Search Results
Your search for ,Fda matches 3753 pages
Showing 201 - 250CAR T-Cell Therapy Not Linked to Secondary Cancers, Study Finds
Researchers have found no evidence that chimeric antigen receptor (CAR) T-cell therapy caused secondary cancers in the modified T cells, according to a recent study published by Jadlowsky et al in Nature Medicine. Background CAR T-cell therapy is a personalized type of immunotherapy that employs...
FDA Approves First Companion Diagnostic to Identify Patients With Metastatic Breast Cancer Eligible for T-DXd
The U.S. Food and Drug Administration (FDA) has approved a label expansion for the PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody to identify patients with hormone receptor (HR)-positive, HER2-ultralow metastatic breast cancer who may be eligible for treatment with fam-trastuzumab...
Novel BTK and BCL2 Inhibitors Redefine CLL Treatment Across Front-Line and Relapsed Settings
Two pivotal phase III trials presented at the 2024 American Society of Hematology (ASH) Annual Meeting & Exposition mark a significant shift toward chemotherapy-free approaches in chronic lymphocytic leukemia (CLL), offering potentially more effective and tolerable treatment options for both...
Fecal Microbiota Transplantation Following ASCT
Oral fecal microbiota transplantation may be a feasible and safe option to prevent graft-vs-host disease in patients with hematologic malignancies undergoing allogeneic stem cell transplant (ASCT), according to a recent report published by Reddi et al in Nature Communications. The findings built on ...
FDA Highlights Importance of DPD Deficiency Discussions With Patients Prior to Capecitabine or Fluorouracil Treatment
The U.S. Food and Drug Administration (FDA) has provided a safety announcement to increase awareness of recent updates to the product labeling of capecitabine and fluorouracil related to the risks associated with dihydropyrimidine dehydrogenase (DPD) deficiency. Background Fluoropyrimidines are a...
T-DXd Approved by the FDA for Pretreated Patients With HER2-Low or -Ultralow Metastatic Breast Cancer
The antibody-drug conjugate fam-trastuzumab deruxtecan-nxki (T-DXd) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low (immunohistochemistry [IHC] 1+ or IHC 2+/in situ...
Novel Combination Targeted Therapies, Chemotherapy in BRAF-Mutated Metastatic Colorectal Cancer
First-line treatment with the targeted therapies encorafenib and cetuximab plus a modified leucovorin, fluorouracil, and oxaliplatin (mFOLFOX6) chemotherapy regimen may be effective in patients with BRAF V600E–mutated metastatic colorectal cancer, according to recent findings presented by Kopetz et ...
FDA Approves Datopotamab Deruxtecan-dlnk for Advanced HR-Positive, HER2-Negative Breast Cancer
On January 17, the U.S. Food and Drug Administration (FDA) approved datopotamab deruxtecan-dlnk (Datroway), a TROP-2–directed antibody and topoisomerase inhibitor conjugate, for adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative (IHC 0, IHC1+, or...
FDA Approves Acalabrutinib With Bendamustine and Rituximab for Previously Untreated Mantle Cell Lymphoma
On January 16, the U.S. Food and Drug Administration (FDA) granted traditional approval to the Bruton’s tyrosine kinase inhibitor acalabrutinib (Calquence) with bendamustine and rituximab for adults with previously untreated mantle cell lymphoma who are ineligible for autologous hematopoietic stem...
FDA Approves Sotorasib With Panitumumab for KRAS G12C–Mutated Colorectal Cancer
On January 16, the U.S. Food and Drug Administration (FDA) approved the KRAS G12C inhibitor sotorasib (Lumakras) with the monoclonal antibody panitumumab (Vectibix) for adult patients with KRAS G12C–mutated metastatic colorectal cancer, as determined by an FDA-approved test, who have received prior ...
FDA Proposes Significant Step to Reduce Nicotine Levels in Cigarettes, Tobacco Products
The U.S. Food and Drug Administration (FDA) issued a proposed rule that, if finalized, would make cigarettes and certain other combusted tobacco products minimally or nonaddictive by limiting the level of nicotine in those products. If the rule is finalized, the United States would be the first...
FDA Grants Orphan Drug Designation to New Agent for Pancreatic Neuroendocrine Tumors
The U.S. Food and Drug Administration has granted Orphan Drug designation to the investigational agent ELC-100 for the treatment of pancreatic neuroendocrine tumors, according to a press release from Elicera Therapeutics, the drug developer. ELC-100 is an oncolytic virus–based therapy designed to...
Glucarpidase May Improve Recovery Following Methotrexate-Induced Kidney Toxicity
The drug glucarpidase could serve as an antidote to kidney toxicity in patients receiving the chemotherapy agent methotrexate, according to a recent study published by Gupta et al in Blood. Background As a result of its ability to penetrate the blood-brain barrier, methotrexate is one of the most...
FDA Approves Nivolumab and Hyaluronidase-nvhy for Subcutaneous Injection
On December 27, 2024, the U.S. Food and Drug Administration approved nivolumab and hyaluronidase-nvhy (Opdivo Qvantig) for subcutaneous injection across approved adult, solid tumor nivolumab indications as monotherapy, monotherapy maintenance following completion of nivolumab plus ipilimumab...
FDA Grants Accelerated Approval to Encorafenib Combination for BRAF V600E–Mutant Metastatic Colorectal Cancer
On December 20, 2024, the U.S. Food and Drug Administration granted accelerated approval to encorafenib (Braftovi) in combination with cetuximab and modified fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) for patients with metastatic colorectal cancer with a BRAF V600E mutation, as detected...
Allison Betof Warner, MD, PhD, on TIL Therapy for Advanced Melanoma: Innovative Clinical Advances in Treatment
Allison Betof Warner, MD, PhD, reviews important clinical research in the treatment of advanced melanoma, including tumor-infiltrating lymphocyte (TIL) therapy, the role of this innovative treatment in advanced melanoma, and relevant data, peer-reviewed literature, and FDA approvals in 2024. She...
Mesenchymal Cell Therapy Approved for Steroid-Refractory Acute GVHD
The U.S. Food and Drug Administration (FDA) recently approved remestemcel-L-rknd (Ryoncil), an allogeneic bone marrow–derived mesenchymal stromal cell therapy for steroid-refractory acute graft-vs-host disease (GVHD) in pediatric patients 2 months of age and older. The application received Orphan...
FDA Approves Ensartinib for ALK- Positive Locally Advanced or Metastatic NSCLC
On December 18, 2024, the U.S. Food and Drug Administration (FDA) approved the anaplastic lymphoma kinase (ALK) inhibitor ensartinib (Ensacove) for adults with ALK-positive locally advanced or metastatic non–small cell lung cancer (NSCLC) who have not previously received an ALK inhibitor. For full...
Generic Platinum Chemotherapy Shortages May Not Have Increased Mortality
During a shortage of the generic platinum chemotherapy drugs cisplatin and carboplatin that began in early 2023, investigators found no difference in mortality rates among patients with advanced cancer compared with the previous year, according to a recent study published by Reibel et al in the...
Cosibelimab-ipdl Approved by FDA for Treatment of Metastatic or Locally Advanced Cutaneous Squamous Cell Carcinoma
The U.S. Food and Drug Administration (FDA) approved cosibelimab-ipdl (Unloxcyt), a PD-L1–blocking antibody, for adults with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or radiation therapy. The approval was granted on December 13,...
Accelerated Approval Granted to Zanidatamab-hrii for HER2-Positive Biliary Tract Cancer
The U.S. Food and Drug Administration (FDA) recently 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...
Oral Liquid Imatinib Approved by the FDA in Leukemia
The U.S. Food and Drug Administration (FDA) recently has approved an oral solution of the tyrosine kinase inhibitor, imatinib mesylate, called Imkeldi, to treat certain types of leukemia and other cancers. The new solution is an advanced liquid formulation of imatinib designed to provide dosing...
The Future of Cancer Care, Part 2
The soaring number of cancer survivors since the National Cancer Act of 1971 was enacted into law provides a snapshot of the profound progress made against cancer over the past half-century: 3 million survivors in the 1970s,1 compared to more than 18 million today, and that number is expected to...
FDA Approves Durvalumab for Limited-Stage Small Cell Lung Cancer
On December 4, 2024, the U.S. Food and Drug Administration approved durvalumab (Imfinzi) for adults with limited-stage small cell lung cancer (SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. Efficacy was evaluated in ADRIATIC...
FDA Grants Approval to New Bispecific Antibody for NSCLC and Pancreatic Adenocarcinoma
On December 4, 2024, the U.S. Food and Drug Administration granted accelerated approval to the HER2 × HER3 bispecific antibody zenocutuzumab-zbco (Bizengri) for adults with the following types of lung and pancreatic cancers: advanced, unresectable, or metastatic non–small cell lung cancer (NSCLC)...
In 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...
