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Showing 2501 - 2550FDA Approves Ofatumumab in Combination With Fludarabine and Cyclophosphamide for Relapsed CLL
Genmab A/S announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application for the use of ofatumumab (Arzerra) in combination with fludarabine and cyclophosphamide for the treatment of patients with relapsed chronic lymphocytic leukemia...
Researchers Question Process for Reviewing Coverage of 'Off-Label' Cancer Drug Use
A group of University of North Carolina (UNC) Lineberger Comprehensive Cancer Center researchers is calling for an overhaul of the process that determines which cancer drugs used off-label—or beyond their approved use—are reimbursed by federally funded health insurance in the United...
FDA Accepts New Drug Application, Grants Priority Review of Rucaparib for the Treatment of Advanced BRCA-Mutant Ovarian Cancer
The U.S. Food and Drug Administration (FDA) has accepted Clovis Oncology’s New Drug Application (NDA) for accelerated approval of rucaparib and granted Priority Review status to the application with a Prescription Drug User Fee Act date of February 23, 2017. Rucaparib is an...
Former Clinical Director at the NCI, Gregory A. Curt, MD, Dies
In MemoriamGregory A. Curt, MD1952 – 2016 Gregory A. Curt, MD, Former Clinical Director at the National Cancer Institute (NCI) and nationally regarded expert on translational oncology died on July 31, 2016. He was 64 years old. Dr. Curt received his MD with distinction in research from the...
FDA Approves Extended-Release Granisetron Injection for the Prevention of Chemotherapy-Induced Nausea and Vomiting
The U.S. Food and Drug Administration (FDA) has approved an extended-release version of granisetron (Sustol) for the prevention of chemotherapy-induced nausea and vomiting, according to a news release by Heron Therapeutics, the drug’s manufacturer. Granisetron is an extended-release, injectable...
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 ...
GADOLIN and the Perplexing Role of Obinutuzumab in the Treatment of B-Cell Malignancies
After several dose-finding phase I and II studies in a variety of B-cell malignancies, the potential clinical role of the newer anti-CD20 monoclonal antibody obinutuzumab (Gazyva) remained unclear. These early trials tested low and high doses as well as weekly and every-3-week schedules of...
Scalp Cooling for Chemotherapy-Induced Alopecia Becoming Mainstream
Hair loss can be a devastating side effect of chemotherapy, but the recent U.S. Food and Drug Administration (FDA) approval of the DigniCap Cooling System and the growing acceptance of scalp-cooling methods in the United States may improve the quality of life for many patients receiving...
ASCO Guideline Addresses Controversial Areas in Adjuvant Therapy for Breast Cancer
ASCO has published an adaptation of the 2015 Cancer Care Ontario (CCO) clinical practice guideline on adjuvant chemotherapy for early-stage breast cancer.1 There were several areas of controversy that the guideline attempts to address. Should Anthracyclines Be Standard of Care? The guideline...
How the Oncology Center of Excellence Plans to Foster Collaboration Among Researchers to Advance Cancer Treatment
On June 29, 2016, Robert M. Califf, MD, MACC, the Commissioner of the U.S. Food and Drug Administration (FDA), announced the selection of Richard Pazdur, MD, FACP, as Acting Director of the FDA’s newly created Oncology Center of Excellence. The center was created in response to the overarching...
Inotuzumab Ozogamicin Shows Clear Benefit in Acute Lymphoblastic Leukemia
In patients with relapsed/refractory acute lymphoblastic leukemia (ALL), the antibody-drug conjugate inotuzumab ozogamicin produced significantly more complete remissions and was a better bridge to transplant than treatment by physician’s choice, according to the final results of a phase III trial...
FDA Grants Orphan Drug Designation to CD4CAR for the Treatment of Peripheral T-Cell Lymphoma
iCell Gene Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation for its chimeric antigen receptor engineered T-cells directed against the target protein CD4 (CD4CAR) for the treatment of peripheral T-cell lymphoma (PTCL). William Tse, MD,...
FDA Approves Extended-Release Granisetron Injection for the Prevention of Chemotherapy-Induced Nausea and Vomiting
Heron Therapeutics, Inc, announced on August 10, 2016, that the U.S. Food and Drug Administration (FDA) has approved granisetron (Sustol) extended-release injection. Granisetron is a serotonin-3 (5-HT3) receptor antagonist indicated in combination with other antiemetics in adults for the prevention ...
Multiple Means to Realize the Benefits of Colorectal Cancer Screening
In an updated recommendation statement, the U.S. Preventive Services Task Force (USPSTF) continues to strongly recommend screening for colorectal cancer for asymptomatic adults aged 50 through 75; but rather than emphasize specific screening strategies, it notes there are multiple screening...
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...
Reference Laboratory Identifies Change in Pattern of Breast Cancer HER2 Fluorescence in Situ Hybridization Results
The most recent (2013) ASCO/College of American Pathologists (AC) guidelines for HER2 testing resulted in different rates of HER2 positivity compared with the use of the U.S. Food and Drug Administration (FDA) or 2007 AC guidelines, according to a study reported in the Journal of Clinical Oncology...
FDA Approves Sofosbuvir/Velpatasvir for Treatment of Chronic Hepatitis C Virus Infection
The U.S. Food and Drug Administration (FDA) approved Epclusa (sofosbuvir at 400 mg/velpatasvir at 100 mg) on June 28, 2016, to treat adult patients with chronic hepatitis C virus both with and without cirrhosis. For patients with moderate to severe cirrhosis (decompensated cirrhosis),...
FDA Approves First HPV Test for Use With SurePath Preservative Fluid
On July 7, 2016, the U.S. Food and Drug Administration (FDA) approved the Roche cobas HPV Test as the first test for human papillomavirus (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...
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; clinicaltrials.gov identifier NCT02535364) in adult patients with relapsed or refractory B-cell...
Ribociclib Receives FDA Breakthrough Therapy Designation for Treatment of Hormone Receptor–Positive, HER2-Negative Advanced Breast Cancer
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to ribociclib in combination with letrozole for the treatment of hormone receptor–positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. Ribociclib...
ASCO and Friends of Cancer Research Launch Initiative to Modernize Eligibility Criteria for Clinical Trials
The dismal accrual rates in cancer clinical trials are well known: Just 3% to 5% of adults with cancer enroll in clinical trials.1 The reasons patients are reluctant to participate in clinical trials are equally well known: fear of reduced quality of life, concern about receiving a placebo, and...
FDA Grants Breakthrough Therapy Designation for Daratumumab in Combination With Standard of Care for Multiple Myeloma
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to the immunotherapy daratumumab (Darzalex) in combination with lenalidomide (Revlimid) and dexamethasone, or bortezomib (Velcade) and dexamethasone, for the treatment of patients with multiple myeloma who have ...
The National Cancer Moonshot Lifts Off
Just 6 months after President Barack Obama announced the establishment of a National Cancer Moonshot Initiative to accelerate the pace of research discoveries, improve patient access and care, and encourage data-sharing, dozens of new initiatives to accomplish those and other goals were rolled out...
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. When finalized, they will provide a flexible and streamlined approach to the oversight of tests that detect medically important differences in a person’s...
As Low-Dose CT Screening Moves Into the Clinic, Implementation Issues Move Up on the Agenda
Low-dose computed tomography (CT) screening for lung cancer in high-risk groups is moving into the clinic in the wake of its approval by the U.S. Centers for Medicaid & Medicare Services. That does not mean, however, the discussion is over. As low-dose CT moves from research to everyday...
Road 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...
