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Showing 201 - 250In Treatment of Transplant-Ineligible Myeloma, Addition of Isatuximab Improves Outcomes
In the phase III IMROZ trial, the addition of the anti-CD38 monoclonal antibody isatuximab-irfc to bortezomib, lenalidomide, and dexamethasone (VRd) was more effective than VRd alone as initial therapy in patients ≤ 80 years with newly diagnosed multiple myeloma ineligible for transplant,...
Obecabtagene Autoleucel in Adults With B-Cell ALL
A second-generation chimeric antigen receptor (CAR) T-cell therapy may offer a new option for patients with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL), an aggressive blood cancer with few treatment options. Results from the phase Ib/II FELIX trial, published by Roddie et al in ...
FDA Approves Oral Liquid Imatinib to Treat Patients With Leukemia and Other Cancer Types
The U.S. Food and Drug Administration (FDA) announced the approval of imatinib (Imkeldi) oral solution, the first oral liquid formulation of the drug to treat certain types of leukemias and other cancers. Background In 2024, an estimated 9,280 patients will be diagnosed with chronic myeloid...
How Functional and Genomic Precision Medicine Are Getting Closer to Matching Each Patient to the Right Therapy
Functional precision medicine—in which information is obtained from direct perturbations of tumor-derived living cells that enable immediate translatable, personalized data to guide patient therapy—has its roots dating back more than 50 years.1 However, advances in two- and three-dimensional...
CARMEN-LC03: Tusamitamab Ravtansine vs Docetaxel in Previously Treated Advanced Nonsquamous NSCLC
The multicenter phase III -CARMEN-LC03 trial did not meet its dual primary endpoints of progression-free and overall survival with the CEACAM5-directed antibody-drug conjugate tusamitamab ravtansine vs standard chemotherapy with docetaxel in previously treated patients with advanced nonsquamous...
Penpulimab Combination Therapy for First-Line Treatment of Hepatocellular Carcinoma
The National Medical Products Administration (NMPA) of China has accepted a supplemental new drug application (sNDA) for penpulimab, a differentiated PD-1 monoclonal antibody, in combination with the multikinase inhibitor anlotinib for the first-line treatment of advanced hepatocellular carcinoma...
FDA Grants Accelerated Approval to Zanidatamab-hrii for Previously Treated Unresectable or Metastatic HER2-Positive Biliary Tract Cancer
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to zanidatamab-hrii (Ziihera), a bispecific HER2-directed antibody, for previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer, as detected by an FDA-approved test. The FDA also approved ...
ASH to Present 2024 Honorific Awards at Annual Meeting
The American Society of Hematology (ASH) will recognize exemplary hematologists who have made significant contributions to the field with several honorific awards at the 2024 ASH Annual Meeting and Exposition, being held December 7–10 in San Diego. “ASH is honored to recognize these outstanding...
Project Facilitate: 5 Years of Progress, Outreach, and Service
OCE Insights is 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, Lieutenant Commander Mitchell Chan, PharmD, BCPS, Team Lead and Clinical Analyst, Lieutenant Cameron Wilson, PharmD, BCPS, BCCCP, ...
Is There a Role for Neoadjuvant Chemotherapy in HR-Positive, HER2-Negative Early Breast Cancer?
Question: Based on NATALEE and monarchE data, is there still a need for neoadjuvant chemotherapy in hormone receptor (HR)-positive, HER2-negative early breast cancer? Answer: In monarchE trial, the CDK4/6 inhibitor abemaciclib combined with endocrine therapy demonstrated long-term efficacy in...
AI Tool May Detect Cancer Gene Signatures in Biopsy Images
Researchers have developed an artificial intelligence (AI)-powered computational program that may be capable of predicting the activity of thousands of genes within tumor cells based on standard microscopy images of a biopsy, according to a recent study published by Pizurica et al in Nature...
Immunotherapy Combination for Cutaneous Melanoma
Presurgical treatment with the novel drug vidutolimod and the PD-1 checkpoint inhibitor nivolumab may improve outcomes in patients with stage III cutaneous melanoma, according to a recent study published by Davar et al in Cancer Cell. The findings supported the development of vidutolimod for...
Exploring Issues in Oncofertility
“Cancer in young adults is more complicated in part [because of the risk of] infertility and premature menopause,” commented Ann H. Partridge, MD, MPH, FASCO, Interim Chair, Department of Medical Oncology; the Eric P. Winer, MD Chair in Breast Cancer Research, Dana-Farber Cancer Institute; and ...
FDA Approves Novel Companion Diagnostic Assay
Caris Life Sciences announced that the U.S. Food and Drug Administration (FDA) has approved MI Cancer Seek for use as a companion diagnostic assay to identify patients with cancer who may benefit from targeted therapies. Caris Life Sciences is a next-generation artificial intelligence techbio...
FDA Approves Novel T-Cell Immunotherapy for Adults With Relapsed or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia
The U.S. Food and Drug Administration (FDA) approved the CD19-directed genetically modified autologous T-cell immunotherapy obecabtagene autoleucel (Aucatzyl) for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Efficacy and Safety Efficacy was evaluated in...
TROPION-Lung01 Update: Dato-DXd Shows Activity in Previously Treated Advanced Nonsquamous NSCLC
The novel trophoblast cell-surface antigen 2 (TROP2)-directed antibody-drug conjugate datopotamab deruxtecan (Dato-DXd) vs docetaxel conferred a numerical improvement in overall survival in previously treated patients with advanced non–small cell lung cancer (NSCLC), according to the phase III,...
CARMEN-LC03: Tusamitamab Ravtansine vs Docetaxel in Previously Treated Advanced Nonsquamous NSCLC
The multicenter phase III CARMEN-LC03 trial did not meet its dual primary endpoints of progression-free and overall survival with the CEACAM5-directed antibody-drug conjugate tusamitamab ravtansine vs standard chemotherapy with docetaxel in previously treated patients with advanced nonsquamous...
New Hope for Patients With HER2-Mutant NSCLC: Durable Responses to Two Novel Targeted Therapies
Two novel oral HER2 tyrosine kinase inhibitors have demonstrated promising efficacy in patients with HER2-mutant non–small cell lung cancer (NSCLC), potentially transforming the treatment landscape for this challenging subset of lung cancer cases. According to data presented at the International...
Amivantamab-vmjw Plus Lazertinib Improves Long-Term Outcomes in First-Line Setting of EGFR-Mutant Advanced NSCLC
The combination of the EGFR-MET bispecific antibody amivantamab-vmjw and the EGFR tyrosine kinase inhibitor lazertinib continues to demonstrate superior efficacy compared with the kinase inhibitor osimertinib alone in the first-line treatment of EGFR-mutant advanced non–small cell lung cancer...
Neoadjuvant Therapy Yields Notable Outcomes in Triple-Negative Breast Cancer
The studies summarized below were reported online over the past month in The ASCO Post, generating a high number of visitors. For comprehensive news of these studies and more, visit ASCOPost.com. Triple-Negative Breast Cancer: Phase III KEYNOTE-522 The phase III KEYNOTE-522 trial has...
Study Finds Cisplatin Shortage Led to Treatment Alternatives for Head and Neck Cancer, Significantly Increasing Cost
The alternative use of the monoclonal antibody cetuximab during the shortage of cisplatin in the treatment of head and neck cancer resulted in a 16% total cost increase, leading to a 144-fold increase in costs at the administrative level, impacting payer costs and patient cost-sharing amounts....
Weighing Blood-Based vs Standard Colorectal Cancer Screening Options
Because colonoscopies and more established stool-based tests are more effective at detecting early cancers and precancerous polyps compared with emerging blood-based tests, their long-term impact is projected to be substantially greater than that of blood-based tests, according to a recent study...
FDA Grants Accelerated Approval to Asciminib for Newly Diagnosed Chronic Myeloid Leukemia
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to the BCR::ABL1 kinase inhibitor asciminib (Scemblix) for adult patients with newly diagnosed Philadelphia chromosome–positive chronic myeloid leukemia (Ph-positive CML) in chronic phase. The FDA approval was granted on...
Conversations on Cancer: Exploring Religious Literacy and Spirituality in Cancer Care
OCE Insights is an occasional department 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, the OCE’s Steven Clark Cunningham, MD, MLA, FACS, Clinical Reviewer on the Gastrointestinal Cancers Team, ...
AMA House of Delegates Adopts ASCO-Sponsored Resolutions on Interpretation of Stark Law and Prior Authorization Costs
On September 23, 2024, the U.S. House of Representatives passed the Seniors’ Access to Critical Medications Act of 2024 (H.R. 5526), which would make permanent a waiver put in place during the COVID-19 pandemic that allowed Medicare patients to receive medications dispensed by in-office pharmacies...
CARMEN-LC03: Tusamitamab Ravtansine vs Docetaxel in Previously Treated Advanced Nonsquamous NSCLC
The multicenter phase III CARMEN-LC03 trial did not meet its dual primary endpoints of progression-free and overall survival with the CEACAM5-directed antibody-drug conjugate tusamitamab ravtansine vs standard chemotherapy with docetaxel in previously treated patients with advanced nonsquamous...
New Hope for Patients With HER2-Mutant NSCLC: Durable Responses to Two Novel Targeted Therapies
Two novel oral HER2 tyrosine kinase inhibitors have demonstrated promising efficacy in patients with HER2-mutant non–small cell lung cancer (NSCLC), potentially transforming the treatment landscape for this rare but challenging subset of lung cancer cases. According to data presented at the...
Accelerated Approval for Bladder Cancer Drug to Be Withdrawn After Negative Trial
On October 18, Gilead Sciences announced its plans to voluntarily withdraw the U.S. accelerated approval for sacituzumab govitecan-hziy (Trodelvy) for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing...
FDA Approves Novel Combination for Gastric or Gastroesophageal Junction Adenocarcinoma
On October 18, 2024, the U.S. Food and Drug Administration (FDA) approved zolbetuximab-clzb (Vyloy), a claudin 18.2 (CLDN18.2)-directed cytolytic antibody, with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or...
Tumor Treating Fields Therapy Receives FDA Approval in Metastatic NSCLC
On October 15, 2024, Novocure announced the U.S. Food and Drug Administration (FDA) approval of Optune Lua® for concurrent use with PD-1/PD-L1 inhibitors or docetaxel for the treatment of adults with metastatic non–small cell lung cancer (NSCLC) who have experienced disease progression on or after...
New Directions in ALL, CML, and CLL Treatment
The Society of Hematologic Oncology (SOHO) 2024 Annual Meeting showcased several groundbreaking studies in the field of hematologic oncology, including key findings in childhood acute lymphoblastic leukemia (ALL), chronic myeloid leukemia (CML), and chronic lymphocytic leukemia (CLL). The ASCO...
FDA Approves Inavolisib Combination in PIK3CA-Mutated, HR-Positive, HER2-Negative Advanced Breast Cancer
The U.S. Food and Drug Administration (FDA) approved the PI3K inhibitor inavolisib (Itovebi) with the CDK4/6 inhibitor palbociclib and fulvestrant for adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, HER2-negative, locally advanced or metastatic breast cancer, as...
FDA Approves Perioperative Nivolumab for Resectable NSCLC
On October 3, 2024, the U.S. Food and Drug Administration approved nivolumab (Opdivo) with platinum-doublet chemotherapy as neoadjuvant treatment, followed by single-agent nivolumab after surgery as adjuvant treatment, for adults with resectable (tumors ≥ 4 cm and/or node-positive) non–small cell...
Conversations on Cancer: Exploring Religious Literacy and Spirituality in Cancer Care
OCE Insights is an occasional department 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, the OCE’s Steven Clark Cunningham, MD, MLA, FACS, Clinical Reviewer on the Gastrointestinal Cancers Team, ...
Navigating Uncharted Waters in the Post-Chevron Sea Change
It is not often that the oncology community looks to the Supreme Court to forecast its future. In 2024, two decisions seemingly unrelated to health care were issued that are likely to have a monumental impact on oncology care delivery. The Court’s rulings—on June 28, Loper Bright Enterprises et ...
Amivantamab-vmjw Plus Lazertinib Improves Long-Term Outcomes in First-Line Setting of EGFR-Mutant Advanced NSCLC
The combination of the EGFR-MET bispecific antibody amivantamab-vmjw and the EGFR tyrosine kinase inhibitor lazertinib continues to demonstrate superior efficacy compared with the kinase inhibitor osimertinib alone in the first-line treatment of EGFR-mutant advanced non–small cell lung cancer...
FDA Approves Selpercatinib for RET Fusion–Positive Medullary Thyroid Cancer
On September 27, 2024, the U.S. Food and Drug Administration granted traditional approval to selpercatinib (Retevmo) for adult and pediatric patients aged 2 years and older with advanced or metastatic medullary thyroid cancer with a RET mutation, as detected by an FDA-approved test, who require...
CABINET Trial Supports Multitargeted Tyrosine Kinase Inhibitor for Advanced Neuroendocrine Tumors
As reported in The New England Journal of Medicine by Chan et al, the multicenter phase III CABINET trial has shown significantly improved progression-free survival with the multitargeted tyrosine kinase inhibitor cabozantinib vs a placebo in previously treated patients with progressive, advanced...
FDA Approves Osimertinib in Stage III NSCLC After Chemoradiotherapy
On September 25, the U.S. Food and Drug Administration approved osimertinib (Tagrisso) for adults with locally advanced, unresectable (stage III) non–small cell lung cancer (NSCLC) whose disease has not progressed during or after concurrent or sequential platinum-based chemoradiation therapy. These ...
Cisplatin Shortage Led to Treatment Alternatives for Head and Neck Cancer, Significantly Increasing Cost
The alternative use of the monoclonal antibody cetuximab during the shortage of cisplatin in the treatment of head and neck cancer resulted in a 16% total cost increase, leading to a 144-fold increase in costs at the administrative level, impacting payer costs and patient cost-sharing amounts,...
Adjuvant Pembrolizumab Following Surgery May Improve Cancer-Free Survival in Patients With High-Risk Urothelial Carcinoma
Treatment with the immunotherapy agent pembrolizumab may nearly double the length that patients with high-risk, muscle-invasive urothelial carcinoma are cancer free following surgical removal of the bladder, according to a recent study published by Apolo et al in The New England Journal of...
Black Patients With Triple-Negative Breast Cancer May Be Less Likely to Receive Immunotherapy Compared With White Patients
Black patients with triple-negative breast cancer may receive immunotherapy at lower rates than White patients, according to new findings presented by Freeman et al at the 2024 American Association for Cancer Research (AACR) Conference on the Science of Cancer Health Disparities in Racial/Ethnic...
Isatuximab Plus VRd Approved by FDA for Newly Diagnosed, Transplant-Ineligible Multiple Myeloma
On September 20, the U.S. Food and Drug Administration (FDA) approved the monoclonal antibody isatuximab-irfc (Sarclisa) in combination with bortezomib, lenalidomide, and dexamethasone for adults with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT)....
Phase III CABINET Trial: Cabozantinib in Advanced Neuroendocrine Tumors
Cabozantinib may be effective at improving progression-free survival in patients with previously treated neuroendocrine tumors, according to recent findings presented by Chan et al at the European Society for Medical Oncology (ESMO) Congress 2024 (Abstract 1141O) and simultaneously published in The ...
FDA Approves Amivantamab-vmjw With Carboplatin and Pemetrexed for Non–Small Cell Lung Cancer With EGFR Exon 19 Deletions or L858R Mutations
On September 19, the U.S. Food and Drug Administration (FDA) approved amivantamab-vmjw (Rybrevant) with carboplatin and pemetrexed for adults with locally advanced or metastatic non–small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R...
AACR Cancer Progress Report Features Breakthroughs in Cancer Science and Persistent Inequities in Care
The AACR Cancer Progress Report 2024, released on September 18, showcases the extraordinary progress being made against cancer. The report highlights continuing reductions in mortality, which has fallen by 33% between 1991 and 2021, translating into more than 4 million deaths averted from cancer,...
AEGEAN Update Confirms Benefit of Perioperative Durvalumab in Resectable NSCLC
The second planned interim analysis of the global phase III AEGEAN trial—reported by John V. Heymach, MD, PhD, of The University of Texas MD Anderson Cancer Center, Houston, and colleagues at the International Association for the Study of Lung Cancer (IASLC) 2024 World Conference on Lung Cancer...
FDA Approves Pembrolizumab With Chemotherapy for Unresectable Advanced or Metastatic Malignant Pleural Mesothelioma
On September 17, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) with pemetrexed and platinum chemotherapy as first-line treatment of unresectable advanced or metastatic malignant pleural mesothelioma. Efficacy and Safety Efficacy was investigated in KEYNOTE-483...
FDA Draft Guidance on Conducting Multiregional Oncology Clinical Trials
On September 16, the U.S. Food and Drug Administration (FDA) issued a draft guidance to provide sponsors with recommendations for conducting multiregional clinical trials in support of applications for drugs intended to treat cancer, according to a notice published in the Federal Register....
FDA Seeks Consumer Representatives for the Oncologic Drugs Advisory Committee
The U.S. Food and Drug Administration (FDA) is seeking consumer representatives to serve on the Oncologic Drugs Advisory Committee (ODAC). A consumer representative must be able to analyze scientific data, understand research design, discuss benefits and risks, and evaluate the safety and...
