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Showing 1001 - 1050New Drug Application Submitted for Ibrutinib in the Treatment of Two B-cell Malignancies
Pharmacyclics, Inc, recently announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the investigational oral Bruton’s tyrosine kinase inhibitor ibrutinib, for two relapsed/refractory B-cell malignancy indications: mantle cell lymphoma (MCL)...
Afatinib as First-line Treatment for Metastatic NSCLC with EGFR Exon 19 Deletions or Exon 21 (L858R) Substitution Mutations
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. Indication On July 12, 2013, afatinib (Gilotrif) was approved for...
Clinical Trials, Crossover, and Clinical Equipoise: A Patient's Perspective
I am writing with regard to two articles on the ethical imperative of clinical equipoise written by Susan O’Brien, MD, and Stephen J. Schuster, MD, and published recently in The ASCO Post.1,2 I was a victim of Pharmacyclics’ policies during one of their randomized ibrutinib trials (PCI-32765)...
California Stem Cell Agency Awards More than $40 Million in New Research Grants, including Funds for Prostate Cancer Research
The California Institute for Regenerative Medicine recently announced approval by the agency’s governing Board, the Independent Citizens Oversight Committee, of $40 million in funding for researchers at 10 institutions as part of its Early Translational IV Research awards. Among the institutions...
ASCO Congratulates QOPI-Certified Practices
QCP™: Recognizing Excellence The QOPI® Certification Program (QCP™) recognizes medical oncology and hematology/oncology practices that are committed to delivering the highest quality of cancer care. QCP evaluates an individual practice’s performance in areas that affect patient care and safety. The ...
FDA Approves Mechlorethamine Gel for Cutaneous T-Cell Lymphoma
Ceptaris Therapeutics, Inc, recently announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for the orphan drug mechlorethamine gel (Valchlor) for the topical treatment of stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma (CTCL) in patients who have ...
Jane Weeks, MD, MSc, National Leader in Outcomes Research, Dies at 61
On September 10, 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 School...
FDA Grants Breakthrough Therapy Status to Entinostat for Advanced Breast Cancer
Syndax Pharmaceuticals Inc announced that the U.S. Food and Drug Administration (FDA) has designated entinostat as a Breakthrough Therapy for the treatment of locally recurrent or metastatic estrogen receptor (ER)-positive breast cancer when added to exemestane in postmenopausal women whose disease ...
FDA Grants Volasertib Breakthrough Therapy Designation in AML
Boehringer Ingelheim Pharmaceuticals, Inc, has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to volasertib, an investigational inhibitor of polo-like kinase (Plk), which being evaluated for the treatment of patients aged 65 or older with...
Pertuzumab in Neoadjuvant Treatment of HER2-Positive Early Breast 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. Indication On September 30, 2013, pertuzumab injection (Perjeta)...
Standardizing the Interpretation of PET Scans: An INR Equivalent
Since its introduction, the positron-emission tomography (PET) scan has shown great potential to improve our ability to care for patients with lymphoma. By demonstrating which masses seen on a computed tomography (CT) scan represent viable tumor, and by identifying viable tumor in places that were...
Improving Quality Measurement in Cancer Care: Policy Recommendations
Quality measurement—how we assess cost and effectiveness of cancer care—cannot be separated from policy decisions that have a profound influence on the overall health-care system. At the recent ASCO Quality Care Symposium, Jennifer L. Malin, MD, PhD, Medical Director for Oncology at WellPoint, Inc, ...
ASCO Launches Formal Development of CancerLinQ™ System
ASCO recently announced that it has initiated development of the full CancerLinQ™ system, a groundbreaking health information technology (HIT) initiative to achieve higher-quality, higher-value cancer care with better outcomes for patients. The announcement was made at a White House Office of...
Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia
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. Indication On November 1, 2013, obinutuzumab (Gazyva) was approved...
New Medical Device Treats Urinary Symptoms Related to Benign Prostatic Hyperplasia
The U.S. Food and Drug Administration has authorized the marketing of the UroLift system, a permanent implant to relieve low or blocked urine flow in men age 50 and older with benign prostatic hyperplasia. As men age, the prostate can become enlarged, also known as benign prostatic hyperplasia....
Ibrutinib in Previously Treated 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. Indication On November 13, 2013, ibrutinib (Imbruvica) was granted...
Breast Cancer Vaccines for Primary Prevention Move Toward Clinical Use
The first candidate vaccine to prevent recurrence of breast cancer entered clinical trials about 8 years ago, and since then, the idea of a vaccine for secondary prevention has gained traction; more such vaccines are now in development. But this fall, it was vaccines for primary prevention that had ...
Bernard J. Tyson Assumes Role of Chairman of Kaiser Permanente
Kaiser Permanente has announced that Bernard J. Tyson officially assumed the role of Chairman of the Boards of Directors of Kaiser Foundation Hospitals and Kaiser Foundation Health Plan, Inc. Mr. Tyson was originally named by the boards in November 2012 to be the organization’s next chairman and...
Scientist/Entrepreneur Selected to Lead Tri-Institutional Therapeutics Discovery Institute
Michael A. Foley, PhD, has been selected to lead the Tri-Institutional Therapeutics Discovery Institute, Inc. (Tri-I TDI), a collaboration of Weill Cornell Medical College, The Rockefeller University, and Memorial Sloan-Kettering Cancer Center that is designed to expedite early-stage drug discovery ...
ASCO Announces Election Results for Terms Beginning June 2014
In addition to the election of Julie M. Vose, MD, MBA, FASCO, as President of the American Society of Clinical Oncology (ASCO) for a 1-year term beginning in June 2015 (see page 85), ASCO has announced four new members who were recently elected to the ASCO Board of Directors and two new members...
Overcoming Drug Development Challenges in the New Era of Cancer Care
While the last 15 years have brought unprecedented advances in oncology drug development, the next 10 years promise to usher in even greater opportunities to realize the goal of precision medicine in the treatment of cancer, providing patients with more effective care and better outcomes. Reaching...
Sorafenib in Differentiated Thyroid Carcinoma
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. New Indication On November 22, 2013, sorafenib (Nexavar) was...
David A. Fullerton, MD, Named President of The Society of Thoracic Surgeons
David A. Fullerton, MD, of the University of Colorado School of Medicine, was elected President of The Society of Thoracic Surgeons (STS) at the Society’s 50th Annual Meeting in Orlando, Florida. “STS has been a preeminent medical society for many years,” said Dr. Fullerton. “It is truly a great...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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 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...
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-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...
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...
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...
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...
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...
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...
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...
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 ...
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...
