latin America

This week, the American Society of Hematology (ASH) announced the names of the 35 hematologists participating in the 2018 ASH Clinical Research Training Institute in Latin America (CRTI-LA) and Advanced CRTI-LA. This education and mentorship program was held April 23–26, prior to the...

lung cancer
gastroesophageal cancer

ESTRO 37: Positioning for Radiotherapy and Impact on Survival in Patients With Lung or Esophageal Cancers

Very small differences in the way a patient lies during radiotherapy treatment for lung or esophageal cancer can have an impact on survival, according to research presented at the European Society for Radiotherapy & Oncology (ESTRO) 37 Conference (Abstract OC-0322). These differences of only a...

ESTRO 37: Ultrahypofractionated Radiotherapy for Prostate Cancer Is Safe and Effective

Radiotherapy given in high doses over a shorter period of time is safe and effective for patients with prostate cancer, according to research from a phase III trial presented at the European Society for Radiotherapy & Oncology (ESTRO) 37 Conference (Abstract OC-0599). The...

ESTRO 37: Handgrip Strength Test May Be a Good Indicator of Survival in Patients With NSCLC

A simple test of handgrip strength may be a good indicator of short- and long-term survival in patients with stage I non–small cell lung cancer (NSCLC), according to new findings presented at the European Society for Radiotherapy & Oncology (ESTRO) 37 Conference (Abstract PV0041)....

ESTRO 37: Elderly Patients With NSCLC May Be Less Likely to Benefit From Concurrent Chemoradiotherapy

An analysis of elderly patients with non–small cell lung cancer (NSCLC) treated in a phase II trial of radiotherapy combined with chemotherapy has shown that they were less likely to benefit than younger patients if the two treatments were given at the same time. These findings were presented ...

ESTRO 37: Brachytherapy for Patients With Cervical Cancer Does Not Increase Risk of Ureteral Stricture

A rare but potentially serious complication following radiation treatment for cervical cancer is a narrowing of the tube that takes urine from the kidneys to the bladder (the ureter), which can lead to kidney damage and sometimes life-threatening infections. This is called ureteral stricture and,...

Link Between Risk of Alzheimer’s Disease and Melanoma, Nonmelanoma Skin Cancers

Although literature demonstrates a decreased risk of Alzheimer's disease in individuals with various cancers—including squamous cell cancers (SCC) and basal cell cancers (BCC)—there is a paucity of literature to substantiate an association between malignant melanoma and...

Pediatric Centers May Improve Survival for Adolescents and Young Adults With ALL

Adolescents and young adults (AYAs) with acute lymphocytic leukemia (ALL) have a survival advantage if they receive treatment at a pediatric cancer center vs an adult center, according to a study published by Muffly et al in Blood Advances. The findings also suggest that treatment at a center...

FDA Accepts sBLA, Grants Priority Review for Nivolumab in Previously Treated Patients With SCLC

On April 18, the U.S. Food and Drug Administration (FDA) accepted for Priority Review a supplemental biologics license application (sBLA) for nivolumab (Opdivo) to treat patients with small cell lung cancer (SCLC) whose disease has progressed after two or more prior lines of therapy. ...

Neuroendocrine Tumor Research Foundation Awards Six Research Grants

THE NEUROENDOCRINE Tumor Research Foundation (NETRF) has awarded six new research grants, totaling about $1.85 million, to leading academic institutions around the world. The grants fund clinical, translational, and basic research in the United States, Australia, Switzerland, and the United...

Fabrice Barlesi, MD, PhD, Receives 2018 Heine H. Hansen Award

THE EUROPEAN SOCIETY for Medical Oncology (ESMO) and the International Association for the Study of Lung Cancer (IASLC) have announced that the 2018 Heine H. Hansen Award was given to Fabrice Barlesi, MD, PhD. The award was presented at the 2018 European Lung Cancer Congress (ELCC 2018) in early...

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 (Cabometyx) for the treatment of patients with metastatic renal cell carcinoma (RCC) who have received one or two prior lines ...

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...

multiple myeloma

Updated International Myeloma Working Group Criteria: Diagnostic Challenges

The ASCO Post is pleased to present Hematology Expert Review, an ongoing feature that quizzes readers on issues in hematology. In this installment, Drs. Abutalib and Landgren review the underlying data that shaped the updated International Myeloma Working Group (IMWG) diagnostic criteria for...

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...

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...

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