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Showing 251 - 300CARMEN-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Accelerated Approval for Bladder Cancer Drug to Be Withdrawn After Negative Trial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...
FDA Approves Atezolizumab and Hyaluronidase-tqjs for Subcutaneous Injection
The U.S. Food and Drug Administration (FDA) approved atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza) for subcutaneous injection for all the adult indications as the intravenous formulation of atezolizumab (Tecentriq), including non–small cell lung cancer (NSCLC), small cell lung cancer...
Risk of Secondary Cancers After CAR T-Cell Therapy Similar to Previous Standard-of-Care Treatments, Study Finds
Although chimeric antigen receptor (CAR) T-cell therapy has transformed treatment for patients with relapsed and refractory blood cancers, it can also cause an array of immune-related adverse events, including cytokine-release syndrome, immune effector cell–associated neurotoxicity syndrome, and...
Youth E-Cigarette Use May Have Declined to Lowest Level in a Decade
A fewer number of U.S. youths have reported current use of e-cigarettes in 2024 compared with 2023, according to new findings published by Park-Lee et al in the Morbidity and Mortality Weekly Report. Background E-cigarettes and nicotine pouches are two categories of tobacco products the U.S. Food...
FDA Approves Ready-to-Use Version of Bortezomib for Subcutaneous Administration
The U.S. Food and Drug Administration (FDA) has approved a new presentation of bortezomib (Boruzu) for ready-to-use subcutaneous or intravenous administration. This new ready-to-use oncology product reduces the compounding preparation steps typically required with administration. Bortezomib, a...
Too Much, Too Little, Just Right: Optimizing Cancer Care for Older Adults
Imagine walking into a fancy restaurant only to find a menu consisting mostly of kids’ dishes. It would make no sense. Just 25% of restaurant diners are younger than age 12, and they rarely write Yelp reviews. But when it comes to cancer treatment, this is not very far from what we do. The median...
A Diagnosis of Triple-Negative Breast Cancer Was Not on My Radar
Despite the fact that there is no history of breast cancer in my family, I didn’t take that good fortune for granted and was diligent about getting my regularly scheduled mammograms and clinical breast exams, which never found any hint of disease. So, it was especially frightening when, while on a...
Delays in Oral Antimyeloma Treatment Initiation: Role of Social Determinants of Health
A retrospective cohort study published in Blood Cancer Journal by Gasoyan et al revealed discrepancies between the timing of the initiation of any treatment and the fill of prescriptions for oral antimyeloma medications in patients with multiple myeloma, with a lower likelihood of Black and older...
FDA Approves Cancer Biomarker Test, Companion Diagnostic Indications
The U.S. Food and Drug Administration (FDA) has approved the in vitro diagnostic TruSight Oncology (TSO) Comprehensive test and its first two companion diagnostic indications. This targeted sequencing panel interrogates over 500 genes to profile a patient's solid tumor, helping to increase the...
FDA Approves Lazertinib With Amivantamab-vmjw for EGFR-Mutated NSCLC
The U.S. Food and Drug Administration (FDA) has approved the EGFR inhibitor lazertinib (Lazcluze) in combination with the EGFR/MET-targeting bispecific antibody amivantamab-vmjw (Rybrevant) for the first-line treatment of patients with locally advanced or metastatic non–small cell lung cancer...
SCOTUS Ruling Upends Country’s Regulatory Framework, Threatens to Complicate and Delay Health-Care Delivery
The Association for Clinical Oncology (ASCO) has serious concerns about the impact of the Supreme Court’s rulings in Loper Bright Enterprises v Raimondo and Relentless, Inc. v Department of Commerce on cancer care. These decisions overturned the “Chevron deference” or “Chevron doctrine,” a legal...
New Modeling Data Show Effective Detection and Health-Care Savings Associated With the Multitarget Stool DNA Test
New modeling data have been released that describe the projected impact of the first and only multitarget stool DNA test (marketed as Cologuard) on patients, health-care professionals, and the U.S. health-care system since its U.S. Food and Drug Administration (FDA) approval 10 years ago. About the ...
FDA OCE Invites Pediatric Cancer Advocates to Meet on October 15
The U.S. Food and Drug Administration’s Oncology Center of Excellence (OCE) Pediatric Oncology Program invites members of the pediatric cancer advocacy community to participate in the 2024 OCE Pediatric Advocacy Forum on October 15. The purpose of this event is to strengthen collaboration and...
FDA Approves Neoadjuvant/Adjuvant Durvalumab for Resectable NSCLC
The U.S. Food and Drug Administration (FDA) has approved the PD-L1 inhibitor durvalumab (Imfinzi) with platinum-containing chemotherapy as neoadjuvant treatment followed by single-agent durvalumab as adjuvant treatment after surgery for adults with resectable (tumors ≥ 4 cm and/or node positive)...
FDA Approves Axatilimab-csfr for Chronic GVHD
On August 14, the U.S. Food and Drug Administration (FDA) approved axatilimab-csfr (Niktimvo), a colony-stimulating factor–1 receptor–blocking antibody, for the treatment of chronic graft-vs-host disease (GVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric...
FDA Approves Immunotherapy for Relapsed or Refractory CTCL
On August 8, the U.S. Food and Drug Administration (FDA) approved denileukin diftitox-cxdl (Lymphir), a novel immunotherapy for the treatment of adult patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL) who have received at least one prior systemic therapy. Denileukin diftitox is...
FDA Approves IDH1/2 Inhibitor for Certain Patients With Astrocytoma or Oligodendroglioma
The U.S. Food and Drug Administration (FDA) has approved vorasidenib (Voranigo), an isocitrate dehydrogenase-1 (IDH1) and -2 (IDH2) inhibitor, for adult and pediatric patients aged 12 years and older with grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation, following...
FDA Grants Accelerated Approval to T-Cell Therapy for Unresectable or Metastatic Synovial Sarcoma
On August 2, the U.S. Food and Drug Administration (FDA) granted accelerated approval to afamitresgene autoleucel (Tecelra), a melanoma-associated antigen A4 (MAGE-A4)-directed genetically modified autologous T-cell immunotherapy, for adults with unresectable or metastatic synovial sarcoma who have ...
FDA Expands Endometrial Cancer Indication for Dostarlimab-gxly With Chemotherapy
On August 1, the U.S. Food and Drug Administration (FDA) approved dostarlimab-gxly (Jemperli) with carboplatin and paclitaxel, followed by single-agent dostarlimab, for adults with primary advanced or recurrent endometrial cancer. Dostarlimab was previously approved in July 2023 with carboplatin...
FDA Approves Daratumumab and Hyaluronidase-fihj With VRd for Multiple Myeloma
On July 30, the U.S. Food and Drug Administration (FDA) approved daratumumab and hyaluronidase-fihj (Darzalex Faspro) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for induction and consolidation in patients with newly diagnosed multiple myeloma who are eligible for...
Guardant Health’s Shield Blood Test Approved by the FDA as a Primary Screening Option for Colorectal Cancer
On July 29, the U.S. Food and Drug Administration (FDA) approved Guardant Health’s Shield blood test for colorectal cancer screening in adults aged 45 years and older who are at average risk for the disease. It is the first blood test to be approved by the FDA as a primary screening option for...
Phase II Study Shows Activity for Novel Targeted Agent in KRAS G12C–Mutated NSCLC
The oral KRAS G12C inhibitor glecirasib has emerged as a therapeutic option for previously treated KRAS G12C–mutated non–small cell lung cancer (NSCLC). It may potentially improve efficacy and tolerability compared with current U.S. Food and Drug Administration–approved agents, according to data...
Amivantamab-vmjw in NSCLC With EGFR Exon 20 Insertion Mutations
On March 1, 2024, amivantamab-vmjw (Rybrevant) was approved for use with carboplatin and pemetrexed for first-line treatment of locally advanced or metastatic non–small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, as detected by a U.S. Food and Drug Administration...
Two Phase III Trials Report Benefit With Isatuximab-Based Regimens in Newly Diagnosed Multiple Myeloma
In newly diagnosed, transplant-ineligible patients with multiple myeloma, treatment with the anti-CD38 monoclonal antibody isatuximab plus bortezomib, lenalidomide, and dexamethasone (VRd) led to a 40% reduction in the risk of disease progression or death and “deep and sustained responses,” almost...
Multiple Myeloma: Using Absolute Lymphocyte Count to Predict Outcomes After CAR T-Cell Therapy
A simple blood test that measures lymphocyte counts may predict whether patients with relapsed multiple myeloma are going to respond well to chimeric antigen receptor (CAR) T-cell immunotherapy, according to research published by Saldarriaga et al in Blood Advances. The study found that patients...
Shortening FDA-Mandated CAR T-Cell Therapy Monitoring Periods Could Improve Access to Treatment in Patients With DLBCL
Two hallmark toxicities of chimeric antigen receptor (CAR) T-cell therapy may be rare after 2 weeks following infusion in patients with diffuse large B-cell lymphoma (DLBCL), supporting a shorter, more flexible toxicity monitoring period., according to a recent study published by Ahmed et al in...
