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Showing 651 - 700Study Identifies Three-Gene Signature That May Predict Response to Selinexor in Patients With Multiple Myeloma
Researchers have, for the first time, identified genes that may predict response to a therapy for a blood cancer that can have serious side effects for some patients. The therapy, selinexor, is part of the treatment armamentarium for multiple myeloma, but the ability to target its use to patients...
FDA Authorizes Moderna and Pfizer-BioNTech COVID-19 Vaccines for Children as Young as 6 Months of Age
On June 17, the U.S. Food and Drug Administration (FDA) authorized emergency use of the Moderna COVID-19 vaccine and the Pfizer-BioNTech COVID-19 vaccine for the prevention of COVID-19 to include use in children as young as 6 months of age. For the Moderna vaccine, the FDA amended the emergency...
Postmarketing Ocular Toxicity in U.S. Adults Treated With Daratumumab
In an analysis reported in a research letter in JAMA Oncology, Nguyen et al identified postmarketing cases of ocular toxicity in patients receiving daratumumab in the United States. Daratumumab is a CD38-directed monoclonal antibody that was initially approved in 2015 for the treatment of multiple...
Elevating Cancer Care in the United States for All: Current Challenges and Potential Solutions
Optimizing oncology care in the United States will require making state-of-the-art care more accessible to all. Delivering quality, equitable cancer care is undoubtedly a challenge in a country as large, diverse, and disparate as the United States, but if it is to be achieved, it will entail the...
Emily Whitehead, First Pediatric Patient to Receive CAR T-Cell Therapy, Celebrates Remission 10 Years Later
Tom and Kari Whitehead came to Children’s Hospital of Philadelphia (CHOP) 10 years ago looking for a miracle. Their 6-year-old daughter, Emily, had relapsed in her battle with acute lymphoblastic leukemia (ALL), after many months of unsuccessful chemotherapy and a disease that had progressed so...
FDA Approves FoundationOne CDx as a Companion Diagnostic for Entrectinib
On June 9, Foundation Medicine, Inc., announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne CDx to be used as a companion diagnostic for the two indications of the tyrosine kinase inhibitor entrectinib (Rozlytrek). As a companion diagnostic,...
Adagrasib Improves Outcomes in KRAS-Mutated NSCLC, Phase II Study Shows
Nearly 43% of patients with non–small cell lung cancer (NSCLC) whose lung cancers harbored a specific KRAS mutation responded to the experimental drug adagrasib, and the targeted agent also showed activity against lesions in the brain that metastasized from the lung tumors, according to results of...
FDA Approvals in Esophageal Cancer and Follicular Lymphoma
Last week, the FDA approved treatments for esophageal cancer and follicular lymphoma. On this episode, we’ll review the data supporting those approvals and hear from researchers involved in the trials investigating the efficacy of these regimens.
New FDA-Approved Oncology Drugs (2021–2022)
Over the past year (May 2021–May 2022), the U.S. Food and Drug Administration (FDA) approved and expanded indications for many drugs related to the treatment of different types of cancers and adverse events. The new approvals and accelerated approvals are listed below. FAM-TRASTUZUMAB...
Missed Opportunities in Geriatric Oncology Research
The underrepresentation of older patients (≥ 65 years) in clinical trials has been well documented for more than 20 years. This has been an issue at all phases of drug development, including pivotal trials for drug approvals,1 despite the fact that many of these new therapeutics will primarily be...
ASCO Honors 2022 Special Awards Recipients
ASCO and Conquer Cancer, the ASCO Foundation, will recognize researchers, patient advocates, philanthropists, teachers, and global oncology leaders who have reshaped cancer care around the world with the Society’s highest honors at the 2022 ASCO Annual Meeting in Chicago. “This year’s Special...
FDA Approves Two Nivolumab-Based Regimens as First-Line Treatments for Unresectable Advanced or Metastatic Esophageal Squamous Cell Carcinoma
On May 27, 2022, the U.S. Food and Drug Administration (FDA) approved the following for the first-line treatment of patients with advanced or metastatic esophageal squamous cell carcinoma: Nivolumab (Opdivo) in combination with fluoropyrimidine- and platinum-based chemotherapy Nivolumab in...
FDA Approves Tisagenlecleucel for Adult Patients With Relapsed or Refractory Follicular Lymphoma
On May 28, the U.S. Food and Drug Administration (FDA) granted accelerated approval to the chimeric antigen receptor (CAR) T-cell therapy tisagenlecleucel (Kymriah) for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy....
FDA Approval for Newly Diagnosed Acute Myeloid Leukemia
This week, we’re covering the U.S. Food and Drug Administration (FDA) approval of a doublet therapy in certain populations of patients with newly diagnosed acute myeloid leukemia. Then we’ll hear about a comparison study of treatments for patients with metastatic breast cancer and brain metastases.
FDA Approves Ivosidenib/Azacitidine for Certain Patients With Newly Diagnosed AML
On May 25, the U.S. Food and Drug Administration (FDA) approved ivosidenib (Tibsovo) in combination with azacitidine for patients with newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test in adults aged 75 or older, or who have...
ASCO Guideline Rapid Update Addresses the Use of Neoadjuvant Pembrolizumab in High-Risk Early-Stage Triple-Negative Breast Cancer
A rapid update to the ASCO Guideline on neoadjuvant therapy for breast cancer adds a recommendation on the use of pembrolizumab in patients with high-risk early-stage triple-negative breast cancer.1 The update follows a recent analysis from the randomized phase III KEYNOTE-522 trial that showed a...
A Second Edition Adds New Value to Personalized Medicine
Since the publication of the first draft of the human genome, genotyping and genomics have been integrated into standard clinical care for select cancers. But as precision medicine in oncology develops to comprise big data, proteomics, transcriptomics, molecular imaging, and more, there are...
Children’s Hospital of Philadelphia Establishes the Susan S. and Stephen P. Kelly Center for Cancer Immunotherapy
Children’s Hospital of Philadelphia (CHOP) announced it has received a significant gift from Susan and Steve Kelly, local philanthropists and long-time supporters of CHOP, to establish the Susan S. and Stephen P. Kelly Center for Cancer Immunotherapy. The new Center, led by Stephan Grupp, MD, PhD,...
PD-1 Inhibition in First-Line Treatment of Advanced Esophageal Squamous Cell Carcinoma: More to Come on New Paradigm
Esophageal cancer is associated with significant morbidity and mortality worldwide, with more than 600,000 new cases and 540,000 deaths in 2020. The squamous cell histology comprises nearly 90% of cases globally, despite its steady decline in the United States over the past 40 years. Historically,...
Pembrolizumab for MSI-H/dMMR Advanced Endometrial Carcinoma
On March 21, 2022, pembrolizumab was approved for patients with advanced endometrial carcinoma that is microsatellite instability–high (MSI-H) or mismatch repair–deficient (dMMR), as determined by a U.S. Food and Drug Administration (FDA)-approved test, who have disease progression following prior...
Steven A. Rosenberg, MD, PhD, Recognized With 2022 Pezcoller Foundation–AACR International Award
The Pezcoller Foundation–American Association for Cancer Research (AACR) International Award for Extraordinary Achievement in Cancer Research was presented to Steven A. Rosenberg, MD, PhD, at the Association’s 2022 Annual Meeting, held in New Orleans. Dr. Rosenberg was honored for his discovery and ...
FDA Approves Azacitidine for Newly Diagnosed Juvenile Myelomonocytic Leukemia
On May 20, the U.S. Food and Drug Administration approved azacitidine (Vidaza) for pediatric patients with newly diagnosed juvenile myelomonocytic leukemia (JMML). AZA-JMML-001 Efficacy was evaluated in AZA-JMML-001 (ClinicalTrials.gov identifier NCT02447666), an international, multicenter,...
Mortality and Associated Factors Among Patients With Cancer vs No Cancer Infected With SARS–CoV-2
In a systematic review and meta-analysis reported in JAMA Network Open, Khoury et al found that SARS–CoV-2 infection was associated with a higher risk of mortality among patients with cancer vs those without cancer. Risk vs those with no cancer was increased with younger age, and patients with...
Report Finds Uptake of Erdafitinib for Urothelial Cancer May Be Limited, Despite Positive Real-World Survival Data
The first bladder cancer drug targeting a cancer-driving gene mutation has been used relatively little despite its clear efficacy in a clinical trial, suggests a report published as a research letter by Nimgaonkar et al in JAMA Oncology. Researchers analyzed a large, nationwide database of cancer...
Next-Generation PARP1-Selective Inhibitor Offers Significant Benefits Over Older Predecessors in Treatment of Solid Tumors
The first-in-human, first-in-class trial of the next-generation PARP (poly [ADP-ribose] polymerase) 1–selective inhibitor AZD5305 suggests this drug may be a welcome advance over its U.S. Food and Drug Administration (FDA)-approved predecessors in the treatment of solid tumors with alterations in...
Beyond Immunotherapy: New Targeted Agents for Advanced NSCLC
The advent of PD-1 and PD-L1 checkpoint inhibitors has changed the treatment landscape of advanced non–small cell lung cancer (NSCLC), but only approximately 20% of patients treated with immunotherapy will be alive at 5 years. According to Melissa L. Johnson, MD, Director, Lung Cancer Research,...
DESTINY-Lung01: Is Trastuzumab Deruxtecan the Answer for HER2-Mutant Lung Cancer?
The human epidermal growth factor (HER) family of receptors are a well-established therapeutic target. Indeed, seminal studies conducted nearly 2 decades ago identified a key association between activating mutations in the kinase domain of the epidermal growth factor receptor (EGFR, also known as...
ASCO Honors 2022 Special Awards Recipients
ASCO and Conquer Cancer, the ASCO Foundation, will recognize researchers, patient advocates, philanthropists, teachers, and global oncology leaders who have reshaped cancer care around the world with the Society’s highest honors at the 2022 ASCO Annual Meeting in Chicago. Hear from select award...
Going the Last Mile: Accelerating Delivery of Multiple Myeloma Therapies to All Patients
When I was diagnosed with multiple myeloma in 1996, I was given 3 years to live. At the time, there was little understanding of this disease, which was termed incurable. There were no new treatments, few drugs in the pipeline, hardly any clinical trials, and no multiple myeloma community or...
FDA Approves Fam-Trastuzumab Deruxtecan-nxki for Adult Patients With Unresectable or Metastatic HER2-Positive Breast Cancer
On May 4, the FDA approved fam-trastuzumab deruxtecan-nxki for pretreated adult patients with unresectable or metastatic HER2-positive breast cancer. We highlight findings from the DESTINY-Breast03 trial that led to the regular approval, and also hear from Dr. Sara Hurvitz, of the University of...
Hematologic Oncology 2021–2022 Almanac
Ongoing evaluation of novel, targeted, and immunotherapies has led to exciting advances across the array of hematologic malignancies over the past year. The availability of new treatment options, along with emerging data on novel combinations and sequencing approaches, is rapidly changing...
Isatuximab-Containing Induction Therapy for Multiple Myeloma Increases Measurable Residual Disease Negativity
For the first-line treatment of newly diagnosed multiple myeloma, the percentage of patients achieving measurable residual disease (MRD, previously called minimal residual disease) negativity was significantly greater when the anti-CD38 monoclonal antibody isatuximab was added to a standard...
MAIA Trial: Daratumumab Added to Lenalidomide Plus Dexamethasone Improves Overall Survival in Transplant-Ineligible Multiple Myeloma
As reported in The Lancet Oncology by Thierry Facon, MD, of the Centre Hospitalier Universitaire de Lille, and colleagues, a prespecified interim analysis of overall survival in the pivotal phase III MAIA trial has shown a significant benefit with the addition of daratumumab to...
FDA Approvals in Hematologic Oncology 2021–2022
Over the past year, the U.S. Food and Drug Administration (FDA) granted approval to several novel drugs and new indications for older therapeutic agents used in hematologic oncology. Axicabtagene Ciloleucel: On April 1, 2022, axicabtagene ciloleucel (Yescarta) was approved for adult patients with...
Expert Point of View: Susan M. O’Brien, MD
The GAIA trial raises some important points, according to Susan M. O’Brien, MD, Associate Director for Clinical Research at the UCI Chao Family Comprehensive Cancer Center in Irvine, California. Dr. O’Brien co-moderated the session where Dr. Eichhorst presented study results. “The CLL14 trial...
FDA Grants Regular Approval to Fam-Trastuzumab Deruxtecan-nxki for Unresectable or Metastatic HER2-Positive Breast Cancer
On May 4, the U.S. Food and Drug Administration (FDA) approved fam-trastuzumab deruxtecan-nxki (Enhertu) for pretreated adult patients with unresectable or metastatic HER2-positive breast cancer. According to the approval, patients had to have received a prior anti-HER2–based regimen either in the...
Cancer Screening Accessibility Among Native Americans
In a scientific e-poster presented during the 2022 American Roentgen Ray Society Annual Meeting in New Orleans, Peña et al noted that American Indian and Alaskan Native populations have nearly three times higher incidence rates of lung and colorectal cancer than other ethnic groups. These patterns...
How to Get the Dose Right
OCE Insights is an occasional column developed for The ASCO Post by members of the Oncology Center of Excellence (OCE) at the U.S. Food and Drug Administration (FDA). In this installment, Mirat Shah, MD, of the Office of Oncologic Diseases, Center for Drug Evaluation and Research, FDA; Atiqur...
Study Finds CAR T-Cell Therapy Outcomes, Side Effects Are Similar in Black and Hispanic Patients Compared to White and Asian Patients
Chimeric antigen receptor (CAR) T-cell therapy has revolutionized the treatment of blood cancers, including certain leukemias, lymphomas, and multiple myeloma. However, Black and Hispanic patients were largely absent from the major clinical trials that led to the U.S. Food and Drug Administration...
PSMA-Targeted Radioligand Therapy for Metastatic Castration-Resistant Prostate Cancer
In this video, Drs. Celestia (Tia) Higano, Julie Graff, and Neal Shore discuss the role of prostate-specific membrane antigen (PSMA)-targeted radioligand therapy in the treatment of metastatic castration-resistant prostate cancer. The patient is an 81-year-old man with 13-year history of prostate...
Norman Sharpless, MD, to Step Down as Director of the NCI
Norman E. Sharpless, MD, has announced that he has decided to step down from his position as Director of the National Cancer Institute (NCI), part of the National Institutes of Health (NIH), a position he has held since 2017. Dr. Sharpless will continue as NCI Director through April 29, 2022, to...
Phase III Trials and Tribulations
Imagine this. You are a large pharmaceutical company that launches an international randomized phase III trial to assess whether one of your drugs improves the outcome of patients with a common type of cancer. The trial was solidly backed by preclinical evidence that the drug target was essential ...
Virtual Panel Explores Impact of Racism on the Cancer Burden Facing Asian Americans
On July 21, 2021, the Oncology Center of Excellence at the U.S. Food and Drug Administration (FDA) convened a panel discussion entitled “Conversations on Cancer” to address the significant cancer disparities facing Asian Americans. The virtual “conversation” focused on the unfair burden impacting...
FDA Issues New Draft Guidance to Industry for Developing Plans to Enroll Participants From Underrepresented Racial and Ethnic Populations
Recently, the U.S. Food and Drug Administration (FDA) issued a new draft guidance to industry for developing plans to enroll more participants from underrepresented racial and ethnic populations in the United States into clinical trials—expanding on the agency’s previous guidances for industry to...
Reflections on the Evolution of Clinical Care Since the Passage of the National Cancer Act of 1971
Recently, I had the honor of coauthoring a chapter with Eric P. Winer, MD, President-Elect of ASCO, on the evolution of clinical cancer care since the enactment of the National Care Act of 1971 for the book A New Deal for Cancer: Lessons From a 50-Year War, by Abbe R. Gluck and Charles S. Fuchs,...
Congress Increases Federal Funding for Cancer Research
President Biden is soon expected to sign into law the Fiscal Year (FY) 2022 omnibus funding bill, which provides funding for all federal agencies through September 30, 2022. The bill was passed by the U.S. House of Representatives and the U.S. Senate during the week of March 7, 2022. The bill...
ASCO Provisional Clinical Opinion Offers Guidance for Using and Interpreting Genomic Testing in Patients With Advanced Cancer
Somatic genomic testing should be a routine part of clinical care for many patients with metastatic or advanced solid tumors, according to a new ASCO provisional clinical opinion.1 As reported in the Journal of Clinical Oncology, the expert panel found that genomic testing in oncology practice has...
Conundrums of SARS–CoV-2 Infection in Cancer Care
The ASCO Post is pleased to present the Hematology Expert Review, an occasional feature that quizzes readers on issues in hematology. In this installment, Drs. Abutalib, Kröger, and Mikulska focus on the challenges of providing cancer care amid the COVID-19 pandemic. Here they present two...
Improving Oral Anticancer Therapy Adherence, a Call to Action, and an Upcoming FDA-ASCO Workshop
In a recently published paper in the Journal of Clinical Oncology,1 R. Donald Harvey, PharmD, BCOP, FCCP, FHOPA, of Emory University, Atlanta, and coleagues reflected on the growth in availability of oral anticancer therapies over the past decade and noted that as these treatments are easy to take ...
FDA Approves Alpelisib for PIK3CA-Related Overgrowth Spectrum
On April 5, the U.S. Food and Drug Administration (FDA) granted accelerated approval to alpelisib (Vijoice) for adult and pediatric patients aged 2 years and older with severe manifestations of PIK3CA-related overgrowth spectrum (PROS) who require systemic therapy. PROS encompasses a group of rare...
