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Showing 2151 - 2200FDA Awards Grants for Clinical Trials to Stimulate Product Development for Rare Diseases
THE U.S. FOOD and Drug Administration (FDA) has awarded numerous new clinical trial research grants, totaling more than $22 million over the next 4 years, to boost the development of products for patients with rare diseases. These new grants were awarded to principal investigators from academia and ...
Carfilzomib May Be a Strong Candidate for Salvage Therapy in Relapsed/Refractory Multiple Myeloma—but Questions Remain
WITH THE INCLUSION of proteasome inhibitors and immunomodulatory agents first into salvage and then as components of first-line, consolidation, and maintenance regimens, response rates, depth of response, and median progression-free and overall survival have all improved for patients suffering...
For HPV Vaccine to Have Optimal Impact, ‘Provider Hesitancy’ Must Be Overcome
Honoring National Cancer Institute researchers Douglas R. Lowy, MD, and John T. Schiller, PhD, with the Lasker-DeBakey Clinical Medical Research Award for advances in technology that enabled the development of human papillomavirus (HPV) vaccines to prevent cervical cancer and other tumors caused by ...
FDA Conducts Global Operation to Protect Consumers From Potentially Dangerous Prescription Drugs Sold Online
THE U.S. FOOD AND DRUG ADMINISTRATION (FDA), in partnership with international regulatory and law enforcement agencies, recently took action against more than 500 websites that illegally sell potentially dangerous, unapproved versions of prescription medicines, including opioids, antibiotics, and...
Second-Line Pembrolizumab Extends Survival in Urothelial Cancer
PEMBROLIZUMAB (KEYTRUDA) extended survival by about 3 months in patients with advanced urothelial cancer whose disease progressed on platinum-based chemotherapy vs investigator’s choice of therapy, according to the mature results of the KEYNOTE-045 trial presented at the European Society for...
FDA Approves CAR T-Cell Therapy to Treat Adults With Certain Types of Large B-Cell Lymphoma
On October 18, the U.S. Food and Drug Administration (FDA) approved axicabtagene ciloleucel (Yescarta), a cell-based gene therapy, to treat adult patients with certain types of large B-cell lymphoma who have not responded to or who have relapsed after at least two other kinds of treatment....
FDA Grants Priority Review for Cabozantinib in Previously Untreated Advanced Renal Cell Carcinoma
On October 16, the U.S. Food and Drug Administration (FDA) determined the supplemental New Drug Application (sNDA) for cabozantinib (Cabometyx) for patients with previously untreated advanced renal cell carcinoma (RCC) to be sufficiently complete to permit a substantive review. The FDA granted...
IASLC 2017: Lorlatinib in ALK-Positive and ROS1-Positive Advanced Non–Small Cell Lung Cancer
At the International Association for the Study of Lung Cancer (IASLC) 18th World Conference on Lung Cancer in Yokohama, Japan, Pfizer announced full results from the phase II clinical trial of the investigational, next-generation tyrosine kinase inhibitor lorlatinib. The agent exhibited clinically...
FDA Clears 7T Magnetic Resonance Imaging Device
On October 12, the U.S. Food and Drug Administration (FDA) cleared the first 7-Tesla (7T) magnetic resonance imaging (MRI) device, more than doubling the static magnetic field strength available for use in the United States. The Magnetom Terra is the first 7T MRI system cleared for clinical use in...
FDA Grants Priority Review for Abemaciclib as Initial Treatment of Advanced Breast Cancer
On October 12, Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) granted Priority Review designation to its New Drug Application (NDA) for abemaciclib (Verzenio), a cyclin-dependent kinase (CDK) 4/6 inhibitor. MONARCH 3 The NDA was based upon the positive interim...
Osimertinib Granted Breakthrough Therapy Designation for First-Line Treatment of EGFR Mutation–Positive NSCLC
On October 9, AstraZeneca announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for osimertinib (Tagrisso) for the first-line treatment of patients with metastatic epidermal growth factor receptor (EGFR) mutation–positive non–small cell lung ...
Brentuximab Vedotin Granted FDA Breakthrough Therapy Designation in Front-Line Advanced Hodgkin Lymphoma
On October 2, Seattle Genetics, Inc, announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to brentuximab vedotin (Adcetris) in combination with chemotherapy for the front-line treatment of patients with advanced classical Hodgkin lymphoma. The positive ...
Nivolumab in MSI-H or dMMR Metastatic Colorectal Cancer
ON JULY 31, 2017, nivolumab (Opdivo) was granted accelerated approval for treatment of patients 12 years and older with DNA mismatch repair–deficient (dMMR) and microsatellite instability– high (MSI-H) metastatic colorectal cancer progressing following treatment with a fluoropyrimidine,...
Immunotherapy for Metastatic Mismatch Repair–Deficient Colorectal Cancer: Game-Changer for Small Group of Patients
PATIENTS WITH DNA mismatch repair–deficient (dMMR) metastatic colorectal cancer display a high level of microsatellite instability (MSI-H)1 and demonstrate poor chemosensitivity and shorter overall survival than patients with mismatch repair–proficient (pMMR) metastatic metastatic colorectal...
FDA Grants Accelerated Approval to Nivolumab for Hepatocellular Carcinoma Previously Treated With Sorafenib
ON SEPTEMBER 22, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to nivolumab (Opdivo) for the treatment of hepatocellular carcinoma in patients who have been previously treated with sorafenib (Nexavar). CheckMate 040 APPROVAL WAS BASED on a 154-patient subgroup of ...
Strong Showing for Rucaparib Maintenance Therapy for Platinum-Sensitive Ovarian Cancer
EVIDENCE CONTINUES to mount for the benefits of poly (ADP-ribose) polymerase (PARP) inhibition in ovarian cancer. Rucaparib (Rubraca) maintenance therapy after response to platinum-containing therapy significantly improved progression-free survival in patients with recurrent ovarian cancer compared ...
FDA Approves Copanlisib for Relapsed Follicular Lymphoma
THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) has granted accelerated approval to copanlisib (Aliqopa) for the treatment of adults with relapsed follicular lymphoma who have received at least two prior systemic therapies. Copanlisib is a kinase inhibitor that works by blocking several enzymes that...
FDA Accepts sNDA for Lenvatinib for the Treatment of Hepatocellular Carcinoma
On September 26, Eisai Inc announced the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) for lenvatinib (Lenvima) for potential use in the first-line treatment of patients with hepatocellular carcinoma. “Patients with...
Can We Have a Successful Vaccine Against Cancer?
EARLY IN our careers, few of us imagined that a vaccine could one day prevent cancer. Now, there is a vaccine that keeps the risks from human papillomavirus (HPV) at bay, and yet universal adoption of the HPV vaccine has been incomplete. As a result of misinformation about the vaccine—and its...
FDA Conducts Global Operation to Protect Consumers From Potentially Dangerous Prescription Drugs Sold Online
The U.S. Food and Drug Administration (FDA), in partnership with international regulatory and law enforcement agencies, recently took action against more than 500 websites that illegally sell potentially dangerous, unapproved versions of prescription medicines, including opioids, antibiotics, and...
FDA Grants Priority Review for Pertuzumab for Adjuvant Treatment of HER2-Positive Early Breast Cancer
On September 29, Roche announced the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application and granted Priority Review for pertuzumab (Perjeta), in combination with trastuzumab (Herceptin) and chemotherapy, for adjuvant treatment of...
FDA Grants Accelerated Approval to Pembrolizumab for Advanced Gastric Cancer
On September 22, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) for patients with recurrent locally advanced or metastatic, gastric or gastroesophageal junction adenocarcinoma whose tumors express programmed cell death ligand 1 (PD-L1) as ...
Avelumab in Locally Advanced or Metastatic Urothelial Carcinoma
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On May 9, 2017, avelumab (Bavencio) was granted...
Combination of Rituximab and Hyaluronidase Human for Subcutaneous Use in Lymphoma and Leukemia
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On June 22, 2017, the combination of rituximab (Rituxan)...
FDA Expands Approval of Ipilimumab to Pediatric Patients 12 Years and Older
On July 24, the U.S. Food and Drug Administration (FDA) expanded the indication for ipilimumab (Yervoy) injection for intravenous use now to include the treatment of unresectable or metastatic melanoma in pediatric patients 12 years of age and older. Ipilimumab was evaluated in 2 trials of...
FDA Approves New CDK4/6 Inhibitor for Certain Advanced or Metastatic Breast Cancers
The U.S. Food and Drug Administration today approved abemaciclib (Verzenio) to treat adult patients who have hormone receptor–positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer that has progressed after endocrine therapy. Abemaciclib is...
FDA Grants Accelerated Approval to Pembrolizumab for Advanced Gastric Cancer
On September 22, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) for patients with recurrent locally advanced or metastatic, gastric or gastroesophageal junction adenocarcinoma whose tumors express programmed cell death ligand 1 (PD-L1) as...
FDA Grants Accelerated Approval to Nivolumab for Hepatocellular Carcinoma Previously Treated With Sorafenib
On September 22, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to nivolumab (Opdivo) for the treatment of hepatocellular carcinoma in patients who have been previously treated with sorafenib (Nexavar). CheckMate 040 Approval was based on a 154-patient subgroup of...
Tisagenlecleucel for B-Cell Acute Lymphoblastic Leukemia
On August 30, 2017, tisagenlecleucel (Kymriah) was granted regular approval for the treatment of patients up to age 25 years with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse.1,2 Tisagenlecleucel is the first chimeric antigen receptor (CAR)...
Inotuzumab Ozogamicin for Relapsed/Refractory B-Cell Precursor ALL
On August 17, 2017, inotuzumab ozogamicin (Besponsa) was approved for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).1,2 Supporting Efficacy Data APPROVAL WAS BASED on complete remission rates in the open-label phase III INO-VATE ALL...
FDA Recent Approvals Include First Oncology Biosimilar
ON SEPTEMBER 14, 2017, the U.S. Food and Drug Administration (FDA) approved bevacizumab-awwb (Mvasi) as a biosimilar to bevacizumab (Avastin) for the treatment of multiple types of cancer. Bevacizumab-awwb is the first biosimilar approved in the United States for the treatment of cancer....
Small Steps Forward in Brain Tumor Therapy
SOME RECENT ADVANCES in the treatment of brain tumors are promising, but others are less so, according to Jeffrey J. Olson, MD, Professor of Neurosurgery at Emory University, Atlanta. At the 2017 Debates and Didactics in Hematology and Oncology Conference, held in Sea Island, Georgia, and...
PD-L1 Inhibitor Consolidation Therapy for NSCLC: New Standard of Care?
THE PROGRAMMED CELL DEATH ligand 1 (PD-L1) inhibitor durvalumab (Imfinzi) improved progression-free survival by 11.2 months compared with placebo in patients with locally advanced, unresectable stage III non–small cell lung cancer (NSCLC) whose disease did not progress following standard treatment ...
Adoptive Cell Therapy—Act 1: The Beginning
ON AUGUST 30, 2017, the first genetically engineered T-cell therapy (tisagenlecleucel [Kymriah]) was approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia that is refractory or in second or...
AACR Releases 2017 Cancer Progress Report: Harnessing Research Discoveries to Save Lives
Federally funded research that provides a deep understanding of cancer is spurring advances against many types of the disease. With a strong bipartisan commitment from Congress to keep investment in biomedical research a national priority, we can accelerate our pace of progress and save more lives...
FDA Approves Copanlisib for Adults With Relapsed Follicular Lymphoma
Today, the U.S. Food and Drug Administration (FDA) granted accelerated approval to copanlisib (Aliqopa) for the treatment of adults with relapsed follicular lymphoma who have received at least two prior systemic therapies. “For patients with relapsed follicular lymphoma, the cancer often...
FDA Approves First Biosimilar for the Treatment of Cancer
The U.S. Food and Drug Administration today approved bevacizumab-awwb (Mvasi) as a biosimilar to bevacizumab (Avastin) for the treatment of multiple types of cancer. Bevacizumab-awwb is the first biosimilar approved in the U.S. for the treatment of cancer. “Bringing new biosimilars to...
FDA Pilot Program Aims to Encourage Students to Pursue STEM Careers
When I was in high school, I spent summers working as a restaurant dishwasher, grocery store stock boy, and gardener in northwest Indiana. The idea of spending those weeks learning about science and medicine would not have been an option for me at that time. Yet it is precisely those students who...
‘Substantial Improvements’ in the Treatment of Glioblastoma
NEWS ARTICLES about Senator John McCain’s diagnosis of glioblastoma accurately describe glioblastoma as aggressive and having a poor prognosis. But as Walter J. Curran, Jr, MD, pointed out in one of those reports, “substantial improvements in surgical approaches” have enabled more patients to...
Expert Point of View: David Maloney, MD, and Kenneth C. Anderson, MD
SIMILAR CELLULAR immunotherapies are currently being developed and tested by other National Cancer Institute–designated cancer centers, including Fred Hutchinson Cancer Research Center. David Maloney, MD, Medical Director of Cellular Immunotherapy at Fred Hutchinson and Medical Director of the...
FDA Approves First CAR T-Cell Therapy for Pediatric, Young Adult Patients With ALL
ON AUGUST 30, 2017, the U.S. Food and Drug Administration (FDA) approved tisagenlecleucel (Kymriah) for pediatric and young adult patients up to 25 years with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory to initial treatment or in second or later relapse. Tisagenlecleucel ...
FDA Approves Betrixaban for Prophylaxis of Venous Thromboembolism
ON JUNE 23, 2017, the U.S. Food and Drug Administration (FDA) approved betrixaban (Bevyxxa) for the prophylaxis of venous thromboembolism in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and...
Midostaurin in FLT3 Mutation–Positive Acute Myeloid Leukemia and Systemic Mastocytosis
ON APRIL 28, 2017, midostaurin (Rydapt) was approved for treatment of adults with newly diagnosed acute myeloid leukemia (AML) who have FLT3 mutation–positive disease, as detected by a U.S. Food and Drug Administration (FDA)-approved test, in combination with standard cytarabine and daunorubicin...
Pembrolizumab in Classical Hodgkin Lymphoma
On March 14, 2017, pembrolizumab (Keytruda) was granted accelerated approval for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma or those who have relapsed after three or more prior lines of therapy.1,2 Supporting Efficacy Data APPROVAL WAS BASED on...
Register for the Geriatric Oncology Workshop
On November 6, 2017, ASCO and the U.S. Food and Drug Administration (FDA) will hold a joint Geriatric Oncology Workshop aimed at improving the evidence base for treating the geriatric oncology population. While more than 60% of cancers in the United States occur in people aged 65 and older, the...
FDA Announces New Comprehensive Plan for Tobacco and Nicotine Regulation
Recently, the U.S. Food and Drug Administration (FDA) announced a new strategy to address tobacco-related disease and death. The agency seeks to develop a plan to reduce the nicotine levels in combustible cigarettes to nonaddictive levels. However, as part of the strategy, the FDA also announced it ...
Emerging Global Leaders in Biosimilar Development: Regulatory Guidance and Cost Impact
BIOLOGICS PLAY A KEY ROLE in cancer treatment and are the principal components of many therapeutic regimens.1 However, they require complex manufacturing processes, resulting in high cost and occasional shortages in supply, limiting the accessibility of cancer treatment for many patients, more so ...
Positioning Lu-177 Dotatate Therapy and 68-Ga Dotatate Scans in Management of Neuroendocrine Tumors
The results of the phase III NETTER-1 trial, recently published in The New England Journal of Medicine,1 have been met with great interest by clinicians who treat neuroendocrine tumors. In patients with advanced midgut lesions, treatment with the radiopharmaceutical lutetium Lu-177 dotatate...
Recent FDA Actions Include New Formulation, Expanded Indications for Oncology-Hematology Drug Products
The U.S. Food and Drug Administration (FDA) recently granted approval to olaparib tablets (Lynparza) as a maintenance therapy for ovarian cancer and to inotuzumab ozogamicin (Besponsa), for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)....
FDA Clears Mammography Device With Option for Patient-Assisted Compression
On September 1, the U.S. Food and Drug Administration (FDA) cleared the first 2D digital mammography system that allows patients to increase or decrease the amount of compression applied to their own breast before the mammogram x-ray is taken. “Regular mammograms are an important tool in...
