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Showing 251 - 300FDA 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...
AACR, ASA, FDA Outline Considerations for Overall Survival Analyses in Clinical Trials
Experts from the American Association for Cancer Research (AACR), American Statistical Association (ASA), and U.S. Food and Drug Administration (FDA) have outlined considerations for clinical trial designs to enhance the collection and analysis of overall survival data in the context of modern-day...
Chronic Graft-vs-Host Disease: Clinical Trial Updates
Chronic graft-vs-host disease, an immune-mediated disorder that follows allogeneic hematopoietic cell transplantation (allo-HCT), is characterized by debilitating tissue injury with inflammatory and fibrotic pathology leading to significant morbidity and mortality. Historically, the treatment of...
Exploring Health-Care Provider Attitudes Toward HPV Self-Collection Testing
Investigators found that more than 50% of health-care providers surveyed might offer human papillomavirus (HPV) self-collection testing to their patients if the U.S. Food and Drug Administration (FDA) approved the procedure, according to a recent study published by Fontenot et al in Women’s Health...
ASCO: 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...
ASCO, Friends of Cancer Research Applaud FDA Draft Guidance
The Association for Clinical Oncology (ASCO) and Friends of Cancer Research (Friends) are applauding efforts by the U.S. Food and Drug Administration (FDA) to broaden eligibility criteria for cancer clinical trials in order to include more diverse patient populations. In joint comments submitted on ...
Second-Line Therapy With Adagrasib in KRAS G12C–Mutated Non–Small Cell Lung Cancer
Second-line therapy with the KRAS inhibitor adagrasib modestly improved progression-free survival and objective response rate over docetaxel in previously treated patients with advanced KRAS G12C–mutated non–small cell lung cancer (NSCLC), according to the primary analysis of the phase III...
FDA Grants Accelerated Approval to Epcoritamab-bysp for Relapsed or Refractory Follicular Lymphoma
On June 26, the U.S. Food and Drug Administration (FDA) granted accelerated approval to epcoritamab-bysp (Epkinly), a bispecific CD20-directed CD3 T-cell engager, for adult patients with relapsed or refractory follicular lymphoma who have received two or more lines of systemic therapy. EPCORE ...
Tovorafenib in Relapsed or Refractory BRAF-Altered Pediatric Low-Grade Glioma
On April 23, 2024, tovorafenib (Ojemda) was granted accelerated approval by the U.S. Food and Drug Administration (FDA) for patients aged 6 months and older who have relapsed or refractory pediatric low-grade glioma harboring a BRAF fusion or rearrangement or BRAF V600 mutation.1 Tovorafenib is a...
Accelerating Progress in Melanoma and Cancer Research
The Melanoma Research Alliance is on a mission to cure and prevent melanoma, a skin cancer that is diagnosed in more than 100,000 people each year and is expected to take the lives of more than 8,000 individuals in 2024.1 We invite stakeholders across all fields, including medicine, science, and...
Study Finds Fewer Than Half of Accelerated Approval Drugs Show Benefit in Overall Survival or Quality of Life Within 5 Years
In 1992, the U.S. Food and Drug Administration (FDA) instituted the Accelerated Approval regulations, which allow drugs that treat serious conditions, including cancer, and fill an unmet need to be approved early based on a surrogate endpoint.1 However, any drug approved under this pathway is still ...
Adjuvant Use of Alectinib in ALK-Positive NSCLC
On April 18, 2024, the ALK inhibitor alectinib was approved by the U.S. Food and Drug Administration (FDA) for adjuvant treatment after tumor resection in patients with ALK-positive non–small cell lung cancer (NSCLC), as detected by an FDA-approved test.1 Supporting Efficacy Data Approval was based ...
FDA Grants Accelerated Approval to Adagrasib With Cetuximab for KRAS G12C–Mutated Colorectal Cancer
On June 21, the U.S. Food and Drug Administration (FDA) granted accelerated approval to the KRAS G12C inhibitor adagrasib (Krazati) plus cetuximab for adults with KRAS G12C–mutated locally advanced or metastatic colorectal cancer, as determined by an FDA-approved test, who have received prior...
Phase I Study in NHL: Use of ‘Armored’ CAR T Cells May Be Feasible After Standard CAR T-Cell Failure
A novel “armored” chimeric antigen receptor (CAR) T cell appears to be feasible for retreatment of patients with non-Hodgkin lymphoma (NHL) who fail to respond to standard CAR T-cell therapy, according to preliminary results of a phase I trial presented at the 2024 ASCO Annual Meeting.1 The unique...
Radioligand Therapy May Improve Radiographic Progression–Free Survival in Taxane-Naive Patients With Advanced Prostate Cancer
Lutetium (Lu)-177–PSMA-617 radioligand therapy may offer a statistically significant and clinically meaningful radiographic progression-free survival benefit in patients with taxane-naive metastatic castration-resistant prostate cancer, according to findings presented by Herrmann et al at the 2024...
FDA Approves Blinatumomab as Consolidation for CD19-Positive, Ph-Negative B-Cell Precursor ALL
On June 14, 2024, the U.S. Food and Drug Administration (FDA) approved blinatumomab (Blincyto) for adult and pediatric patients aged 1 month and older with CD19-positive, Philadelphia chromosome (Ph)-negative B-cell precursor acute lymphoblastic leukemia (ALL) in the consolidation phase of...
FDA Approves Two Immunochemotherapy Combinations for Endometrial Cancer
On June 17, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) in combination with carboplatin and paclitaxel followed by single-agent pembrolizumab for adult patients with primary advanced or recurrent endometrial carcinoma; on June 14, the agency approved durvalumab...
FDA Grants Accelerated Approval to Repotrectinib for NTRK Fusion–Positive Solid Tumors
On June 13, the U.S. Food and Drug Administration (FDA) granted accelerated approval to repotrectinib (Augtyro) for adult and pediatric patients aged 12 years and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, are locally advanced or metastatic or...
FDA Approves Selpercatinib for RET Fusion–Positive Thyroid Cancer
On June 12, the U.S. Food and Drug Administration (FDA) granted traditional approval to selpercatinib (Retevmo) for adult and pediatric patients aged 2 years and older with advanced or metastatic RET fusion–positive thyroid cancer who require systemic therapy and whose disease is radioactive...
Guideline Update Seeks to Aid Clinicians in the Selection of Systemic Treatments for Advanced Hepatocellular Carcinoma
An ASCO guideline update offers new recommendations on systemic treatment for advanced hepatocellular carcinoma (HCC), based on promising findings from several recent randomized controlled trials as well as the approval of new first- and second-line immunotherapy combinations.1 “This guideline...
FDA’s Oncology Center of Excellence Launches Project 5 in 5, a Crowdsourcing Initiative
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 Cunningham, MD, MLA, FACS, Clinical Reviewer on the Gastrointestinal Cancers Team,...
Nogapendekin Alfa Inbakicept-pmln for BCG-Unresponsive Non–Muscle-Invasive Bladder Cancer
On April 22, 2024, the interleukin-15 receptor agonist nogapendekin alfa inbakicept-pmln was approved for use with bacillus Calmette-Guérin (BCG) for adults with BCG-unresponsive non–muscle-invasive bladder cancer with carcinoma in situ with or without papillary tumors.1 Supporting Efficacy Data...
FDA Approves Imetelstat for Patients With Low- to Intermediate-1 Risk MDS and Transfusion-Dependent Anemia
On June 6, 2024, the U.S. Food and Drug Administration (FDA) approved imetelstat (Rytelo), an oligonucleotide telomerase inhibitor, for adults with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia requiring four or more red blood cell units over 8 weeks...
FDA Approves Lisocabtagene Maraleucel for Relapsed or Refractory Mantle Cell Lymphoma
On May 30, the U.S. Food and Drug Administration (FDA) approved the chimeric antigen receptor (CAR) T-cell therapy lisocabtagene maraleucel (Breyanzi) for adult patients with relapsed or refractory mantle cell lymphoma who have received at least two prior lines of systemic therapy, including a...
Born in a Small Village in India, a Breast Cancer Expert Assumes a Leadership Role in Oncology in Cleveland and Beyond
Jame Abraham, MD, FACP, was born and reared in Kerala, a tropical state in southwestern India. Situated on the Malabar Coast, Kerala was named as one of the ten paradises of the world by National Geographic Traveler. “Along with its natural beauty, Kerala is a true melting pot. Over centuries,...
FDA’s Crowdsourcing Initiative to Benefit Patient-Centric Clinical Trial Innovation
The U.S. Food and Drug Administration’s (FDA) Oncology Center of Excellence (OCE) recently announced a new initiative called “Project 5 in 5.” Project 5 in 5 is a crowdsourcing initiative to ultimately identify five clinically relevant questions that can be answered through use of pragmatic...
