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Showing 2501 - 2550Road to Successful Use of Real-World Evidence for Drug Development Is Long and Rocky
Friends of Cancer Research (Friends) has been a leader in the push for better and faster cancer drug development. Now it is tackling the use of real-world evidence in clinical trials. This is the report of a meeting on the subject that took place on June 16 in Washington, DC.1 Real-world evidence...
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...
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....
Results of Two Practice-Changing Breast Cancer Trials Upheld
Results of two pivotal breast cancer trials reported at the 2016 ASCO Annual Meeting confirmed the practice-changing findings that resulted from earlier findings. PALOMA-2 The phase III PALOMA-2 trial confirmed results from the smaller, open-label phase II PALOMA-1 trial that led to the U.S. Food...
Juno Therapeutics to Resume JCAR015 Phase II ROCKET Trial After FDA Clinical Hold
Juno Therapeutics, Inc, announced on July 12, 2016, that the U.S. Food and Drug Administration (FDA) has removed the clinical hold on the phase II clinical trial of JCAR015 (known as the ROCKET trial) in adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL). Under the ...
FDA Approves First HPV Test for Use With SurePath Preservative Fluid
On July 7, the U.S. Food and Drug Administration (FDA) approved the Roche cobas HPV Test as the first test for Human Papilloma Virus (HPV) that can be used with cervical cells obtained for a Papanicolau (Pap) test and collected in SurePath Preservative Fluid. The FDA approves HPV tests to be used...
FDA Advances Precision Medicine Initiative by Issuing Draft Guidances on Next-Generation Sequencing–Based Tests
In support of the President’s Precision Medicine Initiative, on July 6, the U.S. Food and Drug Administration (FDA) issued two draft guidances that, when finalized, will provide a flexible and streamlined approach to the oversight of tests that detect medically important differences in a...
Richard Pazdur, MD, Named Acting Director of FDA’s Oncology Center of Excellence
U.S. Food and Drug Administration (FDA) Commissioner Robert Califf, MD, issued the following statement June 29, 2016, regarding the appointment of Richard Pazdur, MD, as the Acting Director of the FDA Oncology Center of Excellence. Dr. Pazdur is currently Director of the Office of Oncology...
ASCO Applauds Selection of Richard Pazdur, MD, to Lead New FDA Oncology Center of Excellence
Daniel F. Hayes, MD, ASCO President, issued the following statement on June 29, 2016: “ASCO commends FDA Commissioner Dr. Robert Califf for his selection of Dr. Richard Pazdur to lead the agency’s new Oncology Center of Excellence. In his nearly 20 years with the FDA, Dr. Pazdur has worked...
Combination of Nivolumab and Ipilimumab Moves Forward in NSCLC
How best to combine new immunotherapies is a burning question in oncology. A new study in the CheckMate series suggests that nivolumab (Opdivo) and ipilimumab (Yervoy) can be safely and effectively combined as first-line treatment of advanced non–small cell lung cancer (NSCLC),1 but further study...
Richard Pazdur, MD, Named Acting Director of the FDA Oncology Center of Excellence
U.S. Food and Drug Administration (FDA) Commissioner Robert Califf, MD, issued the following statement today regarding the appointment of the Acting Director of the FDA Oncology Center of Excellence. “The FDA is honored to be an integral part of the Vice President’s National Cancer...
FDA Approves Sofosbuvir/Velpatasvir for Treatment of Chronic Hepatitis C Virus Infection
On June 28, the U.S. Food and Drug Administration (FDA) approved a fixed-dose combination of sofosbuvir, 400 mg, plus velpatasvir, 100 mg (Epclusa) to treat adult patients with chronic hepatitis C virus (HCV) either with or without cirrhosis. For patients with moderate to severe cirrhosis...
Nivolumab Receives FDA Breakthrough Therapy Designation for Advanced/Metastatic Urothelial Carcinoma
Bristol-Myers Squibb Company announced June 27 that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to nivolumab (Opdivo) for the potential indication of unresectable locally advanced or metastatic urothelial carcinoma that has progressed on or after a...
Initiative to Modernize Eligibility Criteria for Clinical Trials Launched
ASCO and Friends of Cancer Research (Friends) have launched a collaborative effort to modernize eligibility criteria to promote greater patient participation in cancer clinical trials. Although it is important for defining the population under study and ensuring patient safety, overly strict...
A Conquer Cancer Foundation Award Helps to Launch a Pioneering Study in Liposarcoma
Mark A. Dickson, MD, has been fascinated by science and medicine since he was in high school. After graduating magna cum laude from Harvard University in 1999, Dr. Dickson pursued a medical degree from the College of Physicians and Surgeons at Columbia University in New York. Once he decided on a...
Treatment Update in Gastric, Pancreatic, and Colorectal Cancers
Although new gastrointestinal cancers are on the rise, advancements in their treatment, as well as the upcoming results of perioperative trials, could prove to be “clinical practice game-changers,” declared Thomas J. George, Jr, MD, FACP, at the 2016 Community Oncology Conference in Orlando,...
‘Liquid Biopsy’ Stacks Up Well to Tissue Biopsy in Detecting Tumor-Specific Mutations
So-called liquid biopsy identified cancer mutations in 85% of all advanced tumors, in the largest-ever evaluation of circulating tumor DNA (ctDNA) in the blood.1 In 49% of the cases, these biomarkers were associated with an approved targeted drug, Philip C. Mack, PhD, reported at the 2016 ASCO...
Trastuzumab Biosimilar Shows Efficacy and Safety Comparable to Reference Product in Phase III HERITAGE Trial
A new biosimilar version of the monoclonal antibody trastuzumab (Herceptin) is getting close to the finish line in the race to develop biosimilars in oncology. The new antibody, MYL-1401O, demonstrated comparable efficacy and safety compared with trastuzumab as front-line treatment of women with...
FDA Approves EGFR Mutation–Detecting Blood Test for NSCLC
The U.S. Food and Drug Administration (FDA) recently 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...
FDA Approves New Diagnostic Imaging Agent to Detect Rare Neuroendocrine Tumors
The U.S. Food and Drug Administration (FDA) has 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...
Clinical Trials Actively Recruiting Patients With Liver Cancer
Pilot Study Title: Pilot Study of Hepatic Arterial Infusion Therapy in Patients With Unresectable or Borderline Resectable Intrahepatic Cholangiocarcinoma Study Type: Interventional/nonrandomized/parallel assignment Study Sponsor and Collaborators: Washington University School of Medicine Purpose: ...
SIRIUS Trial Heralds a New Era of Promise in Treating Resistant Myeloma
Multiple myeloma cells uniformly overexpress CD38.1 Daratumumab (Darzalex), a CD38-targeting human IgG1 kappa monoclonal antibody, has been evaluated in a series of phase I/II trials involving patients with relapsed or relapsed and refractory myeloma who have received at least two or more prior...
Prostate Cancer: Opinions Vary on Gleason Scores and Surgery
Diagnosis and treatment of prostate cancer have been the source of heated debate for decades, most of which has centered on the clinical value of the prostate-specific antigen (PSA) test. In 2012, the U.S Preventive Services Task Force (USPSTF) gave the PSA test a D grade, which discourages many...
PALOMA-3 Trial in HER2-Negative Metastatic Breast Cancer: Challenge of Moving Beyond Estrogen Receptor Positivity
Hormone receptor–positive breast cancer represents the largest therapeutic subgroup of the disease. The development of endocrine therapies has shaped the treatment paradigm for both advanced- and early-stage disease for decades.1 Still, despite their significant impact, advanced breast cancer...
Prolonged 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...
