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Showing 1551 - 1600NovoTTF-100L System in Combination With Chemotherapy Approved for Malignant Pleural Mesothelioma
On May 23, the U.S. Food and Drug Administration (FDA) approved the NovoTTF-100L System in combination with pemetrexed plus platinum-based chemotherapy for the first-line treatment of unresectable locally advanced or metastatic malignant pleural mesothelioma. NovoTTF-100L is a noninvasive,...
Alpelisib Plus Fulvestrant Approved for PIK3CA-Mutated Breast Cancer
On May 24, the U.S. Food and Drug Administration (FDA) approved the PIK3CA inhibitor alpelisib (Piqray) tablets to be used in combination with the FDA-approved endocrine therapy fulvestrant to treat postmenopausal women and men with hormone receptor–positive, HER2-negative, PIK3CA-mutated, advanced ...
How Have We Got It So Wrong?
The past 20 years have seen an unprecedented increase in the development of effective drugs for the management of cancer. The advent of immunotherapy offers even the promise of cure for some previously highly resistant diseases. The science is brilliant, the need is ever increasing—but the cost is ...
Richard Pazdur, MD, on the Launch of Project Facilitate
Richard Pazdur, MD, Director of the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence and Acting Director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, discusses the launch of Project Facilitate, a new pilot program to...
FDA Announces Project Facilitate
Today, the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence announced a new pilot program to assist oncology health-care professionals in requesting access to unapproved therapies for patients with cancer. A new call center designated Project Facilitate will be a single point...
FDA Approves Addition of Survival Data to Gilteritinib Label for Refractory FLT3-Mutated AML
On May 29, the U.S. Food and Drug Administration (FDA) approved the addition of overall survival data in the labeling for gilteritinib (Xospata), which is indicated for adult patients who have relapsed or refractory acute myeloid leukemia (AML) with an FLT3 mutation as detected by an FDA-approved...
Median Lag Time for First-in-Human to First-in-Child Oncology Trials
Cancer drugs approved by the U.S. Food and Drug Administration (FDA) took a median of 6.5 years to advance from the first clinical trial in adults to the first trial in children, according to a study published by Neel et al in the European Journal of Cancer. “Despite knowing that these...
FDA Oncology Drug Approvals Granted Between May 21, 2018 and May 14, 2019
Over the past year (May 2018–May 2019), the U.S. Food and Drug Administration (FDA) granted approval and accelerated approval to a number of new oncology drugs and biosimilars. Here we list the new FDA-approved labels and indications. AVELUMAB (BAVENCIO) and AXITINIB (INLYTA) has been approved as a ...
FDA Approves Lenalidomide in Combination for Previously Treated Follicular and Marginal Zone Lymphomas
Today, the U.S. Food and Drug Administration (FDA) approved lenalidomide (Revlimid) in combination with a rituximab product for previously treated follicular and marginal zone lymphoma. AUGMENT and MAGNIFY Trials Approval was based on two clinical trials: AUGMENT and MAGNIFY. In AUGMENT, 358...
FDA Approves Alpelisib in Combination With Fulvestrant for PIK3CA-Mutated, Hormone Receptor–Positive Advanced Breast Cancer
On May 24, the U.S. Food and Drug Administration (FDA) approved alpelisib (Piqray) tablets to be used in combination with the FDA-approved endocrine therapy fulvestrant to treat postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2...
FDA Approves the NovoTTF-100L System in Combination With Chemotherapy for Malignant Pleural Mesothelioma
On May 23, the U.S. Food and Drug Administration (FDA) approved the NovoTTF-100L System in combination with pemetrexed plus platinum-based chemotherapy for the first-line treatment of unresectable locally advanced or metastatic malignant pleural mesothelioma. NovoTTF-100L is a noninvasive,...
FDA Approves Ruxolitinib for Acute Graft-vs-Host Disease
On May 24, the U.S. Food and Drug Administration (FDA) approved ruxolitinib (Jakafi) for steroid-refractory acute graft-vs-host disease (GVHD) in adult and pediatric patients 12 years and older. REACH1/Study INCB 18424-271 Approval was based on the REACH1 trial/Study INCB 18424-271, an...
Emily Whitehead, Early Recipient of CAR T-Cell Therapy for ALL, Celebrates 7 Years Cancer-Free
Among the success stories in the treatment of acute lymphoblastic leukemia (ALL) in children and young adults is the development of chimeric antigen receptor (CAR) T-cell therapy. The field of cellular immunotherapy was still in its infancy in 2012 when Emily Whitehead, then 7, became the first...
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 REACH-2...
Capsaicin
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. In this installment, Shelly Latte-Naor, MD, and Jyothirmai Gubili, MS, explore the use of...
Erdafitinib for Metastatic Urothelial Carcinoma
On April 12, 2019, erdafitinib was granted accelerated approval for patients with locally advanced or metastatic urothelial carcinoma with susceptible fibroblast growth factor receptor 3 (FGFR3) or FGFR2 genetic alterations, when the disease has progressed during or following platinum-containing...
FDA Approves Chemotherapy-Free Regimen, Venetoclax Plus Obinutuzumab, as First-Line Treatment for CLL/SLL
On May 15, the U.S. Food and Drug Administration (FDA) approved venetoclax (Venclexta) in combination with obinutuzumab (Gazyva) for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Approval was based on the CLL14...
FDA Expands Pembrolizumab Indication for NSCLC in First-Line Setting
On April 14, 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....
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 ...
Prolonged Exposure to Ibrutinib May Increase Effectiveness of CAR T-Cell Therapy in Patients With CLL
Chimeric antigen receptor (CAR) T-cell therapy has shown remarkable efficacy in the treatment of certain hematologic malignancies, including several types of large B-cell non-Hodgkin lymphomas (NHLs) and acute lymphoblastic leukemia (ALL). The U.S. Food and Drug Administration (FDA) has approved...
Introducing CancerLinQ® 2.0 and a New Era in Precision Oncology
In just 5 years since its launch in 2014, CancerLinQ®, ASCO’s big-data, rapid-learning, health information technology platform, has grown from 37 vanguard oncology practices to 58 participating practices in 2016 to 100 diverse oncology practices nationwide this year. CancerLinQ...
Researchers Supported by Conquer Cancer, the ASCO Foundation, Earn Spot in Clinical Cancer Advances 2019
The work of nine researchers who have previously received funding from Conquer Cancer is featured in ASCO’s Clinical Cancer Advances 2019. Visit CONQUER.ORG/CCA for more details. In two separate trials, Conquer Cancer–supported investigators produced research results that improved treatment for...
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) therapy as...
FDA Approves T-DM1 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...
2019 Updates to NCCN Clinical Practice Guidelines in Genitourinary Oncology
The 24th Annual Conference of the National Comprehensive Cancer Network® (NCCN®) was held this past March in Orlando, Florida. Updates to a number of Clinical Practice Guidelines (NCCN Guidelines®) were reported, including three relevant to the field of genitourinary oncology: kidney cancer,...
New 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...
