Search Results
Your search for ,Fda matches 3728 pages
Showing 651 - 700Beyond 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...
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, a position he has held since 2017. Dr. Sharpless will continue as NCI Director through April 29, 2022, to allow...
FDA Approves Axicabtagene Ciloleucel for the Second-Line Treatment of Large B-Cell Lymphoma
On April 1, the U.S. Food and Drug Administration (FDA) approved axicabtagene ciloleucel (Yescarta) for adult patients with large B-cell lymphoma (LBCL) who are refractory to first-line chemoimmunotherapy or who experienced relapse within 12 months of first-line chemoimmunotherapy. It is not...
Study Finds Black Patients With Cancer Diagnosed With COVID-19 Have Worse Outcomes Than White Patients
Black patients with cancer experienced significantly worse outcomes after a COVID-19 diagnosis than non-Hispanic White patients, according to findings published by Fu et al in JAMA Network Open. Investigators from the COVID-19 and Cancer Consortium (CCC19) studied the electronic health records of...
FDA Approvals in Prostate and Endometrial Cancers
In this week’s episode, we are discussing two recent FDA approvals—one for prostate cancer, and the other for endometrial cancer. The radioconjugate lutetium Lu-177 vipivotide tetraxetan was approved for the treatment of adult patients with prostate-specific membrane antigen–positive metastatic...
Recent FDA Approvals in Gastrointestinal Cancer
Over the past year, the U.S. Food and Drug Administration granted approval to several novel drugs and new indications for older therapeutic agents used in gastrointestinal oncology. Cetuximab Plus Encorafenib On September 28, 2021, cetuximab (Erbitux) was approved in combination with encorafenib...
Gastrointestinal Oncology 2021–2022 Almanac
The past year has seen unprecedented progress across the spectrum of gastrointestinal malignances, including the advancement of immunotherapy and targeted molecular agents and the refinement of adjuvant therapy using novel as well as existing therapies. Three themes emerging from these reports are: ...
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...
FDA Approves Radioligand for Metastatic Castration-Resistant Prostate Cancer
On March 23, the U.S. Food and Drug Administration approved lutetium Lu-177 vipivotide tetraxetan (Pluvicto) for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer who have been treated with androgen receptor...
FDA Approves Pembrolizumab for Advanced Endometrial Carcinoma
On March 21, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) as a single agent for patients with advanced endometrial carcinoma that is microsatellite instability–high or mismatch repair–deficient (as determined by an FDA-approved test). Eligible patients have disease...
FDA Approves Nivolumab/Relatlimab-rmbw for Unresectable or Metastatic Melanoma
On March 18, the U.S. Food and Drug Administration (FDA) approved nivolumab and relatlimab-rmbw (Opdualag) for adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. The approved treatment is a fixed-dose combination of the LAG-3–blocking antibody relatlimab ...
FDA Approval in Germline BRCA-Mutated, HER2-Negative, High-Risk Early-Stage Breast Cancer
In this week’s episode, we’ll discuss a recent U.S. Food and Drug Administration (FDA) approval in germline BRCA-mutated, HER2-negative, high-risk early-stage breast cancer. Then, we’ll hear about the publication of final overall survival results from the MONALEESA-2 trial, which evaluated the...
Genitourinary Oncology 2021–2022 Almanac
The past year has witnessed tremendous advances in genitourinary oncology. I am pleased to review these findings in this year’s Genitourinary Oncology Almanac from The ASCO Post. I hope that you will find this roadmap helpful in highlighting a selection of these exciting developments. Checkpoint...
VISION Trial: Novel PSMA-Targeted Radiotherapy Improves Outcomes in Metastatic Prostate Cancer
Lutetium-177–PSMA-617 (LuPSMA)—an investigational radiolabeled small molecule—significantly improved radiographic progression-free survival and overall survival when added to the standard of care compared with the standard of care alone for men with metastatic castration-resistant prostate cancer...
FDA Approves Olaparib for Adjuvant Treatment of High-Risk Early Breast Cancer
On March 11, the U.S. Food and Drug Administration (FDA) approved olaparib (Lynparza) for the adjuvant treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated, HER2-negative, high-risk early breast cancer who have been treated with neoadjuvant or adjuvant...
First FDA Approval for Neoadjuvant Therapy for Early-Stage NSCLC
In this week’s episode, we’ll discuss a recent U.S. Food and Drug Administration (FDA) approval in the early-stage non–small cell lung cancer setting. Then, we’ll hear about a study presented at the 2022 Multidisciplinary Head and Neck Cancers Symposium that investigated methods for the...
New ASCO Report Clarifies Potential Value and Utility of Biosimilars in Oncology
A new report from an ASCO expert panel that addresses unanswered questions about biosimilars—licensed biologic products that are largely analogous to products approved by the U.S. Food and Drug Administration (FDA)—found that they may represent an affordable and effective alternative for cancer...
Importing Oncology Trials From China, or Other Single Foreign Countries, for Consideration of U.S. Regulatory Approvals
In a commentary published recently in The Lancet Oncology,1 Harpreet Singh, MD, and Richard Pazdur, MD, both of the Oncology Center of Excellence at the U.S. Food and Drug Administration (FDA), warned against the increasing number of oncology drug development programs based wholly or predominantly...
Project Confirm: An Initiative to Promote Transparency of the Accelerated Approval Program for Oncology Indications
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, Gautam U. Mehta, MD, Neurosurgical Oncologist and Clinical Reviewer, Division of Oncology 2; Fatima Rizvi,...
Report on COVID-19 Outlines the Pandemic’s Negative Impact on Patient Care and Clinical Research—and the Lessons Learned
Patients with cancer are not only at an increased risk for developing severe COVID-19, but also face cancer treatment delays and interruptions due to the pandemic, potentially worsening cancer outcomes, according to the AACR Report on the Impact of COVID-19 on Cancer Research and Patient Care. In...
Emerging Issues Regarding Artificial Intelligence in Cancer Research and Clinical Practice
Artificial intelligence (AI) has captured society’s imagination and generated enthusiasm for its potential to improve our quality of life, especially in the health-care arena. The availability of high-dimensionality data sets along with innovations in high-performance computing and deep-learning...
President’s Cancer Panel Report: Closing Gaps in Cancer Screening for All Americans
Much progress has been made in the past 50 years since the signing of the National Cancer Act of 1971, which included the establishment of the President’s Cancer Panel. Nevertheless, there remain significant opportunities to make improvements across the cancer spectrum, perhaps none more pressing...
FDA Approves Neoadjuvant Nivolumab and Platinum Doublet Chemotherapy for Early-Stage NSCLC
On March 4, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo) in combination with platinum-doublet chemotherapy for adult patients with resectable non–small cell lung cancer (NSCLC) in the neoadjuvant setting. This represents the first FDA approval for neoadjuvant therapy for...
FDA Clinical Trial Guidances Share Biden Administration’s Goals for Advancing Development of Cancer Treatments
The U.S. Food and Drug Administration (FDA) has issued three final guidances to industry regarding cancer clinical trials that parallel the goals of President Biden’s recently announced effort to renew and build upon his 2016 Cancer Moonshot initiative. Both endeavors aim to facilitate continued...
FDA Approves Pacritinib for Adult Patients With Myelofibrosis and Thrombocytopenia
On February 28, the U.S. Food and Drug Administration (FDA) approved pacritinib (Vonjo) for the treatment of adults with intermediate- or high-risk primary or secondary (post–polycythemia vera or post–essential thrombocythemia) myelofibrosis with a platelet count below 50 × 109/L. Pacritinib is a...
FDA Approves Ciltacabtagene Autoleucel for Relapsed or Refractory Multiple Myeloma
On February 28, the U.S. Food and Drug Administration (FDA) approved ciltacabtagene autoleucel (Carvykti) for the treatment of adults with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 ...
