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Showing 1251 - 1300FDA Grants sBLA to Pembrolizumab for the Treatment of Relapsed or Refractory Classical Hodgkin Lymphoma
The U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for pembrolizumab (Keytruda), an anti–programmed cell death protein 1 (PD-1) therapy, for the treatment of patients with refractory classical Hodgkin lymphoma or for...
FDA Grants Priority Review to Pembrolizumab for New Indication in Microsatellite Instability–High Cancer
On November 28, the U.S. Food and Drug Administration (FDA) accepted for review the supplemental Biologics License Application (sBLA) for pembrolizumab (Keytruda) for the treatment of previously treated patients with advanced microsatellite instability–high (MSI-H) cancer. The FDA granted...
Michael O’Connell, MD, Receives the 2016 ACCC Clinical Research Award
Michael O’Connell, MD, received the Association of Community Cancer Centers (ACCC) 2016 Clinical Research Award in recognition of the significant and positive impact of his research on the oncology patient, family, and the community. ACCC President Jennie R. Crews, MD, MMM, FACP, accepted the...
Pembrolizumab in First-Line Treatment of Metastatic Non–Small Cell Lung Cancer
On October 24, 2016, pembrolizumab (Keytruda) was approved for use in patients with metastatic non–small cell lung cancer (NSCLC) whose tumors have high programmed cell death ligand 1 (PD-L1) expression (tumor proportion score ≥ 50%) as determined by a U.S. Food and Drug Administration...
At ESMO 2016, Many Phase III Trials Fail to Meet Primary Endpoints
The 2016 European Society for Medical Oncology (ESMO) Congress revealed many important positive findings from key trials in a number of tumor types, but many highly anticipated phase III trials in advanced disease failed to meet their primary endpoints. The ASCO Post has summarized several of these ...
Anti–PD-1 Contenders in Advanced Urothelial Cancer
Immunotherapy with anti–PD-1 (programmed cell death protein 1) and anti–PD-L1 (programmed cell death ligand 1) agents continues to advance in metastatic urothelial cancer, with positive showings in two clinical trials presented at the 2016 European Society for Medical Oncology (ESMO) Congress. The...
Numerous ESMO Presentations Focused on Anti–PD-1 Therapy in Lung Cancer and Melanoma
The 2016 European Society for Medical Oncology (ESMO) Congress was jam-packed with studies of the anti–programmed cell death protein 1 (PD-1) antibodies in non–small cell lung cancer and melanoma, where they have clearly changed the treatment paradigm. Here is a roundup of some of those trials,...
Pembrolizumab as First-Line Therapy in Metastatic NSCLC: Practice-Changing Implications of KEYNOTE-024 Trial
We are in the midst of a paradigm shift in lung cancer. In the past 2 years, the anti–programmed cell death protein 1 (anti–PD-1) inhibitors nivolumab (Opdivo) and pembrolizumab (Keytruda) were found to improve overall survival in the second-line setting compared with docetaxel for patients with...
Pembrolizumab Improves Outcomes vs Platinum-Based Chemotherapy in Advanced PD-L1–Positive NSCLC
In the phase III KEYNOTE-024 trial reported in The New England Journal of Medicine by Martin Reck, MD, PhD, of the German Center of Lung Research, Grosshansdorf, and colleagues, pembrolizumab (Keytruda) significantly improved progression-free and overall survival vs platinum-based chemotherapy in...
FDA Approves Pembrolizumab as First-Line Treatment for PD-L1–Positive Non–Small Cell Lung Cancer
On October 24, 2016, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors express programmed cell death ligand 1 (PD-L1) as determined by an FDA-approved test. This is the first...
Higher Complete Pathologic Regression Rate With Neoadjuvant Docetaxel- vs Epirubicin-Based Triplets in Gastric/Gastroesophageal Junction Cancer
In the phase II portion of a German phase II/III trial (FLOT4) reported in The Lancet Oncology, Al-Batran et al found that preoperative docetaxel-based vs anthracycline-based triplet therapy produced a higher complete histopathologic regression rate in patients with resectable gastric or...
Gut Microbes Linked to Immunotherapy Response in Patients With Melanoma
Patients with malignant melanoma are more likely to respond to immunotherapy treatment if they have greater diversity in their gut bacteria, according to new research presented by Wargo et al at the National Cancer Research Institute's (NCRI) Cancer Conference in Liverpool, United Kingdom....
KEYNOTE-045 Trial Finds Pembrolizumab Improves Survival Over Chemotherapy in Advanced Urothelial Cancer
The phase III KEYNOTE-045 trial, investigating the use of the anti–PD-1 (programmed cell death protein 1) therapy pembrolizumab (Keytruda) in patients with previously treated advanced urothelial cancer, met the primary endpoint of overall survival, according to a news release issued by Merck. In...
Pembrolizumab, but Not Nivolumab, Improves Outcomes in Front-Line Setting for PD-L1–Positive Advanced NSCLC
Checkpoint inhibitors have revolutionized the treatment of advanced non–small cell lung cancer (NSCLC), but evidence of their benefit was restricted to the second-line setting. However, early-phase trials with both pembrolizumab (Keytruda) and nivolumab (Opdivo) demonstrated favorable results in...
Pembrolizumab Plus Chemotherapy Improves Outcomes Over Chemotherapy Alone in Advanced NSCLC
Combining immunotherapy with a standard chemotherapy doublet appears to be an attractive option for the front-line treatment of advanced nonsquamous non–small cell lung cancer (NSCLC), according to the results of a phase II study presented at the 2016 European Society for Medical Oncology (ESMO)...
FDA Approves Pembrolizumab as First-Line Treatment for PD-L1–Positive Non–Small Cell Lung Cancer
On October 24, 2016, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors express programmed cell death ligand 1 (PD-L1) as determined by an FDA-approved test. This is the...
KEYNOTE-045 Studying Pembrolizumab in Advanced Bladder Cancer Meets Primary Endpoint and Stops Early
Merck announced October 21, 2016, that the phase III KEYNOTE-045 trial investigating the use of pembrolizumab (Keytruda), the company’s anti–PD-1 (programmed cell death protein 1) therapy in patients with previously treated advanced urothelial cancer, met the primary endpoint of overall ...
Pembrolizumab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
As reported in the Journal of Clinical Oncology by Laura Q. Chow, MD, of the University of Washington, and colleagues, a fixed-dose reduced-frequency pembrolizumab (Keytruda) regimen produced durable responses in the phase IB KEYNOTE-012 expansion cohort of patients with recurrent or metastatic...
New American Cancer Society Report Reveals Gaps, Identifies Unique Barriers in Pediatric Cancer Research
A first-of-its-kind joint report from the American Cancer Society and the Alliance for Childhood Cancer has compiled the latest information related to pediatric cancer, including statistics and trends; a current list of drugs used to treat pediatric cancers; ongoing pediatric cancer clinical...
Expert Point of View: Olivier Michielin, MS, MD, PhD
The paper’s invited discussant was Olivier Michielin, MS, MD, PhD, Head of Personalized Analytical Oncology and the Melanoma Clinic at Lausanne University Hospital in Switzerland. He called the findings of the European Organisation for Research and Treatment (EORTC) 18071 trial a “new landmark in...
Adding Pembrolizumab to Carboplatin/Pemetrexed Seems to Improve Response in Advanced Nonsquamous NSCLC
As reported by Langer et al in The Lancet Oncology, findings in a phase II cohort of the multicohort KEYNOTE-021 study showed that the addition of first-line pembrolizumab (Keytruda) to carboplatin/pemetrexed (Alimta) significantly increased the response rate in patients with advanced nonsquamous...
ESMO 2016: First-Line Pembrolizumab Plus Chemotherapy Significantly Improves Outcomes in Advanced NSCLC
The addition of the programmed cell death protein 1 (PD-1) antibody pembrolizumab (Keytruda) to standard first-line chemotherapy for treatment-naive advanced non–small cell lung cancer significantly improves response rates and progression-free survival, Langer et al reported at the 2016...
Vice President Biden Delivers Cancer Moonshot Report, Announces Public and Private Sector Actions to Advance Cancer Moonshot Goals
Today in the Oval Office, Vice President Joe Biden delivered the Cancer Moonshot report to the President and the American public. The report summarizes the work of the Cancer Moonshot Task Force since its creation in January and lays out the Vice President’s strategic plan for transforming...
First-Line Pembrolizumab Improves Survival vs Platinum-Based Chemotherapy in Advanced PD-L1–Positive NSCLC
Pembrolizumab (Keytruda) significantly improved progression-free and overall survival vs platinum-based chemotherapy in patients with previously untreated advanced non–small cell lung cancer (NSCLC) with ≥ 50% PD-L1 (programmed cell death ligand 1) expression and no sensitizing EGFR...
Using Watson to Analyze Genomic Data to Personalize Treatment for Patients With Cancer
Three years ago, IBM’s Watson supercomputer was best known for defeating two former champions on the TV game show Jeopardy! Today, it is grabbing headlines for becoming an important assistant in cancer care. Able to read and understand millions of pages of text within seconds, Watson caught the...
Is Pembrolizumab Active Against Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma?
As reported in the Journal of Clinical Oncology by Chow et al, a fixed-dose reduced-frequency pembrolizumab (Keytruda) regimen produced durable responses in the phase IB KEYNOTE-012 expansion cohort of patients with recurrent or metastatic head and neck squamous cell carcinoma. The response rate...
ASCO Continues Active Involvement in Cancer Moonshot
This summer, ASCO continued its active involvement in Vice President Joe Biden’s Cancer Moonshot Initiative. ASCO joined the Vice President at the formal launch of the moonshot earlier this year, and since then, has discussed research and policy proposals to advance discovery in cancer treatment...
The Role of Music Therapy in Cancer Care
Music therapy, an established adjuvant to standard cancer care, is offered in a growing number of cancer centers throughout the United States and internationally. Defined by the American Music Therapy Association (AMTA) as “the evidence-based use of music interventions to accomplish individual...
AACR and CEO Margaret Foti, PhD, MD (hc) Honored With PHL Life Sciences Ultimate Solution Award
The American Association for Cancer Research (AACR) and its Chief Executive Officer, Margaret Foti, PhD, MD (hc), were honored with the PHL Life Sciences Ultimate Solution Award for their significant contributions to and impact on the field of cancer research. The award is presented annually by PHL ...
FDA Grants Priority Review to Pembrolizumab Supplemental Biologics License Application for First-Line Treatment of Advanced NSCLC
The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for pembrolizumab (Keytruda), an anti–PD-1 (programmed cell death protein 1) therapy, for the first-line treatment of patients with advanced non–small cell lung cancer...
Reducing Drug Costs by Increasing Science-Driven Drug Discovery
For several years now, the American health-care system has been undergoing a transformation. Innovative ideas are being explored, new systems continue to be created, and millions of lives have been impacted. As health-care providers and research engines, academic institutions have an opportunity...
New American Cancer Society Report Reveals Gaps in Pediatric Cancer Research
A first-of-its-kind joint report from the American Cancer Society and Alliance for Childhood Cancer has compiled the latest information related to pediatric cancer, including statistics and trends; a current list of drugs used to treat pediatric cancers; ongoing pediatric cancer clinical trials;...
Venetoclax Produces High Response Rate in Relapsed or Refractory CLL With 17p Deletion
In a pivotal phase II study reported in The Lancet Oncology, Stephan Stilgenbauer, MD, of Ulm University, Germany, and colleagues found that the BCL2 inhibitor venetoclax (ABT-199) produced a high response rate in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) with the 17p ...
FDA Grants Priority Review to Pembrolizumab for First-Line Treatment of Advanced NSCLC
The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for pembrolizumab (Keytruda), an anti–PD-1 (programmed cell death protein 1) therapy, for the first-line treatment of patients with advanced non–small...
Use of Pembrolizumab in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma After Platinum-Containing Therapy
On August 5, 2016, pembrolizumab (Keytruda) was granted accelerated approval for treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma and disease progression on or after platinum-containing chemotherapy.1,2 As a condition of the accelerated approval, Merck is...
FDA Approves Pembrolizumab for Metastatic Head and Neck Squamous Cell Carcinoma
On August 5, 2016, the U. S. Food and Drug Administration granted accelerated approval to pembrolizumab (Keytruda), an anti–PD-1 (programmed cell death protein 1) therapy, for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma with disease progression on or ...
Indiana University School of Medicine Receives $2 Million Gift
The children of Indianapolis philanthropists Sidney and Lois Eskenazi have made a $2 million gift to the Indiana University School of Medicine to be used to recruit a highly accomplished researcher focused on discovering new ways to treat, diagnose, and prevent cancer. The gift, to honor their...
Low-Dose CT Screening: New Solid Nodules and Lung Cancer Probability
As reported by Walter et al in The Lancet Oncology, incidence screening with low-dose computed tomography (CT) in high-risk individuals detected new solid nodules in approximately 5% to 7% at second and third screenings in the ongoing Dutch-Belgian NELSON trial. Larger nodule size was associated...
FDA Approves Pembrolizumab for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma After Platinum-Containing Chemotherapy
The U.S. Food and Drug Administration (FDA) has approved pembrolizumab (Keytruda), an anti–PD-1 (programmed cell death protein 1) therapy, at a fixed dose of 200 mg every 3 weeks, for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma with...
Reduced-Intensity Related-Donor Haploidentical vs HLA-Matched Sibling-Donor Hematopoietic Cell Transplantation in Lymphoma
In an analysis of the observational database of the Center for International Blood and Marrow Transplant Research reported in the Journal of Clinical Oncology, Nilanjan Ghosh, MD, PhD, of Levine Cancer Institute, Carolinas Healthcare System, Charlotte, North Carolina, and colleagues found that...
ASCO and CancerLinQ Participated in Landmark Cancer Moonshot Summit
ASCO Chief Executive Officer Clifford A. Hudis, MD, FASCO, and CancerLinQ LLC Chief Executive Officer Kevin Fitzpatrick attended Vice President Joe Biden’s Cancer Moonshot Summit at Howard University on Wednesday, June 29, 2016. Along with leaders and stakeholders across the cancer research and...
Fentanyl Nasal Spray Now Available at a Dose of 300 µg for Treatment of Breakthrough Cancer Pain
Fentanyl (Lazanda) nasal spray, a schedule II narcotic, is now available at a 300-µg dose to treat breakthrough cancer pain, offering physicians another titration option for dosing flexibility. The new strength can help physicians more easily and accurately target the appropriate dose for patients, ...
New ASTRO Clinical Practice Statement Updates Treatment Standard for Rectal Cancer
The American Society for Radiation Oncology (ASTRO) recently issued a new clinical practice statement, “Appropriate Customization of Radiation Therapy for Stage II and III Rectal Cancer: An ASTRO Clinical Practice Statement Using the RAND/UCLA Appropriateness Method.” An executive...
ASCO and MECC Sponsor International Palliative Care Workshop in Kazakhstan
ASCO recently collaborated with the Middle East Cancer Consortium (MECC) to provide a 3-day International Palliative Care Workshop in Kazakhstan for health-care professionals, advocates, and volunteers in the former capital of Almaty. Dilyara Kaidarova, MD, PhD, Director of the Almaty Oncology...
Quick Takes on Promising New Approaches to Treating Breast Cancer
At the 2016 ASCO Annual Meeting, researchers reported encouraging results for several new drugs and treatment strategies for breast cancer. The ASCO Post brings you brief summaries of a select few. Abemaciclib Trial The cyclin-dependent kinase 4/6 (CDK4/6) inhibitor abemaciclib produced responses...
HHS Announces Physician Groups Selected for Initiative Promoting Better Cancer Care
The U.S. Department of Health and Human Services (HHS) has announced that it has selected nearly 200 physician group practices and 17 health insurance companies to participate in a care delivery model that supports and encourages higher quality and more coordinated cancer care. The Medicare arm of...
Charting a New Course at the FDA
In February, after serving for a year as the U.S. Food and Drug Administration’s (FDA’s) Deputy Commissioner for Medical Products and Tobacco, Robert M. Califf, MD, MACC, was named the agency’s Commissioner of Food and Drugs. Prior to his appointment at the FDA, Dr. Califf was the Donald F....
Fentanyl Nasal Spray Now Available at a Dose of 300 μg for Treatment of Breakthrough Cancer Pain
Fentanyl (Lazanda) nasal spray, a schedule II narcotic, is now available at a 300-μg dose to treat breakthrough cancer pain, offering physicians another titration option for dosing flexibility. The new strength can help physicians more easily and accurately target the appropriate dose for...
The Age of the Atomic Hematologists/Oncologists
Every longstanding culture has ages: The Minoans were followed by the Mycenaeans and, later, the Hellenistic peoples. And so it is with hematology/oncology. A descriptive age dominated predominately by histopathologists was followed by an age of experimentalists. Development of the atomic bombs...
Increased Risk of Gallbladder Cancer May Be Associated With Consuming Large Amounts of Sweetened Beverages
A large prospective Swedish study reported by Susanna C. Larsson, PhD, of the Unit of Nutritional Epidemiology at the Institute of Environmental Medicine at Karolinska Institutet in Stockholm, Sweden, and colleagues found a 2.2-fold increased risk of gallbladder cancer in people who consumed two or ...
