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health-care policy

ASCO Addresses Changes in Medicare for 2014

Medicare patients make up 61% of new cancer cases in the United States, and as the population ages, that proportion is expected to rise to 70% by 2030. Over the past decade, the oncology community has been financially challenged by alterations in the Medicare payment system. To address the changes...

leukemia

Ibrutinib for Previously Treated Chronic Lymphocytic Leukemia

On February 12, 2014, ibrutinib (Imbruvica) was granted accelerated approval for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy.1,2 Ibrutinib previously received accelerated approval for the treatment of patients with mantle cell...

City of Hope Names Yuman Fong, MD, Chair, Department of Surgery

City of Hope recently announced the appointment of two new chairs in the Department of Surgery and for the Board of Directors. Yuman Fong, MD, has been named Chair of the Department of Surgery at City of Hope. Dr. Fong comes to City of Hope from Memorial Sloan Kettering Cancer Center in New York,...

Shaw T. Chen, MD, PhD, Joins Polaris Pharmaceuticals

Shaw T. Chen, MD, PhD, has been appointed Executive Vice-President of Regulatory Affairs at Polaris Pharmaceuticals, a subsidiary of Polaris Group. Dr. Chen had previously been with the U.S. Food & Drug Administration (FDA) for over 26 years in new drug development. Most recently he served as...

issues in oncology

Utah Center for Genetic Discovery to Integrate Genome Data Into Patient Care

The USTAR Center for Genetic Discovery is partnering with California-based Omicia, Inc, to make analyzing a patient’s genome as routine as performing a blood test. The center, codirected by Mark Yandell, PhD, and Gabor Marth, DSc, was launched this month with $6 million from the University of Utah...

kidney cancer

A Conversation With Arie Belldegrun, MD, FACS, and Allan Pantuck, MD, MS, FACS

Cancer Immunotherapy What is the role of immunotherapy in the treatment of metastatic renal cell carcinoma? The harnessing of the immune system as an effective treatment for cancer was recently selected by the journal Science as the top scientific Breakthrough of the Year for 2013.1 With this...

lymphoma

FDA Grants Orphan Drug Designation for Anti-CD19 T-Cell Cancer Immunotherapy Product

Kite Pharma, Inc, announced that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development granted orphan drug designation for the company’s lead investigational therapy, an autologous engineered T-cell product that targets CD19 expression on B-cell malignancies, for the...

NCCN Receives $2 Million in Research Funding to Study Nintedanib in Colorectal and Lung Cancers

The National Comprehensive Cancer Network® (NCCN®) Oncology Research Program (ORP) has announced it has been awarded a $2 million grant from Boehringer Ingelheim Pharmaceuticals, Inc. to develop a program to scientifically evaluate and define the safety and clinical effectiveness of the...

breast cancer

PALOMA-1 Trial Finds Palbociclib/Letrozole Doubles Progression-Free Survival in Metastatic Breast Cancer

First-line treatment with the combination of palbociclib plus letrozole extended progression-free survival by approximately 50% in patients with metastatic estrogen receptor–positive, HER2-negative breast cancer, according to final results of the PALOMA-1 trial, a randomized phase II study...

CE Activity Instructions

CE is available on May 1, 2014 and expires on May 1, 2015. A continuing education activity for physicians, physician assistants, nurse practitioners, nurses, pharmacists, and other allied health professionals specializing in the field of oncology. This activity is supported by an unrestricted...

global cancer care

A Vision of Independent Clinical Research in South America

Clinical research is vital for the development and improvement of methods designed to prevent and treat cancer. The majority of clinical trials take place in the developed world through sponsored pharmaceutical research companies.1 The corresponding lack of research in developing countries results...

leukemia

Supplemental New Drug Application Submitted for Ibrutinib in CLL

Pharmacyclics, Inc, and Janssen Biotech, Inc, have announced the submission of a supplemental New Drug Application to the U.S. Food and Drug Administration (FDA), based on data from the randomized, multicenter, open-label phase III RESONATE study, a head-to-head comparison of single-agent ibrutinib ...

Jane Weeks, MD, MSc: August 12, 1952–September 10, 2013

On September 10, 2013, Jane Carrie Weeks, MD, MSc, a prominent researcher at Dana-Farber Cancer Center, died of cancer in her Boston home. She was 61. At the time of her death, Dr. Weeks was Professor of Medicine at Harvard Medical School, Professor of Health Policy and Management at the Harvard...

hematologic malignancies

Siltuximab for Multicentric Castleman’s Disease

In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On April 23, 2014, the anti–interleukin (IL)-6 monoclonal antibody...

colorectal cancer

Panitumumab Plus FOLFOX for KRAS Wild-Type Metastatic Colorectal Cancer

In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Panitumumab (Vectibix) was recently approved by the U.S. Food and...

prostate cancer

Prostate Cancer Biomarkers: Improvement in Predicting Clinically Significant Disease

Prostate cancer will be diagnosed in 233,000 American men in 2014. It is one of the leading causes of death by a cancer (killing ~29,500 men annually).1 Hundreds of thousands of men undergo prostate biopsies each year, most for either benign disease or for a cancer that will never lead to their...

lung cancer

Surgical Biopsy Proves Safe for Selected Patients With Late-Stage Lung Cancer

Researchers at the University of California Davis have determined that surgical biopsies can be safely performed on select patients with late-stage non-small cell lung cancer, which should enhance their access to drugs that target specific genetic mutations such as epidermal growth factor receptor...

lung cancer

Lung-MAP Trial Debuts—Other Personalized Studies Will Follow

Oncologists now have a means of bringing personalized medicine to advanced squamous cell carcinoma, and it involves a biomarker-driven clinical trial that maximizes the chance of successful treatment and new drug approvals. Lung-MAP (Lung Cancer Master Protocol) is a unique concept in which the...

lymphoma

Belinostat for Relapsed/Refractory Peripheral T-Cell Lymphoma

In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs.   On July 3, 2014, belinostat (Beleodaq) was granted accelerated...

gastroesophageal cancer

Rilotumumab Added to First-Line Chemotherapy May Benefit Patients With Advanced Gastric or Esophagogastric Junction Adenocarcinoma

Hepatocyte growth factor (HGF) and its receptor MET have been found to promote the proliferation, migration, and survival of tumor cells and to play a role in gastric cancer. In a phase II study reported in The Lancet Oncology, Timothy Iveson, MD, of the University Hospital Southampton NHS...

hepatobiliary cancer

Orphan Drug Designation Granted for New Agent in Hepatocellular Carcinoma

CASI Pharmaceuticals, Inc, announced that its investigational agent ENMD-2076 has received orphan drug designation from the U.S. Food & Drug Administration (FDA) for the treatment of hepatocellular carcinoma. ENMD-2076 is an orally active Aurora A/angiogenic kinase inhibitor with a unique...

bladder cancer

Ongoing Clinical Trials Actively Recruiting Patients With Bladder Cancer

The information in this Clinical Trials Resource Guide includes actively recruiting clinical studies for patients with bladder cancer. The list includes randomized and nonrandomized phase 0 to III studies as well as observational clinical trials evaluating new therapies, surgical techniques, and...

lung cancer

New Clinical Study Aims to Investigate the Genomics of Young Lung Cancer

The Addario Lung Cancer Medical Institute (ALCMI) recently launched a new study, the Genomics of Young Lung Cancer, to understand why lung cancer occurs in young adults, who quite often are athletic, never smokers and do not exhibit any of the known lung cancer genetic mutations. ALCMI, a...

leukemia

Ibrutinib in Previously Treated CLL and CLL With 17p Deletion

In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs.   On July 28, 2014, the approved use of ibrutinib (Imbruvica) in...

leukemia
lymphoma

Idelalisib for Relapsed CLL in Combination With Rituximab and for Relapsed Follicular Lymphoma or Small Lymphocytic Lymphoma

In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs.   On July 23, 2014, idelalisib (Zydelig) was approved for  use in...

NIH Awards $14.5 Million to Research Groups Studying Newest DNA Sequencing Techniques

A number of microsized technologies, such as nanopores and microfluidics, are among the approaches researchers will use to develop high-quality, low-cost DNA sequencing technology through new grants from the National Institutes of Health (NIH). The grants, which total approximately $14.5 million to ...

gynecologic cancers

Bevacizumab in Persistent, Recurrent, or Metastatic Cervical Cancer

In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs.   On August 14, 2014, bevacizumab (Avastin) was approved for the...

breast cancer

Palbociclib Expanded Access Program Open to Eligible Breast Cancer Patients

Pfizer Inc announced that the company has initiated a multicenter, open-label expanded access program in the United States for the investigational oral CDK 4/6 inhibitor, palbociclib. Through the program, palbociclib is being made available for use in combination with ­letrozole for postmenopausal...

multiple myeloma

Bortezomib Retreatment in Multiple Myeloma

In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On August 8, 2014, the approved use of bortezomib (Velcade) in...

Roswell Park Researchers Awarded Nearly $5 Million to Support Research Projects

Several faculty members at Roswell Park Cancer Institute have been awarded nearly $5 million in grant funding from public and private organizations to further their efforts to find new and better ways to detect and treat cancer and improve patients’ quality of life. The 13 awards, including two for ...

colorectal cancer
lung cancer
gastroesophageal cancer

Researchers at Roswell Park Receive Grants to Study New Anticancer Agent in Lung, Colorectal, and Gastrointestinal Cancers

Researchers at Roswell Park Cancer Institute have been awarded three of four grants by the National Comprehensive Cancer Network (NCCN) Oncology Research Program to evaluate and define the clinical effectiveness of the investigational compound nintedanib. Nintedanib is an investigational...

prostate cancer

Enzalutamide in Metastatic Castration-Resistant Prostate Cancer

In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs.   On September 10, 2014, the androgen receptor inhibitor...

hematologic malignancies

Louis J. DeGennaro, PhD, Named President and Chief Executive Officer of The Leukemia & Lymphoma Society

The Leukemia & Lymphoma Society has announced that Louis J. DeGennaro, PhD, has been appointed as President and Chief Executive Officer, effective immediately. “Dr. DeGennaro has tirelessly dedicated himself for almost a decade of service to the Leukemia & Lymphoma Society mission and to...

Robert S. Miller, MD, FACP, FASCO, Joins ASCO as Medical Director of Society’s Institute for Quality

Robert S. Miller, MD, FACP, ­FASCO, Assistant Professor of Oncology and Oncology Medical Information Officer at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, has been named Medical Director of the Institute for Quality (iQ) of the American Society of Clinical Oncology (ASCO). Dr....

head and neck cancer

Lymphatic Mapping Agent Receives Orphan Drug Designation for Head and Neck Cancers

Navidea Biopharmaceuticals, Inc, recently announced that technetium 99m tilmanocept (Lymphoseek Injection) has been granted Orphan Drug Designation by the U.S. Food & Drug Administration (FDA) for use in sentinel lymph node detection in patients with cancer of the head and neck. The designation ...

CancerLinQ™ Receives Major Commitment From CTCA®

The Conquer Cancer Foundation of ASCO has received a major commitment of support for the development of CancerLinQ™ from Cancer Treatment Centers of America, Inc (CTCA), a national network of five cancer hospitals. The donation is the largest received to date in support of CancerLinQ, a...

breast cancer

Metastatic Breast Cancer Alliance Report Finds Research for the Disease Is Underfunded, Details Gaps in Patient Services

In October, the newly formed Metastatic Breast Cancer Alliance (MBCA) released its report, Changing the Landscape for People Living With Metastatic Breast Cancer, which details some disturbing findings. Following a yearlong analysis of 224 clinical trials, 2,281 funded research projects in...

colorectal cancer

Clinical Trials Actively Recruiting Patients With Colon or Rectal Cancer

The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies of people with colon or rectal cancer in the newly diagnosed and metastatic settings. The studies include phase I, Ib, II, observational, and interventional trials investigating new drug...

issues in oncology
cost of care

Expert Panel Explores Cost, Value, and Patient-Centered Care in Cancer Treatment

In assessing a cancer treatment, cost and value are two key factors. So how, the moderator asked, do they enter into your everyday decisions? Tanisha Carino, PhD, Executive Vice President of Avalere Health, was speaking to a clinical oncologist, a patient advocate, a pharma executive, and a health...

issues in oncology

Expert Panels Offer Five Proposals to Address Challenges in Regulating, Implementing Next-Generation Sequencing

At the third annual Blueprint for Drug/Diagnostic Co-Development forum, cohosted by Friends of Cancer Research in Washington, DC, and the Alexandria Center for Life Science in New York, two panels tackled considerations in simultaneous development of drugs and companion diagnostics. Friends of...

lymphoma

Bortezomib in Previously Untreated Mantle Cell Lymphoma

In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs.   On October 9, 2014, bortezomib (Velcade) was granted approval for ...

breast cancer

Noteworthy Abstracts From the Breast Cancer Symposium Include Studies of Novel Therapies and of the Impact of Disease Subtypes on Outcomes

More than 150 oral and poster presentations were featured at the 2014 Breast Cancer Symposium, held September 4–6 in San Francisco. The multidisciplinary meeting is sponsored by ASCO, the American Society of Breast Disease, American Society of Breast Surgeons, American Society for Radiation...

Raising Consciousness About Drug Costs: A Call to Action

As medical oncologists working in chemotherapy utilization management (Oncology Analytics, Inc), my colleagues and I find ourselves daily in the center of the drug-cost maelstrom. While it is encouraging to see that more attention is being paid in the popular and medical press to this...

Bevacizumab Plus Chemotherapy in Platinum-Resistant Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On November 14, 2014, bevacizumab (Avastin) in combination with...

Working Stiff: Two Years, 262 Bodies, and the Making of a Medical Examiner

Bookmark Title: Working Stiff: Two Years, 262 Bodies, and the Making of a Medical Examiner Authors: Judy Melinek, MD, and T.J. Mitchell Publisher: Scribner, a Division of Simon & Schuster, Inc Publication Date: August 2014 Price: $25.00; hardcover, 272 pages   Just as the sun came up over a...

health-care policy

Policy Issues in Molecularly Targeted Therapy: The Science, the Money, the Applications

In the past decade, much new knowledge about the molecular underpinnings of cancer has accumulated, and the array of molecular aberrations in each individual tumor can be assessed through genomic sequencing and other tests. The rationale for and feasibility of developing molecularly targeted...

gynecologic cancers

Gardasil 9 Adds Protection Against Cancer Caused by Additional Human Papillomavirus Types

In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs.   On December 10, 2014, Gardasil 9 (human papillomavirus 9-valent...

leukemia

Blinatumomab Achieves Complete Molecular Responses in Majority of B-Cell Leukemia Patients

Results from the international phase II BLAST study show that one cycle of blinatumomab (Blincyto) immunotherapy achieved complete minimal residual disease response in 78% of patients with acute lymphoblastic leukemia.1 Complete minimal residual disease response was achieved in 80% of patients...

neuroendocrine tumors

Lanreotide in Gastroenteropancreatic Neuroendocrine Tumors

In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs.   On December 16, 2014, lanreotide (Somatuline depot injection) was ...

breast cancer

Ultrasonography Detects Mammographically Occult Invasive Cancers

Mammograms often miss occult breast cancers concealed in dense breasts. Women with dense breasts represent about 40% to 50% of women who undergo mammography screening. In some states and centers in the United States, women with dense breasts are routinely offered ultrasonography following a...

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