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Showing 1651 - 1700FDA 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)...
FDA Approves Biosimilar Trastuzumab-dttb
On January 18, the U.S. Food and Drug Administration (FDA) approved trastuzumab-dttb (Ontruzant), a biosimilar referencing trastuzumab, across all eligible indications—namely, adjuvant treatment of HER2-overexpressing breast cancer, metastatic breast cancer, and metastatic gastric cancer or...
FDA Approves Cabozantinib in Previously Treated Hepatocellular Carcinoma
On January 14, the U.S. Food and Drug Administration (FDA) approved cabozantinib (Cabometyx) tablets for patients with hepatocellular carcinoma who have been previously treated with sorafenib. The FDA’s approval of this oral tyrosine kinase inhibitor was based on the results of the phase III...
Study Finds High Tumor Mutational Load Is a Predictor of Response to Immunotherapy in Some Cancers
Although the emergence of immune checkpoint inhibitors over the last decade has revolutionized the treatment of patients with metastatic cancers, only a minority of patients experience long-lasting benefit from the therapy. A study investigating the association between tumor mutational burden and...
Comorbidities and Cancer Clinical Trial Enrollment
Patients diagnosed with cancer who also have other illnesses or conditions, such as hypertension, asthma, or a prior cancer, are less likely to talk with their health-care provider about a cancer clinical trial, are less likely to be offered to join a clinical trial, and are ultimately less likely...
FDA Approves Cabozantinib for Previously Treated Hepatocellular Carcinoma
On January 14, the U.S. Food and Drug Administration (FDA) approved cabozantinib (Cabometyx) tablets for patients with hepatocellular carcinoma who have been previously treated with sorafenib. The FDA’s approval of cabozantinib was based on results from the phase III CELESTIAL trial....
FDA Pipeline: Designations for Treatments of Graft-vs-Host-Disease, Colorectal Cancer, Pancreatic Cancer, and More
The U.S. Food and Drug Administration (FDA) recently issued the following new designations and clearances: Fast Track Designation for Itolizumab for the Treatment of Acute Graft-vs-Host Disease The FDA granted Fast Track designation to itolizumab for the treatment of acute graft-vs-host ...
FDA Expands Indication for Dasatinib to Pediatric Patients With Ph+ ALL in Combination With Chemotherapy
On January 2, the U.S. Food and Drug Administration (FDA) expanded the indication for dasatinib (Sprycel) tablets to include the treatment of pediatric patients 1 year of age and older with newly diagnosed Philadelphia chromosome–positive (Ph+) acute lymphoblastic leukemia (ALL) in...
FDA Approves Ravulizumab-cwvz for Paroxysmal Nocturnal Hemoglobinuria
On December 21, 2018, the U.S. Food and Drug Administration (FDA) approved ravulizumab-cwvz (Ultomiris) for adult patients with paroxysmal nocturnal hemoglobinuria (PNH). PNH is a rare bone marrow failure disorder that manifests with hemolytic anemia, thrombosis, and peripheral blood cytopenias....
FDA Approves Tagraxofusp-ezrs for Blastic Plasmacytoid Dendritic Cell Neoplasm
On December 21, the U.S. Food and Drug Administration (FDA) approved tagraxofusp-erzs (Elzonris) infusion for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients aged 2 years and older. “Prior to [this] approval, there had been no...
Breakthrough Therapy Designation for Brentuximab Vedotin in Front-Line Treatment of Peripheral T-Cell Lymphomas
THE FDA recently granted Breakthrough Therapy designation to brentuximab vedotin (Adcetris) for previously untreated systemic anaplastic large cell lymphoma or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in ...
Priority Review for Quizartinib in Relapsed or Refractory FLT3-ITD–Positive AML
THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) accepted a new drug application and granted Priority Review to quizartinib, a FLT3 inhibitor, for the treatment of adult patients with relapsed or refractory FLT3-ITD–positive acute myeloid leukemia (AML). The FDA is expected to make a decision on...
Pembrolizumab in Sorafenib-Pretreated Hepatocellular Carcinoma
ON NOVEMBER 9, 2018, pembrolizumab (Keytruda) was granted accelerated approval for treatment of patients with hepatocellular carcinoma previously treated with sorafenib (Nexavar).1,2 Supporting Efficacy Data APPROVAL WAS BASED on durable responses in the phase II KEYNOTE-224 trial...
Venetoclax in Combination Regimens for Older Patients With AML or Those With Comorbidities Precluding Intensive Induction
On November 21, 2018, venetoclax (Venclexta) was granted accelerated approval for use in combination with azacitidine or decitabine or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in patients aged ≥ 75 years or who have comorbidities that preclude the use of ...
Illustrating Genius
FOUR AND A HALF YEARS AGO, author Neil Canavan attended a scientific conference to learn what he could about the then-emerging field of immunotherapy for cancer. After a presentation by Zelig Eshhar, PhD, principal investigator in the Department of Immunology at the Weizmann Institute of Science...
FDA Announces New Updates to Expanded Access Program
The U.S. Food and Drug Administration (FDA) recently announced new changes to expand and update the Expanded Access (EA) program, which allows very ill patients access to experimental treatments outside of clinical trials. The most recent updates include: Clarifications on Safety Data: The FDA...
Lorlatinib in Second- or Third-Line Treatment of ALK-Positive Metastatic Non–Small Cell Lung Cancer
On November 2, 2018, lorlatinib (Lorbrena) was granted accelerated approval for the treatment of patients with ALK-positive metastatic non–small cell lung cancer (NSCLC) whose disease has progressed on crizotinib (Xalkori) and at least one other ALK inhibitor for metastatic disease or whose disease ...
FDA Approves Trastuzumab-pkrb for HER2-Overexpressing Breast Cancer
On December 14, the U.S. Food and Drug Administration (FDA) approved trastuzumab-pkrb (Herzuma), a HER2/neu receptor antagonist biosimilar to trastuzumab (Herceptin), for the following indications: Adjuvant breast cancer of HER2-overexpressing, node-positive or node-negative (estrogen...
FDA Approves Calaspargase Pegol-mknl for Pediatric and Young Adult Patients With ALL
On December 20, 2018, the U.S. Food and Drug Administration (FDA) approved calaspargase pegol-mknl (Asparlas), an asparagine-specific enzyme, as a component of a multiagent chemotherapeutic regimen for acute lymphoblastic leukemia (ALL) in pediatric and young adult patients aged 1 month to...
Statement From FDA Commissioner on In Vitro Companion Diagnostics
FDA Commissioner Scott Gottlieb, MD, recently issued the following statement on developing and class labeling of in vitro companion diagnostics for classes of oncology therapeutic products: “With a new draft guidance document that the FDA issued … our aim is to make it easier to get class labeling ...
Priority Review for Atezolizumab in Combination With Chemotherapy for Small Cell Lung Cancer
The U.S. Food and Drug Administration (FDA) accepted a supplemental biologics license application (sBLA) and granted Priority Review for atezolizumab (Tecentriq) in combination with carboplatin and etoposide for the first-line treatment of patients with extensive-stage small cell lung cancer. The...
Immunotherapy-Related Toxicities May Be More Common Than Originally Reported
Immunotherapy has significantly improved the overall survival of patients with non–small cell lung cancer (NSCLC) and is generally better tolerated than traditional chemotherapies, but the results of a retrospective study suggested that immunotherapy side effects may be more common than initially...
New NCCN Member Institution: Abramson Cancer Center of the University of Pennsylvania
In November, the National Comprehensive Cancer Network® (NCCN) announced that Abramson Cancer Center (ACC) of the University of Pennsylvania will become the organization’s 28th Member Institution. The Abramson Cancer Center’s membership will include the Hospital of the University of Pennsylvania...
Has Scalp Cooling Reached the Level of Standard of Care?
Does evidence of the effectiveness and safety of scalp cooling to reduce hair loss among women being treated for breast cancer mean that scalp cooling is a new standard of care? “I would suggest that it is,” stated Mikel Ross, MSN, RN, AGNP-BC, of the Breast Medicine Service, Memorial Sloan...
FDA Issues Guidance on Endpoints for Cancer Clinical Trials
This week, the U.S. Food and Drug Administration (FDA) issued a guidance titled Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics. The guidance provides recommendations to applicants on endpoints for cancer clinical trials submitted to the FDA to support effectiveness claims...
AI Technology for Digital Breast Tomosynthesis Receives FDA Clearance for Clinical Use
A deep-learning, cancer detection software built on artificial intelligence (AI) called ProFound AI received clearance by the U.S. Food and Drug Administration (FDA) for commercial sales and clinical use in the United States. The announcement was made in a news release from iCAD, Inc., a global...
