Search Results
Your search for ,Fda matches 3753 pages
Showing 1651 - 1700CAR T-Cell Therapy for DLBCL: At the Crossroads of Hype and Reality
In the 20-plus years I have spent in hematologic oncology, I have been fortunate to have a ringside seat to watch “game-changing” advances come into our field—all-trans retinoic acid for acute promyelocytic leukemia, tyrosine kinase inhibitors starting with imatinib for chronic myeloid leukemia,...
FDA Pipeline: Assay Approval, Breakthrough Designations for AI Technology and CLL, and More
In the past week, the U.S. Food and Drug Administration (FDA) approved a companion diagnostic assay, granted Breakthrough Device and Breakthrough Therapy designations, and extended the review period of a proposed treatment. The agency also published four draft guidances and one final guidance...
HHS Secretary Appoints Norman E. Sharpless, MD, as FDA Acting Commissioner
Today, the Secretary of Health and Human Services (HHS) Alex M. Azar II appointed Norman E. Sharpless, MD, to be the acting Commissioner of the U.S. Food and Drug Administration (FDA). He will be replacing the current FDA Commissioner, Scott Gottlieb, MD, who announced his resignation on March 5....
FDA Approves Trastuzumab-qyyp in HER2-Overexpressing Breast and Gastric Cancers
The U.S. Food and Drug Administration (FDA) has approved trastuzumab-qyyp (Trazimera), a biosimilar to trastuzumab (Herceptin), for the treatment of human epidermal growth factor receptor-2 (HER2)-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal...
Update on Newer Treatments in Non-Hodgkin Lymphomas
AS PART of The ASCO Post’s continued coverage of the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition, here is an update on several different studies on new therapeutics in non-Hodgkin lymphomas (NHLs), including follicular lymphoma, diffuse large B-cell lymphoma (DLBCL), ...
FDA Approves Trifluridine/Tipiracil for Recurrent, Metastatic Gastric and GEJ Adenocarcinoma
ON FEBRUARY 22, the U.S. Food and Drug Administration approved trifluridine/tipiracil tablets (Lonsurf)—a fixed combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor—for adult patients with metastatic gastric or gastroesophageal junction...
FDA Grants Accelerated Approval to Atezolizumab/Nab-Paclitaxel; Regular Approval Contingent on Confirmatory Trials
Today, the U.S. Food and Drug Administration (FDA) granted accelerated approval to atezolizumab (Tecentriq) plus nanoparticle albumin-bound (nab)-paclitaxel (Abraxane) for the treatment of adults with unresectable, locally advanced or metastatic, programmed cell death ligand 1 (PD-L1)-positive ...
Omega-3 Fatty Acids
The ASCO Post’s Integrative Oncology series is intended to facilitate the availability of evidence-based information on integrative and complementary therapies sometimes used by patients with cancer. Gary Deng, MD, PhD, and Jyothirmai Gubili, MS, explore the use of omega-3 fatty acids, which have...
Health-Care Fraud Prosecutions Are on the Rise
Prosecuting health-care fraud is a top priority for the U.S. Department of Justice (DOJ) and other federal government agencies.1,2 After all, the government earns a $6 return for every $1 that it spends on enforcement. In December 2018, the DOJ announced that it had obtained more than $2.5 billion...
Cabozantinib for Hepatocellular Carcinoma Previously Treated With Sorafenib
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 January 14, 2019, cabozantinib was approved for the...
FDA Commissioner Scott Gottlieb, MD, Resigns
On March 5, 2019, Scott Gottlieb, MD, announced his resignation as Commissioner of the U.S. Food and Drug Administration (FDA), a post he began in 2017. Dr. Gottlieb’s resignation will be effective next month. In a resignation letter to Alex M. Azar II, Secretary of Health and Human Services ...
FDA Pipeline: Updates on Treatments for Cervical Cancer, Myelofibrosis, Chemotherapy-Induced Nausea and Vomiting, and More
The FDA recently issued announcements on a Fast Track designation, a Priority Review, two supplemental new drug applications, an investigational new drug application, and a marketing clearance. The agency also released a safety communication on cancer-related surgery. Fast Track Designation for...
Pembrolizumab/Axitinib Combination Improves Outcomes vs Sunitinib in Kidney Cancer
The checkpoint inhibitor pembrolizumab plus the vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor axitinib significantly improved overall survival, progression-free survival, and objective response rates vs sunitinib as first-line therapy for clear cell metastatic renal cell...
FDA Approves Trastuzumab and Hyaluronidase-oysk for Subcutaneous Injection in Certain HER2-Positive Breast Cancers
On February 28, the U.S. Food and Drug Administration (FDA) approved trastuzumab and hyaluronidase-oysk (Herceptin Hylecta) for subcutaneous injection for the treatment of certain patients with HER2-positive early breast cancer (node-positive, or node-negative and estrogen receptor/progesterone...
AACR 2019: Diet May Influence Gut Microbiome and Response to Immunotherapy
Among patients with melanoma treated with anti–programmed cell death protein 1 (PD-1) immunotherapy, consumption of a high-fiber diet was associated with higher gut microbiome diversity and better response to treatment, according to data presented by Spencer et al at a presscast in advance of ...
AACR 2019: Liquid Biopsy–Based Test May Be Reliable in Identifying Treatment for Non–Small Cell Lung Cancer
The number of guideline-recommended biomarkers to be assessed in patients with newly diagnosed, metastatic non–small cell lung cancer (NSCLC) is increasing. These biomarkers include both predictive targets—including EGFR, ALK, ROS1, BRAF, RET, MET, and ERBB2—and prognostic...
FDA Approves Trifluridine/Tipiracil for Recurrent, Metastatic Gastric and GEJ Adenocarcinoma
On February 22, the U.S. Food and Drug Administration approved trifluridine/tipiracil tablets (Lonsurf)—a fixed combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor—for adult patients with metastatic gastric or...
Newly Discovered Mutation in BCL2 Protein Impacts Outcomes in Patients With Progressive CLL
INVESTIGATORS FROM Australia have identified a genetic mutation that causes resistance to the targeted drug venetoclax in patients with chronic lymphocytic leukemia (CLL), according to research presented at the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition1 and...
Conference Highlights From the 2018 American Society of Hematology Annual Meeting & Exposition
In sunny San Diego, the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition welcomed nearly 30,000 attendees who were eager to present, learn, network, and cheer the joint achievements of many researchers. The packed meeting was filled with important information from...
Pembrolizumab in Combination With Chemotherapy in First-Line Treatment of Metastatic Squamous NSCLC
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 October 30, 2018, pembrolizumab in combination with...
Update on FDA-Approved CAR T-Cell Products
AXICABTAGENE CILOLEUCEL (also known as CAR19) is an anti-CD19 chimeric antigen receptor (CAR) T-cell product approved by U.S. Food and Drug Administration to treat selected hematologic malignancies.1 To appreciate the clinical trial findings summarized here, from selected abstracts presented at the ...
Update on FDA-Approved CAR T-Cell Products
TISAGENLECLEUCEL IS an anti-CD19 chimeric antigen receptor (CAR) T-cell product approved by U.S. Food and Drug Administration to treat selected hematologic malignancies.1,2 To appreciate the clinical trial findings summarized here, from selected abstracts presented at the 2018 American Society of...
FDA Approves Caplacizumab-yhdp for Acquired Thrombotic Thrombocytopenic Purpura
ON FEBRUARY 6, 2019, the U.S. Food and Drug AdministrationFDA approved caplacizumab-yhdp (Cablivi) injection, in combination with plasma exchange and immunosuppressive therapy, for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP). “Patients with aTTP endure...
FDA Approves Split-Dosing Regimen of Therapy for Multiple Myeloma
ON FEBRUARY 12 , 2019, the U.S. Food and Drug Administration (FDA) approved a split-dosing regimen for daratumumab (Darzalex), providing health-care professionals and patients with multiple myeloma an option to split the first infusion over 2 consecutive days. Daratumumab is a CD38-directed...
Highlights From the 2018 ASH Annual Meeting & Exposition
TO ADD to our ongoing coverage of the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition, we bring readers of The ASCO Post these summaries of an assortment of interesting studies. They focus on novel therapies under investigation in the treatment of acute lymphoblastic...
FDA Pipeline: Priority Reviews in Solid Tumors and Lymphoma; Plus an sNDA in Acute Myeloid Leukemia
Over the past week, the U.S. Food and Drug Administration (FDA) granted multiple Priority Reviews and accepted a supplemental new drug application: Priority Review for Entrectinib in NTRK Fusion–Positive Solid Tumors and Metastatic, ROS1-Positive NSCLC This week, the FDA accepted new drug...
Steven A. Rosenberg, MD, PhD, Awarded the 2019 Szent-Györgyi Prize
The 2019 Szent-Györgyi Prize for Progress in Cancer Research will be awarded to Steven A. Rosenberg, MD, PhD, of the Center for Cancer Research (CCR) at the National Cancer Institute (NCI). The prize, awarded annually by the National Foundation for Cancer Research (NFCR), recognizes Dr. Rosenberg’s ...
Norman E. Sharpless, MD: From Director of a Comprehensive Cancer Center to Director of the NCI
GUEST EDITOR Dr. Abraham is the Director of the Breast Oncology Program at Taussig Cancer Institute, and Professor of Medicine, Lerner College of Medicine, Cleveland Clinic. In this installment of the Living a Full Life series of articles, guest editor Jame Abraham, MD, FACP, interviewed Norman E. ...
FDA Approves Adjuvant Pembrolizumab for Melanoma
On February 15, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for the adjuvant treatment of patients with melanoma with lymph node involvement following complete resection. Approval was based on the phase III EORTC1325/KEYNOTE-054 trial, a randomized, double-blind,...
CMS Proposes Medicare Coverage With Evidence Development for CAR T-Cell Therapy
Today, the Centers for Medicare & Medicaid Services (CMS) proposed coverage of U.S. Food and Drug Administration (FDA)–approved chimeric antigen receptor (CAR) T-cell therapy under its “coverage with evidence development” paradigm. Currently, there is no national...
FDA Pipeline: Priority Reviews in Renal Cell Carcinoma and Head and Neck Cancer
Over the past week, the U.S. Food and Drug Administration (FDA) granted multiple Priority Reviews: Pembrolizumab in Combination With Axitinib as First-Line Treatment for Advanced Renal Cell Carcinoma Today, the FDA accepted and granted Priority Review for a new supplemental biologics license...
Steven A. Rosenberg, MD, PhD, Awarded the 2019 Szent-Györgyi Prize
The 2019 Szent-Györgyi Prize for Progress in Cancer Research will be awarded to Steven A. Rosenberg, MD, PhD, of the Center for Cancer Research (CCR) at the National Cancer Institute (NCI). The prize, awarded annually by the National Foundation for Cancer Research (NFCR), recognizes Dr....
FDA Approves Daratumumab Split-Dosing Regimen
The U.S. Food and Drug Administration (FDA) has approved a split-dosing regimen for daratumumab (Darzalex), a CD38-directed antibody, providing health-care professionals and patients with multiple myeloma an option to split the first infusion over 2 consecutive days. The approval is based on...
Direct-to-Consumer Genetic Test on Hereditary Colorectal Cancer Syndrome Receives FDA Clearance
ON JANUARY 22, 2019, 23andMe received U.S. Food and Drug Administration (FDA) clearance for a genetic health risk report on the hereditary colorectal cancer syndrome MUTYH-associated polyposis. The clearance follows the FDA’s authorization for 23andMe’s BRCA1/BRCA2 (Selected Variants) Genetic...
FDA Approves Ibrutinib in Combination With Obinutuzumab in Treatment-Naive CLL/SLL
ON JANUARY 28, 2019, the U.S. Food and Drug Administration (FDA) approved ibrutinib (Imbruvica), a Bruton’s tyrosine kinase inhibitor, in combination with obinutuzumab in treatment-naive patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). This is the first approval of...
FDA Pipeline: Treatments for Tenosynovial Giant Cell Tumor and Pancreatic Cancer, Plus a Statement on Breast Implant–Associated Lymphoma
The U.S. Food and Drug Administration (FDA) recently granted the following designations and applications and also issued a statement: Priority Review for Pexidartinib in Tenosynovial Giant Cell Tumor The FDA has accepted a new drug application (NDA) and granted Priority Review for pexidartinib...
FDA Approves Caplacizumab-yhdp for Acquired Thrombotic Thrombocytopenic Purpura
Today, the U.S. Food and Drug Administration approved caplacizumab-yhdp (Cablivi) injection, the first therapy specifically indicated, in combination with plasma exchange and immunosuppressive therapy, for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), a...
American Lung Association's State of Tobacco Control Report Released
According to the American Lung Association’s recently released 2019 State of Tobacco Control report, states and the federal government have not taken meaningful action in establishing policies to prevent and reduce tobacco use, the nation's leading cause of preventable death and disease. ...
Clinical Cancer Advances 2019: ASCO Names Advance of the Year, Debuts Research Priorities for the Cancer Community
In the release of its annual report on progress against cancer, Clinical Cancer Advances 2019, ASCO recognized progress in treating rare cancers as the Advance of the Year. The report catalogs a year’s worth of remarkable research advancements, reinforces the need for continued federal research...
Multiple Myeloma Pipeline Filled With CAR T-Cell Therapies
The burgeoning pipeline of chimeric antigen receptor (CAR) T-cell therapies targeting B-cell maturation antigen (BCMA) in multiple myeloma was on full display at the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition. A bispecific antibody also made its debut in this busy...
Selected Abstracts From the San Antonio Breast Cancer Symposium
Each year, The ASCO Post asks Jame Abraham, MD, FACP, Director of the Breast Oncology Program at Taussig Cancer Institute and Professor of Medicine at the Cleveland Clinic Lerner College of Medicine, to offer his picks for the most important research presented at the 2018 San Antonio Breast Cancer ...
Essential Elements of an Effective Clinical Trials System: Business and Mission
Clinical trials aimed to improve health and quality of life are the cornerstone of progress in medicine. Support comes from academic medical centers, philanthropy, the National Institutes of Health (NIH), industry, or combinations thereof. Clinical trials need to be hypothesis-driven and address...
FDA Expands Pemetrexed Label With Combination of Pembrolizumab and Platinum Chemotherapy for the First-Line Treatment of Metastatic Nonsquamous NSCLC
Today, the U.S. Food and Drug Administration (FDA) granted approval for a new indication for pemetrexed (Alimta) for injection in combination with pembrolizumab (Keytruda) and platinum chemotherapy for the first-line treatment of patients with metastatic nonsquamous non–small cell...
ASCO Clinical Cancer Advances 2019 Names Advance of the Year: Progress in Treating Rare Cancers
Over the past year, major research advances provided new treatment options for patients with rare, difficult-to-treat cancers. In recognition of these achievements, ASCO named “Progress in Treating Rare Cancers” as the Advance of the Year. To continue the forward momentum, ASCO also...
FDA Pipeline: Updates on Treatments in NSCLC and Lymphomas, Plus New Dosimetry Software
The U.S. Food and Drug Administration (FDA) recently granted the following application, designations, and clearance: sBLA for Atezolizumab Plus Chemotherapy for First-Line Treatment of Metastatic, Nonsquamous NSCLC On January 17, the FDA accepted a supplemental biologics license application...
FDA Approves Ibrutinib in Combination With Obinutuzumab in Treatment-Naive CLL/SLL
Today, the U.S. Food and Drug Administration (FDA) approved ibrutinib (Imbruvica), a Bruton's tyrosine kinase inhibitor, in combination with obinutuzumab in treatment-naive patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). This is the first approval of a...
Amy Abernethy, MD, PhD, Named Principal Deputy Commissioner of Food and Drugs
ON DECEMBER 17, 2018, the U.S. Food and Drug Administration (FDA) announced that Amy Abernethy, MD, PhD, will replace Rachel Sherman, MD, MPH, as Principal Deputy Commissioner of Food and Drugs. Dr. Abernethy most recently served as Chief Medical Officer, Chief Scientific Officer, and Senior Vice...
How to Save Billions on Cancer Care Costs: The Potential of Value-Based Prescribing in Oncology
IT IS TIME for value-based prescribing—the reduction of prescribing costs using basic pharmacologic principles—to be tested and deployed in oncology. The savings are real and there for the taking. If you are concerned about the high costs in cancer care, here is a chance to get maximum value for...
Over 40 Medical Organizations Call for an End to the Government Shutdown
Forty-six medical advocacy organization and professional societies have called on President Donald Trump, Speaker of the House Nancy Pelosi, Senate Majority Leader Mitch McConell, Senate Minority Leader Chuck Schumer, and House Minority Leader Kevin McCarthy to end the government shutdown and, in...
23andMe Receives FDA Clearance for Direct-to-Consumer Genetic Test on a Hereditary Colorectal Cancer Syndrome
On January 22, 23andMe received U.S. Food and Drug Administration (FDA) clearance for a genetic health risk report on MUTYH-associated polyposis, a hereditary colorectal cancer syndrome. The clearance follows the FDA’s authorization for 23andMe’s BRCA1/BRCA2 (Selected Variants)...
