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Showing 1601 - 1650FDA Grants Accelerated Approval to Erdafitinib for Metastatic Urothelial Carcinoma
Today, the U.S. Food and Drug Administration (FDA) granted accelerated approval to erdafitinib (Balversa) for patients with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 or FGFR2 genetic alterations that has progressed during or following platinum-containing...
FDA Pipeline: Designation in Uveal Melanoma, Application for MDS Side-Effect Management
Over the past week, the U.S. Food and Drug Administration (FDA) granted a Fast Track designation to a treatment for metastatic uveal melanoma and received a biologics application for an agent to control anemia. Fast Track Designation for Tebentafusp in Metastatic Uveal Melanoma The FDA granted...
FDA Expands Pembrolizumab Indication for NSCLC in First-Line Setting
Today, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for the first-line treatment of patients with stage III non–small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation, or those with metastatic NSCLC....
ASCO in Action Policy Podcast Features Exclusive Interviews With Top Leadership at FDA, NCI
OVER THE PAST several months, the ASCO in Action Podcast has secured exclusive interviews with high-ranking officials to discuss health policy issues affecting the United States. In March, the Director of the National Cancer Institute (NCI) and U.S. Food and Drug Administration (FDA) Acting...
Human Gene Therapy: Progress and Oversight
The early debate over the social and ethical implications of gene therapy led the National Institutes of Health (NIH) to establish the Recombinant DNA Advisory Committee in 1974. However, the risks of human gene therapies were largely unknown until 1999, when a patient died of a massive immune...
FDA Warning: Investigational Use of Venetoclax in Multiple Myeloma
On March 21, 2019, the U.S. Food and Drug Administration (FDA) posted a safety statement on the investigational use of venetoclax in multiple myeloma. The statement alerts health-care professionals and patients about the suspension of the BELLINI trial (ClinicalTrials.gov identifier NCT02755597) of ...
FDA Approves Atezolizumab for Extensive-Stage Small Cell Lung Cancer
On March 18, 2019, the U.S. Food and Drug Administration (FDA) approved atezolizumab (Tecentriq) in combination with carboplatin and etoposide for the first-line treatment of adult patients with extensive-stage small cell lung cancer. Approval was based on the IMpower133 study (ClinicalTrials.gov...
CELESTIAL Trial in Advanced Hepatocellular Carcinoma: Analysis on Quality-Adjusted Life-Years
ON JANUARY 14, 2019, the U.S. Food and Drug Administration (FDA) approved cabozantinib, an orally available receptor tyrosine kinase inhibitor, for patients with hepatocellular carcinoma who have been previously treated with sorafenib. The FDA’s approval was based on the results of the phase III...
FDA Pipeline: Designations in Glioblastoma, Neurofibromatosis, Multiple Myeloma, and AML
This week, the U.S. Food and Drug Administration (FDA) granted designations for treatments for recurrent glioblastoma, neurofibromatosis type 1 and plexiform neurofibromas, multiple myeloma, and relapsed or refractory FLT3-ITD acute myeloid leukemia (AML). Fast Track Designation for Ad-RTS-hIL-12...
FDA Expands Palbociclib Indication in HR-Positive, HER2-Negative Breast Cancer to Include Male Patients
Today, the U.S. Food and Drug Administration (FDA) extended the indication of palbociclib (Ibrance) capsules in combination with specific endocrine therapies for hormone receptor (HR)–positive, HER2-negative advanced or metastatic breast cancer to include male patients. “Today, we are...
AACR 2019: Phase I Trial Evaluates LOXO-195 in Patients With NTRK-Positive Solid Tumors
The investigational anticancer therapeutic LOXO-195, which targets a family of proteins called tropomyosin receptor kinases (TRKs), was safe, tolerable, and showed signs of clinical activity in patients who had solid tumors that harbored NTRK gene fusions and had become resistant to other...
AACR 2019: Gilteritinib in Patients With FLT3-Mutated Acute Myeloid Leukemia
Treatment with the FLT3-targeted therapeutic gilteritinib improved survival for patients with relapsed or refractory acute myeloid leukemia (AML) harboring an FLT3 mutation compared with standard chemotherapy regimens, according to results from the phase III ADMIRAL trial presented by Perl et al at ...
FDA Oncology Center of Excellence Issues Annual Report
The U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) has issued its 2018 Annual Report, including updates on regulatory reviews and initiatives, OCE programs, guidances, and more. Regulatory Reviews The OCE is tasked with clinical medical oncology reviews, irrespective...
FDA Pipeline: Mammography Policies, Designations for Leukemias and Myelodysplastic Syndrome
This week, the U.S. Food and Drug Administration (FDA) announced policy changes to modernize mammography policies and issued a Breakthrough Therapy designation, an Orphan Drug designation, and an investigational new drug application. FDA Advances Policy Changes to Modernize Mammography Services...
ASCO Weighs in on Widespread Youth Tobacco Use: See the Latest National Youth Tobacco Survey Results
APPROXIMATELY 5 MILLION middle and high school students reported currently using a tobacco product, with over 3.6 million currently using e-cigarettes and about 2.5 million currently using a combustible tobacco product, according to the latest findings from the National Youth Tobacco Survey ...
IMpassion130 Substudy: Atezolizumab/Nab-Paclitaxel Survival Benefits Limited to PD-L1–Positive Triple-Negative Breast Cancer
THE PHASE III IMpassion130 trial, first reported at the European Society for Medical Oncology (ESMO) 2018 Congress1 and published in The New England Journal of Medicine,2 found that the combination of front-line atezolizumab plus nab-paclitaxel significantly improved disease-free and overall...
FDA Grants Accelerated Approval to Atezolizumab/ Nab-paclitaxel in Triple-Negative Breast Cancer
ON MARCH 8, the U.S. Food and Drug Administration (FDA) granted accelerated approval to atezolizumab (Tecentriq) plus nab-paclitaxel (Abraxane) for the treatment of adults with unresectable, locally advanced or metastatic, PD-L1–positive triple-negative breast cancer. PD-L1 status is determined by...
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 in April. In a resignation letter to Alex M. Azar II, Secretary of Health and Human Services (HHS),...
Trastuzumab Biosimilar for HER2-Overexpressing Breast Cancer
ON DECEMBER 14, 2018, trastuzumab-pkrb (Herzuma) was approved as a biosimilar to trastuzumab for patients with HER2-overexpressing breast cancer.1 Trastuzumab-pkrb is indicated for adjuvant treatment of HER2-overexpressing breast cancer and metastatic HER2-overexpressing breast cancer.2 Health-care ...
Breast Density Assessment Variation by Screening Modality
Fewer women are assigned to a dense-breast category when evaluated with advanced mammographic screening technologies compared to standard digital mammography, according to a new study published by Gastounioti et al in Radiology. Density Assessment A woman’s breast density is assessed during ...
Immunotherapy Directed Against Precancerous Skin Lesions May Prevent Squamous Cell Carcinoma
A treatment previously shown to treat the precancerous skin lesions called actinic keratosis now appears to also reduce the chance that these pretreated lesions will develop into squamous cell carcinoma. In a report published by Rosenberg et al in JCI Insight, researchers found that treatment with...
FDA Pipeline: Safety Warning About Investigational Use of Venetoclax in Multiple Myeloma, Warning Letter on Unapproved Products
This week, the U.S. Food and Drug Administration (FDA) posted a safety statement on the investigational use of venetoclax in multiple myeloma, and also posted a warning letter against a company for illegally marketing unapproved products labeled as homeopathic. Safety Statement The FDA posted...
Heather A. Wakelee, MD, on Advanced Non–Small Cell Lung Cancer: State-of-the-Art Treatment for EGFR-Positive and ALK-Positive Diseases
Heather A. Wakelee, MD, of Stanford University, discusses the most recent FDA-approved tyrosine kinase inhibitors that target EGFR and ALK mutations, how these agents fit into the treatment landscape, and the rapidly evolving field of TKI resistance.
FDA Approves Atezolizumab for Extensive-Stage Small Cell Lung Cancer
On March 18, 2019, the U.S. Food and Drug Administration (FDA) approved atezolizumab (Tecentriq) in combination with carboplatin and etoposide for the first-line treatment of adult patients with extensive-stage small cell lung cancer. IMpower133 Approval was based on the IMpower133 study, a...
The Risks of Drug Approval Based on Shaky Evidence
Two recent publications in The New England Journal of Medicine (NEJM), and the resulting drug approval applications that have already been filed, lead to concern that the basis of medical practice on valid evidence may be corrupted. Each involves statistically shaky analysis leading to a striking...
CAR 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...
