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...
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...
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 ...
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...
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...
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, 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....
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 ...
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...
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...
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...
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...
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...
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 ...
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...
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...
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...
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...
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...
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...
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...
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 ...
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...
Ductal carcinoma in situ, which accounts for 30% of all newly diagnosed breast cancers, does not always evolve into a lesion with metastatic potential. Only a proportion of these cases will progress to invasive breast cancer, but up until recently, it has not been possible to identify reliably...
While some seek peace in the Middle East through political means, others are looking to help patients with cancer find peace through palliative care. This endeavor is bringing oncology professionals together across the region’s national borders and cultural boundaries to implement solutions and...
Amgen and its subsidiary Onyx Pharmaceuticals, Inc, announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) carfilzomib (Kyprolis) to seek approval for the treatment of patients with relapsed multiple myeloma who have received at least...
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 3, 2014, blinatumomab (Blincyto) was granted...
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 January 29, 2015, the U.S. Food and Drug Administration (FDA)...
INSIDE THE BLACK BOX is an occasional column offering insight into the U.S. Food and Drug Administration (FDA) and its policies and procedures. In this installment, former clinical pharmacology team leader Julie Bullock, PharmD, and current team leader Nitin Mehrotra, PhD, discuss how...
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 February 3, 2015, palbociclib (Ibrance) was granted...
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 February 13, 2015, lenvatinib (Lenvima) was approved for the...
Biliary tract cancers are challenging, but a large genomic profiling study has identified potentially clinically relevant genomic alterations in up to two-thirds of patients.1 “The diverse landscape of clinically relevant genomic alterations in biliary tract cancers can serve as targets for...
The information contained in this Clinical Trials Resource Guide includes actively recruiting observational, interventional, phase I, phase II, and phase III clinical studies for patients with newly diagnosed or recurrent esophageal cancer. All of the studies are listed on the National Institutes...
Nonprofit Global Oncology, Inc (GO) announced the launch of the Global Cancer Project Map, a novel online resource and virtual information exchange connecting the global cancer community. Developed by Global Oncology in collaboration with the National Cancer Institute (NCI) Center for Global...
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 March 6, 2015, the granulocyte colony-stimulating factor...
The search is on in prostate cancer to identify predictive and prognostic biologic and genomic markers that go beyond traditional ones. Several groups are working in this area. One marker that has received much attention is a splice abnormality in the androgen receptor (AR) called AR-V7. Two...
Hair loss remains one of the most dreaded side effects of chemotherapy, particularly for women. Scalp cooling caps worn by patients during chemotherapy infusion and for brief periods of time before and after offer these patients an option to preserve 50% or more of the hair on their heads. Although ...
The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies for patients with newly diagnosed or relapsed or refractory neuroblastoma. The studies include pilot, observational, phase I, phase II, and phase III trials investigating single-agent and...
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of evofosfamide (TH-302), administered in combination with gemcitabine, for previously untreated patients with metastatic or locally advanced unresectable pancreatic cancer. Evofosfamide is an...
For 2 decades, the NCCN Guidelines® have been recognized as the standard of cancer care in the United States, combining evidence, experience, and choice, so that multidisciplinary cancer treatment teams—including patients—are empowered to make informed decisions about cancer care,” said Robert W....
At the end of the day, I’m still a kid from South Philly,” Andrew C. von Eschenbach, MD, former Director of the National Cancer Institute (NCI) and Commissioner of the U.S. Food and Drug Administration (FDA), told The ASCO Post. Dr. von Eschenbach is the product of a closely knit yet culturally...
Kenneth C. Frazier, JD, Chairman and CEO of Merck & Co., Inc., was elected Chairman of the Board of the Pharmaceutical Research and Manufacturers of America (PhRMA). Mr. Frazier formerly held the position of Chairman-Elect and succeeds Ian C. Read, Chairman and CEO of Pfizer, Inc. New Officers ...
An analysis of Gynecologic Oncology Group (GOG) studies recently reported in the Journal of Clinical Oncology by Tewari and colleagues and reviewed in this issue of The ASCO Post showed a survival benefit of intraperitoneal chemotherapy vs intravenous chemotherapy over long-term follow-up in women...
Pembrolizumab (Keytruda) is making inroads into head and neck cancer, with encouraging results in heavily pre-treated patients with recurrent or metastatic squamous cell carcinoma of the head and neck, according to a report on the expansion-cohort KEYNOTE-012 study presented at the 2015 ASCO...
In a study reported in The Lancet Oncology, Brian Rini, MD, of the Cleveland Clinic Taussig Cancer Institute, and colleagues developed a 16-gene assay and recurrence score that predicted postoperative outcome in patients with stage I to III clear cell renal cell carcinoma.1 Development Phase In the ...
The Conquer Cancer Foundation of ASCO presented more than $6.7 million in grants and awards to more than 200 promising oncology researchers at the 2015 ASCO Annual Meeting. The Conquer Cancer Foundation and ASCO congratulate the recipients on their contributions to the field of oncology and offer...
Janssen Biotech, Inc, announced the opening of a daratumumab expanded access program for eligible patients in the United States. Daratumumab is an investigational human anti-CD38 monoclonal antibody being evaluated in clinical trials as a treatment for patients with multiple myeloma. The...
The value proposition in health care is often represented with the following equation: Value = Outcomes/Cost. The simplicity of this equation, however, belies the complexity of its parts, which are the contributions of multiple stakeholders with unique perspectives. A session presented at the 2015...
Question 1: What is the best first step in management of this patient? Correct Answer: C. Start plasma exchange. Expert Perspective Although distinguishing among thrombotic thrombocytopenic purpura, typical hemolytic uremic syndrome, and atypical hemolytic uremic syndrome (see Table 1 in the...
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 24, 2015, carfilzomib (Kyprolis) was approved for use in...