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Showing 1601 - 1650New Drugs and Novel Indications for Genitourinary Cancers, FDA Approved 2017–2019
May 14, 2019: Avelumab (Bavencio) plus axitinib (Inlyta) for the first-line treatment of patients with advanced renal cell carcinoma (RCC). April 19, 2019: Pembrolizumab (Keytruda) plus axitinib (Inlyta) for the first-line treatment of patients with advanced renal cell carcinoma (RCC). April 12,...
Front-Line Therapy in Advanced Renal Cell Carcinoma: Developing a New Standard
THE FRONT-LINE systemic treatment landscape for metastatic renal cell carcinoma has undergone tremendous movement over the past several years. A better understanding of the current management paradigm for therapy-naive patients warrants a reflection of historic landmark clinical trials that have...
NCCN Clinical Practice Guidelines in Oncology: 2019 Updates
In 1996, the National Comprehensive Cancer Network® (NCCN®) published its first set of Clinical Practice Guidelines in Oncology (NCCN Guidelines®), covering eight tumor types. NCCN Guidelines are now published for more than 70 tumor types and topics. Some of the key updates for 2019 were presented...
A Year in Review
The past year has seen groundbreaking advances in the treatment of genitourinary (GU) cancers, which in some cases are resulting in altering the standard of care for patients with renal cell carcinoma, prostate cancer, and urothelial carcinoma. Some of the biggest changes that have occurred are for ...
FDA Pipeline: Designations in Myeloma, Adenoid Cystic Carcinoma, and Kaposi Sarcoma, Plus ODAC Votes
This week, the U.S. Food and Drug Administration granted designations in relapsed or refractory multiple myeloma, adenoid cystic carcinoma, and Kaposi sarcoma; and the FDA’s Oncologic Drugs Advisory Committee (ODAC) held votes on treatments for tenosynovial giant cell tumor and acute...
Control Arm Quality in Randomized Oncology Trials Leading to FDA Approval
In a study reported in JAMA Oncology, Hilal et al found that 17% of recent cancer drug approvals based on randomized controlled trials featured a suboptimal control arm. Study Details The study involved analysis of a total of 145 studies that led to 143 drug approvals between January 2013 and...
FDA Approves Dalteparin Sodium for VTE in Pediatric Patients
On May 16, 2019, the U.S. Food and Drug Administration (FDA) approved dalteparin sodium (Fragmin) to reduce the recurrence of symptomatic venous thromboembolism (VTE) in pediatric patients 1 month of age and older. This is the first FDA-approved therapy to treat VTE in pediatric patients....
FDA Approves Chemotherapy-Free Regimen, Venetoclax Plus Obinutuzumab, as First-Line Treatment for CLL/SLL
The U.S. Food and Drug Administration (FDA) has approved venetoclax (Venclexta) in combination with obinutuzumab (Gazyva) for the treatment of people with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The approval is based on the results of the...
FDA Approves Avelumab/Axitinib Combination for Advanced Renal Cell Carcinoma
On May 14, the U.S. Food and Drug Administration (FDA) approved avelumab (Bavencio) in combination with axitinib (Inlyta) for the first-line treatment of patients with advanced renal cell carcinoma (RCC). This is the first FDA approval for an anti–programmed cell death ligand 1 (PD-L1)...
FDA Approves Ramucirumab for Hepatocellular Carcinoma
On May 10, the U.S. Food and Drug Administration (FDA) approved ramucirumab (Cyramza) as a single agent for hepatocellular carcinoma in patients who have an alpha-fetoprotein (AFP) level ≥ 400 ng/mL and have been previously treated with sorafenib. REACH-2 Trial Approval was based on the...
FDA Advances Policy Changes to Modernize Mammography Services
ON MARCH 27, 2019, the U.S. Food and Drug Administration (FDA) announced important new steps to modernize breast cancer screening and help empower patients with more information when they are considering important decisions regarding their breast health care. For the first time in more than 20...
Front-Line Therapy in Advanced Renal Cell Carcinoma: Developing a New Standard
THE FRONT-LINE systemic treatment landscape for metastatic renal cell carcinoma has undergone tremendous movement over the past several years. A better understanding of the current management paradigm for therapy-naive patients warrants a reflection of historic landmark clinical trials that have...
FDA Pipeline: Designations in Triple-Negative Breast Cancer, ctDNA Detection
This week, the U.S. Food and Drug Administration (FDA) granted a Fast Track designation to a treatment for CCR5-positive metastatic triple-negative breast cancer; granted Breakthrough Device designation to a test for the postsurgical detection and quantification of circulating tumor DNA (ctDNA);...
FDA Approves Ado-Trastuzumab Emtansine for HER2-Positive Early Breast Cancer
On May 3, the U.S. Food and Drug Administration (FDA) approved ado-trastuzumab emtansine (T-DM1; Kadcyla) for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane- and trastuzumab-based treatment. Patients should be...
FDA Pipeline: Applications and Designations in Prostate Cancer, Leukemia, and HER2-Positive Cancers
In the past 2 weeks, the U.S. Food and Drug Administration (FDA) accepted a new drug application and granted Priority Review for a prostate cancer treatment, granted Orphan Drug designation to a treatment for acute lymphoblastic leukemia, accepted an investigational new drug application for a...
FDA Approves First-Line Ivosidenib for IDH1-Mutated AML
On May 2, the U.S. Food and Drug Administration (FDA) expanded its approval of ivosidenib (Tibsovo) to include newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved test, in patients who are at least 75 years old or who have comorbidities that ...
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,1 including updates on regulatory reviews and initiatives, OCE programs, guidances, and more. The OCE is tasked with clinical medical oncology reviews, irrespective of whether the...
FDA Grants Accelerated Approval to Erdafitinib for Metastatic Urothelial Carcinoma
On April 15, 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...
Register Now for the ASCO/FDA Workshop on Oncology Clinical Trial Outcomes
Registration is now open for the 4th Annual U.S. Food and Drug Administration (FDA) Clinical Outcome Assessments in Cancer Clinical Trials Workshop, which will take place on July 12 at the FDA White Oak Campus in Silver Spring, Maryland. The 1-day workshop, which will be co-hosted by ASCO and the...
Ramucirumab After Sorafenib in Advanced Hepatocellular Carcinoma: An Efficacious Therapy With Applicability Challenges
In the 2 years since the U.S. Food and Drug Administration’s (FDA) approval of regorafenib in the treatment of patients with sorafenib-refractory advanced hepatocellular carcinoma, we oncologists have witnessed a veritable avalanche of newly approved medicines for the treatment of advanced...
Biomarkers Can Now Help Guide Treatment Selections in Breast Cancer
A growing list of biomarkers is beginning to drive targeted therapy in breast cancer, and clinicians can take advantage of these assays to make treatment selections, Debu Tripathy, MD, Professor of Medicine and Chair of Breast Medical Oncology at The University of Texas MD Anderson Cancer Center,...
The Evolving Role of Pathologists in the Diagnosis and Treatment of Cancer
In the past, the role of the pathologist was primarily to present anatomic pathology findings on various specimens, particularly at tumor boards. However, in the emerging age of personalized medicine and molecular diagnostics, the responsibilities of pathologist have greatly expanded into...
The Microbiome: The Next Target in Cancer Therapy
With the recent breakthroughs in immunotherapy, treatments that modulate the immune system are now being used across numerous cancer types and across the spectrum of disease with significant success, but not all patients achieve objective responses. There is still a critical need to better...
FDA Approves Pembrolizumab Plus Axitinib for First-Line Treatment of Advanced Renal Cell Carcinoma
On April 19, 2019, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) plus axitinib for the first-line treatment of patients with advanced renal cell carcinoma (RCC). KEYNOTE-426 Approval was based on KEYNOTE-426, a randomized, multicenter, open-label trial conducted in ...
FDA Pipeline: Designations for Myelodysplastic Syndromes, Triple-Negative Breast Cancer, AML, and EBV-Associated Cancers
Over the past week, the U.S. Food and Drug Administration (FDA) granted several Fast Track and Orphan Drug designations to treatments for myelodysplastic syndromes, triple-negative breast cancer, acute myeloid leukemia (AML), and Epstein-Barr virus (EBV)-associated cancers. Fast Track Designation...
FDA 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...
