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Showing 2551 - 2600Prolonged Progression-Free Survival With Addition of Palbociclib to Fulvestrant in HER2-Negative Metastatic Breast Cancer
As reported in The Lancet Oncology by Massimo Cristofanilli, MD, of the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, and colleagues, the final results of the phase III PALOMA-3 trial showed that the addition of the CDK4/CDK6 inhibitor palbociclib (Ibrance) to fulvestrant...
Anti–PD-1 Inhibitor Gains Foothold in Merkel Cell Carcinoma
Immunotherapy marches on! One of the latest frontiers for checkpoint inhibitors is the treatment of Merkel cell carcinoma, a rare but aggressive type of cancer. First-line therapy with pembrolizumab (Keytruda)—an anti–PD-1 (programmed cell death protein 1) inhibitor—achieved an objective response...
ASCO Applauds the FDA for Regulating E-Cigarettes
ASCO President Julie M. Vose, MD, MBA, FASCO, issued the following statement in response to the U.S. Food and Drug Administration’s (FDA) move to regulate electronic cigarettes. “ASCO applauds the FDA for exercising its congressionally mandated authority to regulate cigars, hookah tobacco,...
Statement From FDA Commissioner Robert Califf, MD, on the Release of the Final Individual Patient Expanded Access Form
On June 2, 2016, U.S. Food and Drug Administration (FDA) Commissioner Robert Califf, MD, issued the following statement on the release of the final individual patient expanded access form. “Today, the FDA finalized its efforts to streamline the process used by physicians to request expanded...
Moving the Needle on HPV Vaccination
In 2012–2013, members of the President’s Cancer Panel (prescancerpanel.cancer.gov) focused their efforts on accelerating widespread acceptance of and use of approved human papillomavirus (HPV) vaccines to prevent cancer. The topic is important, because HPVs cause most cases of cervical cancer and...
Daratumumab Hits the Mark in Early Relapsed Multiple Myeloma
For relapsed or refractory multiple myeloma, daratumumab (Darzalex), combined with bortezomib (Velcade) and dexamethasone, reduced relapses by 61% in the phase III CASTOR study reported at the 2016 ASCO Annual Meeting.1 “The results are unprecedented in a randomized study comparing a novel...
Vali A. Papadimitrakopoulou, MD, and Gideon Michael Blumenthal, MD, on NSCLC: An Updated Pooled Analysis
Vali A. Papadimitrakopoulou, MD, of MD Anderson Cancer Center, and Gideon Michael Blumenthal, MD, of the US Food and Drug Administration, discuss milestone analyses with immune checkpoint inhibitors, targeted therapy, and standard therapy in metastatic non–small cell lung cancer trials submitted to ...
Investigational Drug Abemaciclib Shows Promising Activity Against Several Cancer Types in Early Study
An experimental CDK inhibitor, abemaciclib, yielded encouraging and durable results against several different types of cancers, including breast cancer, lung cancer, glioblastoma, and melanoma, according to a report published by Patnaik et al in Cancer Discovery. The results of the trial supported ...
ASCO 2016: Rucaparib Shows Clinical Benefit in BRCA-Mutated Pancreatic Cancer
The targeted PARP inhibitor rucaparib, which has demonstrated robust clinical activity in patients with ovarian cancer who have a BRCA mutation, also showed promise in previously treated patients with pancreatic cancer who have the mutation, according to results from a phase II clinical study...
ASCO 2016: Liquid Biopsy May Help Guide Treatment Decisions for Patients With Advanced Solid Tumors
A large-scale genomic analysis found that patterns of genetic changes detected in blood samples (liquid biopsy) closely mirror those identified in traditional tumor biopsy. With blood samples from more than 15,000 patients and 50 different tumor types, this is one of the largest cancer genomics...
ASCO 2016: Precision Medicine Approach May Expand Therapeutic Options for Patients
Researchers reported encouraging early results from a phase II trial that matches patients with molecular abnormalities in the tumor to corresponding targeted treatments. Twenty-nine of 129 patients with 12 different types of advanced cancers responded to drugs outside of U.S. Food and Drug...
ASCO 2016: Biosimilar Shows Comparable Efficacy and Safety to Trastuzumab in HER2-Positive Metastatic Breast Cancer
A biosimilar trastuzumab antibody (MYL-1401O) is comparable in efficacy and safety to trastuzumab (Herceptin) in women with HER2-positive advanced breast cancer, according to a randomized phase III study. The response rates were comparable among women who received trastuzumab and among...
Statement from FDA Commissioner Robert Califf, MD, on the Release of the Final Individual Patient Expanded Access Form
“Today, the U.S. Food and Drug Administration (FDA) finalized its efforts to streamline the process used by physicians to request expanded access, often called ‘compassionate use,’ to investigational drugs and biologics for their patients. As a physician, I understand the...
FDA Approves EGFR Mutation–Detecting Blood Test for Non–Small Cell Lung Cancer
The U.S. Food and Drug Administration (FDA) today approved the cobas EGFR Mutation Test v2, a blood-based companion diagnostic for the epidermal growth factor receptor (EGFR) inhibitor erlotinib (Tarceva). This is the first FDA-approved, blood-based genetic test that can detect EGFR gene mutations...
FDA Approves New Diagnostic Imaging Agent to Detect Rare Neuroendocrine Tumors
The U.S. Food and Drug Administration (FDA) today approved Netspot, the first kit for the preparation of Ga-68 dotatate injection, a radioactive diagnostic agent for positron-emission tomography (PET) imaging. This radioactive probe will help locate tumors in adult and pediatric patients with...
FDA Approves New Diagnostic Imaging Agent to Detect Recurrent Prostate Cancer
On May 27, the U.S. Food and Drug Administration (FDA) approved fluciclovine F-18 (Axumin), a radioactive diagnostic agent for injection. Fluciclovine F-18 is indicated for positron-emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated...
In Memoriam
The ASCO Post remembers the following specialists in oncology who passed away in 2015–2016. Please write to editor@ASCOPost.com to recognize and pay tribute to others in a future issue. Mark R. Green, MD January 3, 1945–February 23, 2015 “Few people have impacted cancer clinical research in the...
Eribulin Improves Overall Survival vs Dacarbazine in Previously Treated Advanced Liposarcoma or Leiomyosarcoma
In a phase III trial reported in The Lancet, Patrick Schöffski, MD, of University Hospitals Leuven, Leuven Cancer Institute, Belgium, and colleagues found that eribulin (Halaven) improved overall survival vs dacarbazine in patients with advanced or metastatic soft-tissue sarcoma who had received...
FDA Approves Lenvatinib in Combination With Everolimus in Advanced Renal Cell Carcinoma
On May 13, 2016, the U.S. Food and Drug Administration (FDA) approved lenvatinib capsules (Lenvima) in combination with everolimus (Afinitor) for the treatment of advanced renal cell carcinoma following one prior antiangiogenic therapy. Lenvatinib was first approved in 2015 for the treatment of...
Atezolizumab in Previously Treated Advanced Urothelial Carcinoma
The recent study by Rosenberg et al in The Lancet—summarized in this issue of The ASCO Post—is a very important paper in the field of bladder cancer therapy.1 It is the first phase II trial in metastatic transitional cell carcinoma that demonstrates the single-agent activity of the...
ODAC Advises the FDA to Wait for Phase III Results for Rociletinib in Non–Small Cell Lung Cancer
The U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) met April 12 to consider a New Drug Application by Clovis Oncology for rociletinib, an investigational therapy for epidermal growth factor receptor (EGFR)-mutated non–small cell lung cancer (NSCLC) in patients...
FDA Maintains Ongoing Efforts to Expedite Drug Approvals
The U.S. Food and Drug Administration (FDA) is continuing its efforts to expedite oncology-hematology drug approvals. As of May 15, 2016, FDA has approved the following agents since January of this year. Lenvatinib (Lenvima), in combination with everolimus (Afinitor), for the treatment of advanced ...
Venetoclax for Previously Treated Chronic Lymphocytic Leukemia With 17p Deletion
On April 11, 2016, venetoclax (Venclexta) was approved for treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by a U.S. Food and Drug Administration (FDA)-approved test, who have received at least one prior therapy.1,2 The accelerated approval was based...
FDA Grants Selumetinib Orphan Drug Designation for Adjuvant Treatment of Differentiated Thyroid Cancer
Earlier this month, AstraZeneca announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation for the investigational MEK1/2 inhibitor selumetinib for adjuvant treatment of patients with stage III or IV differentiated thyroid cancer. Selumetinib inhibits the MEK...
Expect Questions About the New Rule on E-Cigarettes
“There are a lot of myths around new and emerging tobacco products, including e-cigarettes, and unfortunately, the biggest misconception is that these products are fairly or entirely harmless and risk-free,” Alexander V. Prokhorov, MD, PhD, said in an interview with The ASCO Post about a new...
New FDA Rule Prohibits Sale of E-Cigarettes to Anyone Under Age 18 and Requires Warning Labels
A new rule extending U.S. Food and Drug Administration (FDA) oversight to all tobacco products, including electronic cigarettes (e-cigarettes), and banning the sale of these products to anyone under the age of 181 was hailed as a major advanced by many leaders of medical and health organizations....
Cabozantinib in Advanced Renal Cell 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. On April 25, 2016, a tablet formulation of cabozantinib...
Breast Cancer Research Foundation: Revitalizing Academic Research in Breast Cancer Through Drug Research Collaborative
When Evelyn H. Lauder was diagnosed with breast cancer in 1989, she became a vocal spokesperson for women’s health, and in 1993, along with Larry Norton, MD, now Deputy Physician-in-Chief for Breast Cancer Programs and Medical Director of the Evelyn H. Lauder Breast Center at Memorial Sloan...
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®): 2016 Guidelines
In 1996, the National Comprehensive Cancer Network (NCCN®) published its first set of Clinical Practice Guidelines in Oncology® (NCCN Guidelines®), covering eight tumor types. The NCCN Guidelines® are now published for more than 60 tumor types and topics. Some of the key updates for 2016 were...
FDA Approves Nivolumab for Heavily Pretreated Classical Hodgkin Lymphoma
On May 17, 2016, the U.S. Food and Drug Administration (FDA) granted accelerated approval to the programmed cell death protein 1 (PD‑1) inhibitor, nivolumab (Opdivo), for the treatment of patients with classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem...
How Immunotherapy Is Revolutionizing Cancer Care
More than 100 years after William B. Coley, MD, used bacterial toxins to goad the immune system into recognizing cancer cells as foreign to the body and mount an immune response to go after and kill them, the recognition of immunotherapy as a powerful anticancer therapy is finally being...
Maximizing Cancer Cure: How Do We Get There?
Is cancer really “curable,” and if so, how? For a “Cancer Dialogue” held during the 2016 American Association of Cancer Research (AACR) Annual Meeting, half a dozen stellar participants from the research, industry, regulatory, and advocacy communities convened to debate the topic. The ASCO Post was ...
The Arrival of Generic Imatinib Into the U.S. Market: An Educational Event
Imatinib mesylate (Gleevec), a Bcr-Abl tyrosine kinase inhibitor, is approved therapy for chronic myeloid leukemia (CML) in the United States. Imatinib is a miraculous drug that results in a normal functional lifespan in most patients with CML who can afford and comply with the treatment and who ...
ASCO 2016: Autologous Stem Cell Transplant Remains Relevant in Multiple Myeloma, Even in Era of Novel Agents
Early findings from a phase III clinical trial (EMN02/HO95 MM) showed that patients with multiple myeloma who received an autologous stem cell transplant survived longer without disease progression than those who received only chemotherapy using novel agents. This is the largest study reported to...
FDA Approves Atezolizumab for Advanced Urothelial Carcinoma
The U.S. Food and Drug Administration (FDA) today granted accelerated approval to atezolizumab (Tecentriq) for the treatment of urothelial carcinoma, the most common type of bladder cancer. This is the first programmed cell death protein 1/programmed death ligand 1 (PD-1/PD-L1) inhibitor to be...
FDA Grants Accelerated Approval to Nivolumab in Classical Hodgkin Lymphoma
On May 17, 2016, the U.S. Food and Drug Administration (FDA) granted accelerated approval to nivolumab (Opdivo; Bristol-Myers Squibb) for the treatment of patients with classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and...
Addition of Ixazomib to Lenalidomide/Dexamethasone Improves Progression-Free Survival in Relapsed/Refractory Multiple Myeloma
Moreau et al found that adding the oral proteasome inhibitor ixazomib (Ninlaro) to lenalidomide (Revlimid) and dexamethasone significantly prolonged progression-free survival among patients with relapsed, refractory, or relapsed and refractory multiple myeloma. They reported the findings from the...
FDA Approves Lenvatinib in Combination With Everolimus in Advanced Renal Cell Carcinoma
On May 13, 2016, the U.S. Food and Drug Administration (FDA) approved lenvatinib capsules (Lenvima), in combination with everolimus (Afinitor) for the treatment of advanced renal cell carcinoma following one prior antiangiogenic therapy. Lenvatinib was first approved in 2015 for the treatment...
Combining Two FDA-Approved Diagnostic Tests Increased Detection of High-Grade Cervicovaginal Lesions
Cytopathology researchers at Houston Methodist Hospital recently found that combining two diagnostic tests—the Papanicolau (Pap) and high-risk human papillomavirus (hrHPV)—dramatically decreased the chance of missing tumors and high-grade lesions by sevenfold. Zhou et al published...
FDA Grants Selumetinib Orphan Drug Designation for Adjuvant Treatment of Differentiated Thyroid Cancer
AstraZeneca announced on May 12 that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation for the investigational MEK 1/2 inhibitor selumetinib (AZD6244, ARRY-142886) for adjuvant treatment of patients with stage III or IV differentiated thyroid cancer. Differentiated...
FDA Launches First Campaign Focused on Dangers of Smokeless Tobacco Among Rural Teens
The U.S. Food and Drug Administration (FDA) has announced it is expanding its award-winning “The Real Cost” campaign to educate rural white male teenagers about the negative health consequences associated with smokeless tobacco use. For the first time, messages on the dangers of smokeless tobacco...
Breakthrough Therapy Efforts Result in Unprecedented Success
Friends of Cancer Research (Friends) and the U.S. Food and Drug Administration (FDA) have been working together for many years on an idea known as breakthrough therapy, and it has produced results beyond anyone’s hopes. Said Ellen Sigal, PhD, Friends Chair and Founder, “When we were first talking...
Defibrotide Sodium for Hepatic Veno-occlusive Disease After HSCT
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 30, 2016, defibrotide sodium (Defitelio) was approved for...
Breaking Down Dogma With the Outgoing President of SGO
At the 2016 Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer, The ASCO Post sat down with the SGO’s outgoing President, Robert L. Coleman, MD, and discussed the revolutionary potential of blood biomarkers, why enhanced recovery after surgery protocols is a significant...
FDA Approves Cabozantinib in Patients With Renal Cell Carcinoma Who Have Received Prior Antiangiogenic Therapy
On April 25, 2016, the U.S. Food and Drug Administration (FDA) approved cabozantinib (Cabometyx) tablets for the treatment of advanced renal cell carcinoma in patients who have received prior antiangiogenic therapy. Cabozantinib is a dual tyrosine kinase inhibitor of MET and VEGFR2. The capsule...
FDA Grants Priority Review for BLA for Olaratumab in Advanced Soft-Tissue Sarcoma
Eli Lilly and Company announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review for the biologics license application (BLA) for olaratumab, a platelet-derived growth factor receptor alpha (PDGFRα) antagonist, in combination with doxorubicin, for the...
FDA Grants sBLA for Blinatumomab in Pediatric Patients With Ph–Negative Relapsed/Refractory B-Cell Precursor ALL
Amgen announced on May 3 that the U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for blinatumomab (Blincyto) to include new data supporting the treatment of pediatric and adolescent patients with Philadelphia...
FDA Approves Cabozantinib in Patients With Renal Cell Carcinoma Who Have Received Prior Antiangiogenic Therapy
On April 25, 2016, the U.S. Food and Drug Administration (FDA) approved cabozantinib (Cabometyx) tablets for the treatment of advanced renal cell carcinoma in patients who have received prior antiangiogenic therapy. Cabozantinib is a dual tyrosine kinase inhibitor of MET and VEGFR2. The...
FDA Grants Breakthrough Designation to Nivolumab in Squamous Cell Carcinoma of the Head and Neck
On April 25, 2016, the U.S. Food and Drug Administration (FDA) granted breakthrough therapy designation to the anti–programmed death 1 antibody nivolumab (Opdivo) for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck that previously received...
Friends of Cancer Research Encourages FDA to Modernize and Consolidate
“In order to take advantage of today’s advancements in science, drug development, and patient treatment, the U.S. Food and Drug Administration’s (FDA’s) structure needs reorganization to focus its resources and ensure the best outcomes for patients. Friends of Cancer Research (Friends) proposes...
