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Showing 301 - 350Multicultural 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 ...
A Clinical Trial for Bladder Cancer Gave Me Back My Life
About 8 years ago, I was just a few years into menopause when I noticed blood in my urine. It wasn’t accompanied by pain, frequent urination, or any other troubling symptoms, so initially I wasn’t too concerned. But when I started passing pieces of tissue, I became alarmed and made an appointment...
From Fatal to Fearless: How Patients Can Take Control of Their Disease and Fear Cancer Less
In 1996, at the age of 37, Kathy Giusti was diagnosed with the incurable blood cancer multiple myeloma and told she had about 3 years to live. In the mid-1990s, effective therapies for this second most common blood cancer were nearly nonexistent. Standard of care for myeloma consisted of oral...
FDA Approves Safety Labeling Changes Regarding DPD Deficiency for Fluorouracil Injection Products
On March 21, the U.S. Food and Drug Administration (FDA) approved safety labeling changes for fluorouracil injection products. This effort was a collaboration between the FDA’s Office of Generic Drugs and the Oncology Center of Excellence. Fluorouracil injection was initially approved in 1962. The...
Incidence of Secondary T-Cell Malignancies Following CAR T-Cell Therapy
Investigators have found that second primary malignancies following chimeric antigen receptor (CAR) T-cell therapy were reported in 4.3% of CAR T-cell therapy adverse event reports submitted to the U.S. Food and Drug Administration’s (FDA) Adverse Event Reporting System, with T-cell malignancies...
Adjuvant Pembrolizumab: A New Option for High-Risk Muscle-Invasive Urothelial Cancer
Adjuvant use of the PD-1 inhibitor pembrolizumab achieved a statistically significant and clinically meaningful improvement in disease-free survival in patients with high-risk muscle-invasive urothelial carcinoma vs observation after surgical resection, according to an interim analysis of the phase ...
Osimertinib With Chemotherapy for EGFR-Mutated NSCLC
On February 16, 2024, osimertinib (Tagrisso) was approved by the U.S. Food and Drug Administraton (FDA) with pemetrexed and platinum-based chemotherapy for patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) with tumors having EGFR exon 19 deletions or exon 21 L858R...
FDA Grants Accelerated Approval to Ponatinib With Chemotherapy for Newly Diagnosed Philadelphia Chromosome–Positive ALL
On March 19, the U.S. Food and Drug Administration (FDA) granted accelerated approval to the multitarget kinase inhibitor (Iclusig) with chemotherapy for adult patients with newly diagnosed Philadelphia chromosome–positive acute lymphoblastic leukemia (ALL). PhALLCON Efficacy was evaluated in...
Accelerated Approval Granted to First CAR T-Cell Therapy for Relapsed or Refractory CLL/SLL
On March 14, the U.S. Food and Drug Administration (FDA) granted accelerated approval to lisocabtagene maraleucel (Breyanzi), a CD19-directed chimeric antigen receptor (CAR) T-cell therapy, for the treatment of adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small...
FDA Approves Tislelizumab for Previously Treated Patients With Advanced Esophageal Cancer
On March 14, the U.S. Food and Drug Administration (FDA) approved the humanized immunoglobulin G4 anti–PD-1 monoclonal antibody tislelizumab-jsgr (Tevimbra) as monotherapy for adults with unresectable or metastatic esophageal squamous cell carcinoma after prior systemic chemotherapy that did not...
Novel Dual-Target CAR T-Cell Therapy for Recurrent Glioblastoma
Targeting two brain tumor–associated proteins with chimeric antigen receptor (CAR) T-cell therapy may reduce solid tumor growth in patients with recurrent glioblastoma, according to results from a phase I trial published by Bagley et al in Nature Medicine. The findings suggest that the new...
Immunotherapy Trials for Metastatic NSCLC: FDA Pooled Analysis
In a U.S. Food and Drug Administration (FDA) pooled analysis reported in The Lancet Oncology, Bernardo Haddock Lobo Goulart, MD, and colleagues found that response rate and progression-free survival were only moderately correlated with overall survival in first-line immunotherapy trials for...
I Am Young and Fit—and Have Stage IV Alveolar Soft-Part Sarcoma
Except for my right thigh being bigger than my left thigh, there was no hint that I was harboring advanced alveolar soft-part sarcoma when I was diagnosed with the cancer in 2019. I initially chocked up the discrepancy in my legs to the vigorous workouts I had received during my cheerleading days,...
Olaparib Plus Abiraterone and Prednisone Improves Outcomes Over Single Agents in BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer
First-line treatment with the PARP inhibitor olaparib plus the androgen biosynthesis inhibitor abiraterone acetate and the steroid prednisone improved progression-free survival and response rates compared with either treatment alone (ie, olaparib or abiraterone plus prednisone) in patients with...
FDA Grants Accelerated Approval to Zanubrutinib Plus Obinutuzumab for Relapsed or Refractory Follicular Lymphoma
On March 7, the U.S. Food and Drug Administration (FDA) granted accelerated approval to the small-molecule BTK inhibitor zanubrutinib (Brukinsa) in combination with the anti-CD20 monoclonal antibody obinutuzumab for patients with relapsed or refractory follicular lymphoma after two or more lines of ...
FDA Approves Nivolumab in Combination With Cisplatin and Gemcitabine for Unresectable or Metastatic Urothelial Carcinoma
On March 6, the U.S. Food and Drug Administration (FDA) approved the PD-1 inhibitor nivolumab (Opdivo) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma. CheckMate 901 Efficacy was evaluated in CheckMate ...
FDA Approves Inotuzumab Ozogamicin for Pediatric Patients With ALL
On March 6, the U.S. Food and Drug Administration (FDA) approved the CD22-targeted antibody-drug conjugate inotuzumab ozogamicin (Besponsa) for pediatric patients aged 1 year and older with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL). Study WI203581...
FDA Approves Denosumab Biosimilars
On March 5, the the U.S. Food and Drug Administration (FDA) approved Jubbonti (denosumab-bbdz, 60 mg/1 mL injection), as an interchangeable biosimilar to U.S.-licensed Prolia (denosumab), and Wyost (denosumab-bbdz, 120 mg/1.7 mL [70 mg/mL] injection), as an interchangeable biosimilar to...
FDA Approves Amivantamab-vmjw for EGFR Exon 20 Insertion–Mutated NSCLC
On March 1, the FDA approved the monoclonal bispecific anti–EGFR-MET antibody amivantamab-vmjw (Rybrevant) in combination with carboplatin and pemetrexed for the first-line treatment of locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test....
Rapid Guideline Update on Radiotracers for Determining Radioligand Treatment Eligibility in Metastatic Castration-Resistant Prostate Cancer
ASCO has released a guideline rapid recommendation update addressing radiotracers used for prostate-specific membrane antigen (PSMA) positron-emission tomography (PET) diagnostic imaging for selecting patients with metastatic castration-resistant prostate cancer (mCRPC) to receive...
FDA Approves Biweekly Teclistamab Dosing Regimen for Patients With Multiple Myeloma
On February 20, the U.S. Food and Drug Administration (FDA) approved the supplemental biologics license application for teclistamab-cqyv (Tecvayli) for a reduced dosing frequency of 1.5 mg/kg every 2 weeks in patients with relapsed or refractory multiple myeloma who have achieved and maintained a...
FDA Approves Osimertinib With Chemotherapy for EGFR-Mutated NSCLC
On February 16, the U.S. Food and Drug Administration (FDA) approved osimertinib (Tagrisso) with platinum-based chemotherapy for patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an...
FDA Grants Accelerated Approval to Lifileucel for Unresectable or Metastatic Melanoma
On February 16, the U.S. Food and Drug Administration (FDA) granted accelerated approval to lifileucel (Amtagvi), a tumor-derived autologous T-cell immunotherapy, for adult patients with unresectable or metastatic melanoma who were previously treated with a PD-1 blocking antibody, or, if they have...
FDA Approves Tepotinib for Metastatic NSCLC
On February 15, the U.S. Food and Drug Administration (FDA) granted traditional approval to the kinase inhibitor tepotinib (Tepmetko) for adult patients with metastatic non–small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14–skipping alterations. The agent is...
Steven A. Rosenberg, MD, PhD, Honored With 2024 AACR Award for Lifetime Achievement in Cancer Research
The American Association for Cancer Research (AACR) will award Steven A. Rosenberg, MD, PhD, Fellow of the AACR Academy, with the 2024 AACR Award for Lifetime Achievement in Cancer Research during the AACR Annual Meeting, to be held April 5–10 in San Diego. His award lecture will be presented on...
FDA Approves Irinotecan Liposome as First-Line Treatment of Metastatic Pancreatic Adenocarcinoma
On February 13, the U.S. Food and Drug Administration (FDA) approved irinotecan liposome (Onivyde) with oxaliplatin, fluorouracil, and leucovorin for the first-line treatment of metastatic pancreatic adenocarcinoma. NAPOLI-3 Efficacy was evaluated in NAPOLI-3 (ClinicalTrials.gov identifier...
