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Showing 301 - 350AACR, 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ASCO, Friends of Cancer Research Applaud FDA Draft Guidance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...
Multicultural ASCO President-Elect Was Raised in Mexico by Parents Who Instilled a Sense of Duty to Make a Difference
ASCO President-Elect Eric J. Small, MD, FASCO, developed much of his multicultural world view during his childhood in Mexico City. “My parents were expatriates who moved to Mexico in the 1950s and settled there. I was born in Mexico City and grew up bilingually. I went to an English-Spanish...
FDA Grants Accelerated Approval to Selpercatinib for Pediatric Patients With RET-Altered Metastatic Thyroid Cancer or Other Solid Tumors
On May 29, the U.S. Food and Drug Administration (FDA) granted accelerated approval to the RET inhibitor selpercatinib (Retevmo) for pediatric patients aged 2 years and older with the following: Advanced or metastatic medullary thyroid cancer with a RET mutation, as detected by an FDA-approved...
Patient Characteristics May Impact Results of AI Algorithm–Interpreted Screening Mammograms
Investigators have found that patient characteristics such as age and race may influence false-positive results from artificial intelligence (AI)-interpreted screening mammograms, according to a recent study published by Nguyen et al in Radiology. Background Although preliminary data suggested that ...
FDA Withdraws Approval of Cholangiocarcinoma Drug Indication for FGFR Inhibitor
On May 16, the U.S. Food and Drug Administration (FDA) announced the final withdrawal of the approval of infigratinib (Truseltiq) for previously treated patients with unresectable, locally advanced, or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other...
Outcomes for Cancer Drugs Initially FDA-Approved With Immature Overall Survival Data
In a study reported in The Lancet Oncology, Naci et al identified the degree to which initial U.S. Food and Drug Administration (FDA) approvals of cancer drugs based on immature overall survival data were subsequently followed by reporting of overall survival results. Study Details The study...
NCCN Clinical Practice Guidelines in Oncology: 2024 Updates
The National Comprehensive Cancer Network® published its first set of Clinical Practice Guidelines in Oncology (NCCN Guidelines®) in 1996, covering eight tumor types. Currently, guidelines are available for more than 60 tumor types, subtypes, and related topics. The NCCN’s 29th Annual Conference...
FDA Grants Accelerated Approval to Tarlatamab-dlle for Extensive-Stage SCLC
On May 16, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tarlatamab-dlle (Imdelltra), a bispecific T-cell engager immunotherapy targeting delta-like ligand 3 and CD3, for patients with extensive-stage small cell lung cancer (SCLC) with disease progression on or after...
FDA Grants Accelerated Approval to Lisocabtagene Maraleucel for Relapsed or Refractory Follicular Lymphoma
On May 15, the U.S. Food and Drug Administration (FDA) granted accelerated approval to the chimeric antigen receptor (CAR) T-cell therapy lisocabtagene maraleucel (Breyanzi) for adult patients with relapsed or refractory follicular lymphoma who have received two or more prior lines of systemic...
FDA Approves HPV Self-Collection Solution
On May 15, Roche announced the U.S. Food and Drug Administration (FDA) approval of its human papillomavirus (HPV) self-collection solution—one of the first of such tests available in the United States. Screening for HPV can help identify women who are at risk of developing cervical cancer so that...
Breast Implant–Related Cancers: Should Our Patients Be Concerned?
The U.S. Food and Drug Administration (FDA) issued a safety communication,1 which was updated2 on March 22, 2023, informing the public that there have been reports of squamous cell carcinomas (SCC) and various lymphomas of the breast in the capsule or scar of breast implants. These lymphomas are ...
FDA Approves Trastuzumab Biosimilar Trastuzumab-strf
The U.S. Food and Drug Administration (FDA) has approved trastuzumab-strf (Hercessi), a biosimilar to trastuzumab (Herceptin), for the treatment of HER2-overexpressing breast cancer and gastric or gastroesophageal junction adenocarcinoma. Trastuzumab-strf is indicated for adjuvant treatment of...
FDA Approves Tisotumab Vedotin-tftv for Recurrent or Metastatic Cervical Cancer
On April 29, the U.S. Food and Drug Administration (FDA) granted traditional approval to tisotumab vedotin-tftv (Tivdak) for patients with recurrent or metastatic cervical cancer whose disease progressed on or after chemotherapy. Tisotumab vedotin-tftv previously received accelerated approval for...
Rapid Guideline Update Supports Capivasertib for Hormone Receptor–Positive, HER2-Negative Metastatic Breast Cancer
Patients with estrogen receptor–positive, HER2-negative metastatic breast cancer now have a new medication option that extends survival, according to an ASCO rapid guideline update.1 The update was designed to orient clinicians to outcomes from the CAPItello-291 trial, which led to the U.S. Food...
Imaging Drug to Assist in Detection of Cancerous Tissue Following Lumpectomy Approved
Recently, the U.S. Food and Drug Administration (FDA) approved pegulicianine (Lumisight) for adult patients with breast cancer to assist in the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy. Pegulicianine is a...
FDA Approves Lu-177 Dotatate for Pediatric Patients With GEP-NETs
On April 23, the U.S. Food and Drug Administration (FDA) approved lutetium Lu-177 dotatate (Lutathera) for pediatric patients aged 12 years and older with somatostatin receptor (SSTR)-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut...
FDA Grants Accelerated Approval to Tovorafenib for Patients With Relapsed or Refractory BRAF-Altered Pediatric Low-Grade Glioma
On April 23, the U.S. Food and Drug Administration (FDA) granted accelerated approval to the type II RAF inhibitor tovorafenib (Ojemda) for patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma harboring a BRAF fusion or rearrangement or BRAF V600 mutation. This...
FDA Approves Nogapendekin Alfa Inbakicept-pmln for BCG-Unresponsive Non–Muscle Invasive Bladder Cancer
On April 22, the U.S. Food and Drug Administration (FDA) approved nogapendekin alfa inbakicept-pmln (Anktiva) with bacillus Calmette-Guérin (BCG) for adults with BCG-unresponsive non–muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors. QUILT-3.032 Trial Efficacy...
Alectinib Approved as Adjuvant Treatment for ALK-Positive Non–Small Cell Lung Cancer
On April 18, the U.S. Food and Drug Administration (FDA) approved the tyrosine kinase inhibitor alectinib (Alecensa) for adjuvant treatment after tumor resection in patients with ALK-positive non–small cell lung cancer (NSCLC), as detected by an FDA-approved test. Alectinib is an orally...
Adagrasib Plus Cetuximab in KRAS G12C–Mutated Colorectal Cancer
The combination of the KRAS G12C inhibitor adagrasib and the anti-EGFR antibody cetuximab showed clinical activity and promising survival outcomes in a cohort of patients with metastatic, heavily pretreated, KRAS G12C–mutated colorectal cancer, according to results from the phase I/II KRYSTAL-1...
Ciltacabtagene Autoleucel and Idecabtagene Vicleucel Approved by the FDA for Pretreated Patients With Multiple Myeloma
On April 5, the U.S. Food and Drug Administration (FDA) approved ciltacabtagene autoleucel (Carvykti) for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and...
FDA Grants Accelerated Approval to Fam-Trastuzumab Deruxtecan-nxki for Unresectable or Metastatic HER2-Positive Solid Tumors
On April 5, the U.S. Food and Drug Administration (FDA) granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu) for adult patients with unresectable or metastatic HER2-positive (immunohistochemistry [IHC] 3+) solid tumors who have received prior systemic treatment and have no...
Fewer Than Half of Drugs Granted Accelerated Approval Demonstrated Benefit Within 5 Years
In 1992, the U.S. Food and Drug Administration (FDA) instituted its Accelerated Approval regulations, which allow drugs that treat serious conditions and fill an unmet need to be approved early based on a surrogate endpoint. However, any drug approved under this pathway is still required to undergo ...
Danicopan Approved as Add-On Therapy to Ravulizumab or Eculizumab for Extravascular Hemolysis in Adults With Paroxysmal Nocturnal Hemoglobinuria
On April 1, danicopan (Voydeya) was approved by the U.S. Food and Drug Administration (FDA) as add-on therapy to ravulizumab-cwvz or eculizumab for the treatment of extravascular hemolysis (EVH) in adults with paroxysmal nocturnal hemoglobinuria (PNH). VOYDEYA is a first-in-class, oral, Factor D...
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 (FDA)-approved...
FDA Approves Mirvetuximab Soravtansine-gynx for FRα-Positive, Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
On March 22, the U.S. Food and Drug Administration (FDA) approved mirvetuximab soravtansine-gynx (Elahere) for adult patients with folate receptor–alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic ...
