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Showing 401 - 45027th Cancer Leadership Awards Recipients Announced by Friends of Cancer Research
Friends of Cancer Research recently announced its 2023 Cancer Leadership Awards honorees: Commissioner of the U.S. Food and Drug Administration (FDA), Robert Califf, MD, and Congresswoman Debbie Dingell (D-MI). Dr. Califf, recognized for his work in the field of cardiology and the broader medical ...
FDA Approves Momelotinib for Patients With Myelofibrosis and Anemia
On September 15, the U.S. Food and Drug Administration (FDA) approved momelotinib (Ojjaara) for the treatment of intermediate- or high-risk myelofibrosis, including primary myelofibrosis or secondary myelofibrosis (post–polycythemia vera and post–essential thrombocythemia), in adults with anemia....
AACR Issues Annual Cancer Progress Report
The remarkable progress in medical research—primarily supported by federal investments in the National Institutes of Health (NIH) and the National Cancer Institute (NCI)—over the past 3 decades, coupled with advances in cancer prevention and early detection, has led to a 33% reduction in cancer...
FDA Approves New, Updated Indications for Temozolomide
On September 14, the U.S. Food and Drug Administration (FDA) approved updated labeling for temozolomide (Temodar) for the treatment of CNS cancers under Project Renewal, an Oncology Center of Excellence initiative aimed at updating labeling information for older oncology drugs to ensure information ...
FDA Approves New Multiple Myeloma Combination Therapy
On September 11, the U.S. Food and Drug Administration (FDA) approved motixafortide (Aphexda) in combination with filgrastim to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma. Motixafortide is...
Perspectives on Cancer Therapy Development
Long ago, as an ethical alternative to military service, I joined the National Cancer Institute’s Yellow Beret Program, and was assigned to its Division of Cancer Treatment (Dr. Vince DeVita) Cancer Therapy Development Branch (Dr. Steve Carter). This program reviewed and rejected or approved all...
Quizartinib in Newly Diagnosed FLT3-ITD–Positive Acute Myeloid Leukemia
On July 20, 2023, quizartinib was approved for use with standard cytarabine and anthracycline induction and cytarabine consolidation and as maintenance monotherapy following consolidation chemotherapy in adults with newly diagnosed acute myeloid leukemia that is FLT3 internal tandem duplication...
More on Multiple Myeloma From ASCO 2023: Focus on Bispecific Antibodies
Two new bispecific antibodies—teclistamab and talquetamab—have been shown to be active in relapsed or refractory multiple myeloma when used in combination, including in patients with extramedullary disease, without compounding toxicity. Results of two clinical trials with these two agents were...
Study Shows Benefit With Addition of Tumor Treating Fields Therapy in Metastatic Non–Small Cell Lung Cancer
Tumor treating fields (TTF) therapy in combination with immune checkpoint inhibition improved overall survival in the pretreated, primarily immunotherapy-naive setting in metastatic non–small cell lung cancer (NSCLC), according to findings from the phase III LUNAR study. These results were...
Rising After Struggle: Surviving My First ASCO Breakthrough in Japan
After a year of hard work preparing a strong abstract for the prestigious 2023 ASCO Annual Meeting, I finally received an acceptance letter from the scientific committee. I was overjoyed to see the efforts of our multinational team being rewarded. A few moments later, I received the decision...
Vivek Subbiah, MD, Joins SCRI to Advance Early-Phase Clinical Research
Sarah Cannon Research Institute (SCRI) recently announced that Vivek Subbiah, MD, has joined the organization as Chief, Early-Phase Drug Development. In his role, Dr. Subbiah will oversee SCRI’s nine drug development units and lead the expansion of early-phase capabilities and programs across the...
Dostarlimab-gxly With Chemotherapy for Endometrial Cancer
On July 31, 2023, the immune checkpoint inhibitor dostarlimab-gxly was approved by the U.S. Food and Drug Administration (FDA) for use with carboplatin and paclitaxel, followed by single-agent dostarlimab, for patients with primary advanced or recurrent endometrial cancer that is mismatch...
Phase III Trial Reports Chemoimmunotherapy Is Superior to Chemotherapy Alone in Malignant Pleural Mesothelioma
Patients with malignant pleural mesothelioma who were treated with a chemoimmunotherapy regimen containing the immune checkpoint inhibitor pembrolizumab experienced significantly improved overall survival compared with those treated with chemotherapy alone, with acceptable tolerability, according...
23andMe Granted FDA 510(k) Clearance to Report Additional BRCA Variants
23andMe has announced that the company has received a U.S. Food and Drug Administration (FDA) 510(k) clearance to expand its existing BRCA1/BRCA2 (Selected Variants) Genetic Health Risk Report. The clearance allows 23andMe to report an additional 41 variants in the BRCA1 and BRCA2 genes known to be ...
FDA Approves Luspatercept-aamt as First-Line Treatment for Adult Patients With Lower-Risk MDS and Anemia Who May Require Transfusions
On August 28, the U.S. Food and Drug Administration (FDA) approved luspatercept-aamt (Reblozyl) to treat anemia in adult patients with very low– to intermediate-risk myelodysplastic syndromes (MDS) who may require regular red blood cell transfusions and who have not received previous...
Study Shows Potential of Cabozantinib to Treat Patients With Advanced Neuroendocrine Tumors
An interim analysis of the CABINET trial has shown that the phase III pivotal trial has met its primary endpoint, according to a press release from the Alliance for Clinical Trials in Oncology. Cabozantinib demonstrated statistically significant and clinically meaningful improvements in...
Sacituzumab Govitecan-hziy Continues to Show Benefit in Patients With Hormone Receptor–Positive, HER2-Negative Metastatic Breast Cancer
The antibody-drug conjugate sacituzumab govitecan-hziy continued to demonstrate superior benefit for patients with hormone receptor–positive, HER2-negative metastatic breast cancer when compared with standard chemotherapy, according to the final analysis of the phase III TROPiCS-02 study published...
Noninvasive, Multitarget Stool DNA Methylation Assay Under Study in Early Detection of Multiple Gastrointestinal Cancers
A prospective study in China found that a noninvasive, multitarget stool DNA methylation assay was accurate in the early detection and identification of the tissue of origin of gastrointestinal cancers.1 The study, conducted by Li-Yue Sun, MD, of Guangdong Second Provincial General Hospital,...
Expert Point of View: Xin Gao, MD
Xin Gao, MD, Assistant Professor, Harvard Medical School, Genitourinary Cancers Program, Mass General Cancer Center, commented on the results from TROPHY-U-01 cohort 2. “These data add to the overall data on the efficacy of sacituzumab govitecan in patients with metastatic urothelial cancer. This...
Expert Point of View: Monica Chatwal, MD
Medical oncologist Monica Chatwal, MD, of Moffitt Cancer Center, Tampa, Florida, commented on the take-home points from the ARASENS trial. “The ARASENS trial continues to show a survival benefit for a triplet therapy approach in metastatic hormone-sensitive prostate cancer with androgen-deprivation ...
Expert Point of View: Oliver Sartor, MD
The results of recent trials of PARP (poly [ADP-ribose] polymerase) inhibitor plus second-generation androgen receptor inhibitor combinations have had varying results in metastatic castration-resistant prostate cancer. Some trials suggest the benefit is confined to those with BRCA mutations and/or...
Genitourinary Oncology 2023 Almanac
It is an exciting time in the development of new treatments for urologic cancers. There have been a number of major changes both in advanced disease and in the perioperative setting over the past year. Urothelial and Bladder Cancers In urothelial cancer, at last, we have randomized data supporting...
FDA Approves Melphalan Hepatic Delivery System for Adult Patients With Unresectable Hepatic-Dominant Metastatic Uveal Melanoma
On August 14, the U.S. Food and Drug Administration (FDA) approved the HEPZATO KIT, a melphalan hepatic delivery system, as a liver-directed treatment for adult patients with metastatic uveal melanoma and unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic...
Accelerated Approval for Elranatamab-bcmm in Patients With Relapsed or Refractory Multiple Myeloma
On August 14, the U.S. Food and Drug Administration (FDA) granted accelerated approval to elranatamab-bcmm (Elrexfio), a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, for adult patients with relapsed or refractory multiple myeloma who have received at least four prior...
Recent FDA Approvals in Hematologic Oncology
Over the past year, the U.S. Food and Drug Administration (FDA) granted approval to several novel drugs and new indications for older therapeutic agents used in hematologic oncology. Glofitamab for DLBCL On June 15, 2023, the FDA granted accelerated approval to glofitamab-gxbm (Columvi) for...
Is 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,...
