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Showing 451 - 500Is Zanubrutinib Poised to Become a New Standard of Care in Relapsed or Refractory CLL and SLL?
The next-generation Bruton’s tyrosine kinase (BTK) inhibitor zanubrutinib demonstrated superior progression-free survival compared with ibrutinib, with an improved cardiac safety profile, in the first head-to-head comparison between these two BTK inhibitors in relapsed or refractory chronic...
Blinatumomab Improves Survival in MRD-Negative, B-Cell ALL
The standard of care could be changing for adults with newly diagnosed BCR-ABL–negative B-lineage acute lymphoblastic leukemia (ALL) who achieve measurable residual disease (MRD) negativity after induction chemotherapy. In the phase III E1910 trial by the ECOG-ACRIN Cancer Research Group, an...
MAGNOLIA Trial: Zanubrutinib Yields High Response Rates With Low Rate of Cardiac Events in Marginal Zone Lymphoma
Zanubrutinib—a next-generation Bruton’s tyrosine kinase (BTK) inhibitor—achieved high response rates and durable disease control with a low incidence of cardiac effects in patients with relapsed or refractory marginal zone lymphoma, according to updated findings from the final analysis of the phase ...
Hematologic Oncology 2023 Almanac
The past several months have brought significant advances within the field of hematologic oncology. Here we will review some key updates focusing on pivotal clinical trials and new drug approvals. Advances in Lymphoma Presented at the 2023 ASCO Annual Meeting, SWOG S1826 compared nivolumab plus...
FDA Approves Niraparib and Abiraterone Acetate Plus Prednisone for BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer
On August 11, the U.S. Food and Drug Administration (FDA) approved the fixed-dose combination of niraparib and abiraterone acetate (Akeega), with prednisone, for adult patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer, as determined by...
FDA Approves Pralsetinib for RET Fusion–Positive NSCLC
On August 9, the U.S. Food and Drug Administration (FDA) granted regular approval to pralsetinib (Gavreto) for adults with metastatic RET fusion–positive non–small cell lung cancer (NSCLC), as detected by an FDA-approved test. ARROW Trial Pralsetinib was previously granted accelerated approval for...
FDA Grants Accelerated Approval to Talquetamab-tgvs for Treatment of Relapsed or Refractory Multiple Myeloma
On August 9, the U.S. Food and Drug Administration (FDA) granted accelerated approval to the bispecific antibody talquetamab-tgvs (Talvey) for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy (including a proteasome inhibitor, an...
CAR T-Cell Therapies: Trends and Indications
The ASCO Post is pleased to present Hematology Expert Review, an ongoing feature that quizzes readers on issues in hematology. With this installment, we launch a new series of articles on commercially available chimeric antigen receptor (CAR) T-cell therapies. Syed Ali Abutalib, MD, and Jennifer N. ...
Camrelizumab Plus Rivoceranib vs Sorafenib in Unresectable Hepatocellular Carcinoma
In a largely Asian phase III study (CARES-310) reported in The Lancet, Qin et al found that the combination of camrelizumab and rivoceranib (also known as apatinib) significantly prolonged progression-free and overall survival vs sorafenib in the first-line treatment of unresectable or metastatic...
FDA Approves Trifluridine and Tipiracil With Bevacizumab for Previously Treated Metastatic Colorectal Cancer
On August 2, the U.S. Food and Drug Administration (FDA) approved trifluridine and tipiracil (Lonsurf) with bevacizumab for patients with metastatic colorectal cancer previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and, if ...
Noninvasive Multitarget Stool DNA Methylation Assay in the Early Detection of Multiple Gastrointestinal Cancers
With an estimated 4.8 million new cases and 3.4 million deaths worldwide recorded in 2018, cancers of the gastrointestinal tract account for over one-quarter (26%) of global cancer incidence and over one-third (35%) of all cancer-related deaths. Although the U.S. Food and Drug Administration (FDA)...
FDA Approves Dostarlimab-gxly Plus Chemotherapy for dMMR or MSI-H Endometrial Cancer
On July 31, the U.S. Food and Drug Administration (FDA) approved dostarlimab-gxly (Jemperli) with carboplatin and paclitaxel followed by single-agent dostarlimab for patients with primary advanced or recurrent endometrial cancer that is mismatch repair–deficient (dMMR), as determined by an...
Congress Sends ASCO-ASTRO–Supported Letter on Cancer Drug Shortages to the HHS and the FDA
As chemotherapy drug shortages continue to delay patient care and alter treatment plans, 70 bipartisan members of Congress sent a letter to the Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) asking for more information on the shortages and for ways...
FDA Approves Quizartinib for Newly Diagnosed FLT3-ITD–Positive Acute Myeloid Leukemia
On July 20, the U.S. Food and Drug Administration (FDA) approved quizartinib (Vanflyta) with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adults with newly diagnosed acute...
JUPITER-02: Toripalimab Plus Chemotherapy Improved Survival Outcomes for Some Patients With Advanced Nasopharyngeal Carcinoma
In the final overall survival analysis of the phase III JUPITER-02 trial, first-line treatment with toripalimab plus gemcitabine and cisplatin resulted in a statistically significant and clinically meaningful improvement in overall survival and progression-free survival vs chemotherapy alone in...
Olaparib With Abiraterone and Prednisone or Prednisolone for BRCA-Mutated, Metastatic Castration-Resistant Prostate Cancer
On May 31, 2023, the PARP inhibitor olaparib was approved by the U.S. Food and Drug Administration (FDA) with abiraterone and prednisone or prednisolone for the treatment of BRCA-mutated metastatic castration-resistant prostate cancer, as determined by an FDA-approved companion diagnostic test.1...
FDA Approves Iopromide Injection for Contrast-Enhanced Mammography
Iopromide-300 and -370 (Ultravist), an iodine-based contrast agent, has been approved by the U.S. Food and Drug Administration (FDA) for contrast-enhanced mammography—making it the only contrast agent approved for this indication. The product can be used to visualize known or suspected lesions of...
Guideline Update Provides New Testing and Treatment Recommendations for Patients With ER-Positive, HER2-Negative Metastatic Breast Cancer With ESR1 Mutations
Testing for the emergence of ESR1 mutations should be routine at disease recurrence or progression for patients with estrogen receptor (ER)-positive, HER2-negative metastatic breast cancer whose disease is being managed with endocrine therapy, according to an ASCO guideline rapid recommendation...
ASCO Issues Clinical Guidance for Treating Gastrointestinal Cancers Amid Acute Drug Shortages
ASCO has issued new clinical guidance for treating patients with gastrointestinal cancers amid a nationwide shortage of carboplatin and cisplatin. The two chemotherapy agents, in extremely short supply, are essential to treating an array of gastrointestinal cancers—such as esophageal, pancreatic,...
FDA Grants Full Approval to Blinatumomab for MRD-Positive B-Cell Precursor ALL
On June 21, the U.S. Food and Drug Administration (FDA) approved the supplemental biologics license application for blinatumomab (Blincyto) for the treatment of adult and pediatric patients with CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission...
Expert Point of View: Roisin E. O’Cearbhaill, MD
Formal discussant of this late-breaking presentation, Roisin E. O’Cearbhaill, MD, of Memorial Sloan Kettering Cancer Center, New York, commented: “MIRASOL is confirmatory of SORAYA, the trial that led to FDA accelerated approval. The impressive data of MIRASOL show an overall survival advantage in ...
INDIGO Trial: IDH Inhibitor Improves Progression-Free Survival in Grade 2 IDH1/2-Mutated Gliomas
The oral IDH1/2 inhibitor vorasidenib significantly improved progression-free survival in patients with grade 2 gliomas expressing IDH1/2 mutations in the phase III INDIGO trial. These results, which were reported by lead author Ingo K. Mellinghoff, MD, FACP, of Memorial Sloan Kettering Cancer...
FDA Approves Talazoparib With Enzalutamide for HRR Gene–Mutated Metastatic Castration-Resistant Prostate Cancer
On June 20, the U.S. Food and Drug Administration (FDA) approved talazoparib (Talzenna) with enzalutamide for homologous recombination repair (HRR) gene–mutated metastatic castration-resistant prostate cancer. TALAPRO-2 Efficacy was evaluated in TALAPRO-2 (ClinicalTrials.gov identifier...
FDA Launches Pilot Program to Help Reduce Risks Associated With Using Laboratory Developed Tests to Identify Cancer Biomarkers
The U.S. Food and Drug Administration (FDA) announced a new voluntary pilot program to help physicians select safe and effective cancer treatments, with guidance on in vitro companion diagnostic tests to determine which corresponding oncology drugs may provide the most benefit for their patients....
FDA Grants Accelerated Approval to Glofitamab-gxbm for Relapsed or Refractory DLBCL
On June 15, the U.S. Food and Drug Administration (FDA) granted accelerated approval to glofitamab-gxbm (Columvi) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified or large B-cell lymphoma arising from follicular lymphoma,...
Expert Point of View: Devraj Basu, MD, PhD, FACS
Devraj Basu, MD, PhD, FACS, of the Perelman School of Medicine, University of Pennsylvania, an expert in human papillomavirus (HPV)-related oropharyngeal cancer, commented on this study: “This abstract shows lack of awareness of multiple types of HPV-associated cancer and a reduced awareness of...
Rethinking Prior Authorization
Prior authorization of medical procedures, services, and medications has been a standard requirement of health-care providers for decades. Rising health-care costs, specifically the escalating prices of cancer drug therapies, have led to a new focus by payers, providers, and policymakers on prior...
Narjust Florez, MD, and Ticiana Leal, MD, on Metastatic NSCLC: Tumor Treating Fields Therapy After Platinum Resistance
Narjust Florez, MD, of Dana-Farber Cancer Institute, and Ticiana Leal, MD, of Winship Cancer Institute of Emory University, discuss the use of tumor treating fields therapy, in which electric fields disrupt processes critical for cancer cell viability. Already approved by the FDA to treat...
ASCO Issues Clinical Guidance for Treating Gastrointestinal Cancers Amid Acute Drug Shortages
ASCO has issued new clinical guidance for treating patients with gastrointestinal cancers amid a nationwide shortage of carboplatin and cisplatin. The two chemotherapy agents, in extremely short supply, are essential to treating an array of gastrointestinal cancers—such as esophageal cancer,...
Mirvetuximab Soravtansine Improves Survival in Patients With Recurrent Ovarian Cancer
The international phase III MIRASOL randomized clinical trial found that mirvetuximab soravtansine-gynx, an antibody and microtubule inhibitor conjugate, significantly improved progression-free and overall survival for patients with platinum-resistant, advanced high-grade epithelial ovarian,...
Eunice S. Wang, MD, and Gregory Roloff, MD, on B-ALL: Outcomes With Brexucabtagene Autoleucel in Adult Patients
Eunice S. Wang, MD, of Roswell Park Comprehensive Cancer Center, and Gregory Roloff, MD, of the University of Chicago, discuss data that are the first to demonstrate post–FDA approval efficacy and toxicity rates of brexucabtagene autoleucel in adults with relapsed or refractory B-cell acute...
Impact of Changing Opioid Prescription Landscape for Patients With Cancer
Despite the common use of opioids in clinical settings, new and persistent opioid prescriptions have declined among patients both with and without cancer, according to new findings presented by Baum et al at the 2023 ASCO Annual Meeting (Abstract 1592). However, the declines in opioid use among...
FDA Approves Olaparib Plus Abiraterone and Prednisone or Prednisolone for BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer
On May 31, the U.S. Food and Drug Administration (FDA) approved olaparib (Lynparza) in combination with abiraterone and prednisone (or prednisolone) for adult patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer, as determined by an...
ASCO Congratulates 2023 Special Awards Recipients
ASCO and Conquer Cancer, the ASCO Foundation, will recognize researchers, patient advocates, philanthropists, teachers, and global oncology leaders who have reshaped cancer care with the Society’s highest honors at the 2023 ASCO Annual Meeting in Chicago. Hear from select award recipients at the...
FDA Approves Flotufolastat Fluorine-18 Injection, First Radiohybrid PSMA-Targeted PET Imaging Agent for Prostate Cancer
On May 30, the U.S. Food and Drug Administration (FDA) approved the optimized, high-affinity radiohybrid prostate-specific membrane antigen (PSMA)-targeted positron-emission tomography (PET) imaging agent flotufolastat fluorine-18 (Posluma). Flotufolastat F-18 is indicated for PET imaging of...
ASCO Congratulates 2023 Special Awards Recipients
ASCO and Conquer Cancer, the ASCO Foundation, will recognize researchers, patient advocates, philanthropists, teachers, and global oncology leaders who have reshaped cancer care around the world with the Society’s highest honors at the 2023 ASCO Annual Meeting in Chicago. Hear from select award...
NOVA: Final Analysis Confirms No Significant Overall Survival Benefit for Maintenance Niraparib in Recurrent Ovarian Cancer
After resolving missing survival data in the phase III ENGOT-OV16/NOVA trial, no statistically significant difference in overall survival was found for patients with platinum-sensitive recurrent ovarian cancer who received maintenance therapy with the PARP inhibitor niraparib, investigators...
GOG 3026: Durable Responses With Ribociclib Plus Letrozole in Low-Grade Serous Ovarian Cancer
In patients with recurrent low-grade serous ovarian cancer, treatment with ribociclib plus letrozole was not only active, but led to outcomes that are comparable to those achieved with current agents—with a particularly striking 19-month duration of response—according to Brian M. Slomovitz, MD,...
FDA Approves Avapritinib for Indolent Systemic Mastocytosis
On May 22, the U.S. Food and Drug Administration (FDA) approved the tyrosine kinase inhibitor avapritinib (Ayvakit) for the treatment of adults with indolent systemic mastocytosis. Avapritinib is the first and only approved therapy for indolent systemic mastocytosis. Systemic mastocytosis is a rare ...
FDA Grants Accelerated Approval to Epcoritamab-bysp for Relapsed or Refractory B-Cell Lymphoma
On May 19, the U.S. Food and Drug Administration (FDA) granted accelerated approval to the bispecific CD20-directed CD3 T-cell engager epcoritamab-bysp (Epkinly) for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)–not otherwise specified, including DLBCL arising from...
HPV Self-Collection Kits May Increase Cervical Cancer Screenings Among Underscreened, Underserved Patients
Researchers have found that mailing human papillomavirus (HPV) self-collection kits in addition to offering scheduling assistance to underscreened, underserved patients may increase the rate of cervical cancer screenings compared with scheduling assistance alone, according to a new study published...
NOVA: Final Analysis Confirms No Significant Overall Survival Benefit for Maintenance Niraparib in Recurrent Ovarian Cancer
After resolving missing survival data in the phase III ENGOT-OV16/NOVA trial, no statistically significant difference in overall survival was found for patients with platinum-sensitive recurrent ovarian cancer who received maintenance therapy with the PARP inhibitor niraparib, investigators...
GOG 3026: Durable Responses With Ribociclib Plus Letrozole in Low-Grade Serous Ovarian Cancer
In patients with recurrent low-grade serous ovarian cancer, treatment with ribociclib plus letrozole was not only active, but led to outcomes that are comparable to those achieved with current agents—with a particularly striking 19-month duration of response—according to Brian M. Slomovitz, MD,...
ASCO Releases Guideline Updates for Stage IV NSCLC With and Without Driver Alterations
ASCO has updated two living guidelines on the systemic treatment of stage IV non–small cell lung cancer (NSCLC) with and without driver alterations with the inclusion of new evidence-based treatment recommendations.1,2 Among the updates, the guidelines add the recently approved RAS GTPase family...
Novel Hormone Receptor–Driven Therapies Tackling Endocrine Resistance in Breast Cancer
In hormone receptor–positive metastatic breast cancer, tumors eventually become resistant not only to endocrine blockade but to inhibitors of cyclin-dependent kinases 4 and 6 (CDK4/6). This obstacle to successful treatment is being tackled with novel hormone receptor–directed therapies, with the...
Enrollment Criteria for Multiple Myeloma Clinical Trials May Exclude Patients From Racial and Ethnic Minorities
The parameters set to determine which patients can enroll in clinical trials testing new multiple myeloma treatments may disproportionately exclude patients from racial and ethnic minority groups, according to a new study published by Kanapuru et al in the journal Blood. Background Multiple myeloma ...
Emerging Success With Novel Targeted Therapies in Endocrine-Resistant Metastatic Breast Cancer
In hormone receptor–positive breast cancer, the ability to successfully target key mediators of endocrine resistance is changing the outlook of metastatic disease in this subtype, according to Aditya Bardia, MD, MPH, FASCO, Director of Breast Cancer Research and Associate Professor at Harvard...
FDA Approves Polatuzumab Vedotin-piiq Plus R-CHP for Previously Untreated DLBCL–Not Otherwise Specified and High-Grade B-Cell Lymphoma
On April 19, the U.S. Food and Drug Administration (FDA) approved the antibody-drug conjugate polatuzumab vedotin-piiq (Polivy) with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for previously untreated adult patients who have diffuse large B-cell lymphoma (DLBCL)–not...
Awareness of the Link Between HPV and Cervical Cancer Has Declined Between 2014 and 2020
Americans have become less aware that the human papillomavirus (HPV) causes cervical cancer in recent years, according to survey data presented by Adjei Boakye et al at the American Association for Cancer Research (AACR) Annual Meeting 2023 (Abstract 4210 /11). Survey respondents also showed low...
FDA Approves Omidubicel-onlv to Reduce Time to Neutrophil Recovery and Infection in Patients With Hematologic Malignancies
On April 17, the U.S. Food and Drug Administration (FDA) approved omidubicel-onlv (Omisirge) for use in adult and pediatric patients aged 12 years and older with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time ...
