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Showing 401 - 450Optimizing Treatment Selection for Newly Diagnosed and Secondary AML: Focus on Cytogenetic and Molecular Data
Greater understanding of biological disease factors in acute myeloid leukemia (AML) has led to more effective and personalized treatment options. At the 2023 National Comprehensive Cancer Network (NCCN) Annual Congress: Hematologic Malignancies,1 Rebecca Olin, MD, MSCE, of UCSF Helen Diller Family...
FDA Approves Enzalutamide for Nonmetastatic Castration-Sensitive Prostate Cancer With Biochemical Recurrence
On November 16, the U.S. Food and Drug Administration (FDA) approved the androgen receptor inhibitor enzalutamide (Xtandi) for patients with nonmetastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis. EMBARK Trial Efficacy was evaluated in EMBARK...
AACR Annual Cancer Progress Report Highlights Scientific Advances Against Cancer, Challenges and Opportunities Ahead
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 prevention and early detection, has led to a 33% reduction in cancer...
FDA Approves Capivasertib With Fulvestrant for Breast Cancer
On November 16, 2023, the U.S. Food and Drug Administration (FDA) approved capivasertib (Truqap) with fulvestrant for adult patients with hormone receptor–positive, HER2-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN alterations, as detected by an...
FDA Approves Next-Generation Tyrosine Kinase Inhibitor Repotrectinib for ROS1-Positive NSCLC
On November 15, 2023, the U.S. Food and Drug Administration (FDA) approved the next-generation tyrosine kinase inhibitor repotrectinib (Augtyro) for the treatment of locally advanced or metastatic ROS1-positive non–small cell lung cancer (NSCLC). According to the American Lung Association, the ROS1 ...
FDA Approves First Treatment for Patients With Rare Congenital Blood Disorder
On November 9, the U.S. Food and Drug Administration (FDA) approved ADAMTS13, recombinant-krhn (Adzynma), the first genetically engineered protein product indicated for prophylactic or on-demand enzyme replacement therapy in adult and pediatric patients with congenital thrombotic thrombocytopenic...
FDA Amends Pembrolizumab’s Gastric Cancer Indication
On November 7, the U.S. Food and Drug Administration (FDA) revised the existing indication of pembrolizumab (Keytruda) in combination with trastuzumab, fluoropyrimidine, and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic...
FDA Approves Fruquintinib for Refractory Metastatic Colorectal Cancer
On November 8, the U.S. Food and Drug Administration (FDA) approved fruquintinib (Fruzaqla) for adult patients with metastatic colorectal cancer who received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy; an anti-VEGF therapy; and—if their disease is RAS wild-type and it...
2023 National Youth Tobacco Survey Shows Drop in E-Cigarette Use Among High School Students
On November 2, the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) released data from the 2023 National Youth Tobacco Survey (NYTS) on tobacco product use among U.S. youth. The findings—which were collected between March and June 2023 and were...
FDA Approves Pembrolizumab Plus Chemotherapy for Biliary Tract Cancer
On October 31, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) to be used with gemcitabine and cisplatin for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer. KEYNOTE-966 Efficacy was evaluated in KEYNOTE-966...
FDA Approves Toripalimab-tpzi for Nasopharyngeal Carcinoma
On October 27, the U.S. Food and Drug Administration (FDA) approved toripalimab-tpzi (Loqtorz) with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced nasopharyngeal carcinoma. The FDA also approved toripalimab-tpzi as a single agent for...
FDA Approves Ivosidenib for Myelodysplastic Syndromes
On October 24, the U.S. Food and Drug Administration (FDA) approved ivosidenib (Tibsovo) for adult patients with relapsed or refractory myelodysplastic syndromes (MDS) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation, as detected by an FDA-approved test. The FDA also approved the...
ASCO Response to Drug Shortages Request for Information
The Association for Clinical Oncology (ASCO) responded to a bicameral Request for Information (RFI) on the underlying factors driving drug shortages. The Association’s comments highlighted the impact of the shortages on patient care and pointed to economic failures and supply chain vulnerabilities...
FDA Expands Pediatric Indication for Entrectinib and Approves New Pellet Formulation
On October 20, the U.S. Food and Drug Administration (FDA) granted accelerated approval to the small-molecule tyrosine kinase inhibitor entrectinib (Rozlytrek) for pediatric patients aged 1 month and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion...
Is Idecabtagene Vicleucel Effective in Patients With Multiple Myeloma, Regardless of Race?
The chimeric antigen receptor (CAR) T-cell therapy idecabtagene vicleucel may offer an overall survival benefit in patients with multiple myeloma, regardless of their race or ethnicity, according to a novel study published by Peres et al in Blood Advances. Background Multiple myeloma—a cancer of...
Almost Half of Oncology Drugs Approved Since 1998 Have Been Precision Therapies, New Study Finds
Among the 198 new oncology drugs approved by the U.S. Food and Drug Administration (FDA) between 1998 and 2022, approximately 43% of them were precision therapies, according to a recent study published by Suehnholz et al in Cancer Discovery. Background Precision oncology therapies often require...
FDA Approves Neoadjuvant/Adjuvant Pembrolizumab for Resectable NSCLC
On October 16, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) with platinum-containing chemotherapy as neoadjuvant treatment, and with continuation of single-agent pembrolizumab as postsurgical adjuvant treatment, for resectable (tumors ≥ 4 cm or node-positive)...
Recent FDA Approvals in Breast Cancer
Over the past year, the U.S. Food and Drug Administration (FDA) granted approval to several novel drugs and expanded indications for older therapeutic agents used in breast cancer. Abemaciclib Plus Endocrine Therapy On March 3, 2023, the FDA expanded the indication for abemaciclib with endocrine...
FDA Approves Adjuvant Nivolumab for Stage IIB/IIC Melanoma
On October 13, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo) for the adjuvant treatment of completely resected stage IIB or IIC melanoma in patients aged 12 years and older. CheckMate 76K Efficacy was evaluated in CheckMate 76K (ClinicalTrials.gov identifier NCT04099251),...
FDA Approves Encorafenib With Binimetinib for Metastatic BRAF V600E–Mutated NSCLC
On October 11, the U.S. Food and Drug Administration (FDA) approved the BRAF inhibitor encorafenib (Braftovi) with the MEK inhibitor binimetinib (Mektovi) for adult patients with metastatic non–small cell lung cancer (NSCLC) and a BRAF V600E mutation, as detected by an FDA-approved test. The FDA...
FDA Grants Marketing Authorization to Edison Histotripsy System for Treatment of Liver Tumors
On October 9, HistoSonics, the manufacturer of the Edison System and novel histotripsy therapy platforms, announced the marketing authorization of its platform via the U.S. Food and Drug Administration's (FDA) De Novo Classification Request process, a rigorous premarket review pathway for medical...
Accelerated Approval Granted for Use of Elranatamab-bcmm in Relapsed or Refractory Multiple Myeloma
On August 14, 2023, the bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager elranatamab-bcmm was granted accelerated approval by the U.S. Food and Drug Administration (FDA) for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of...
Tracking the Progress Being Made in the Treatment of Breast Cancer and the Challenges Ahead
Jame Abraham, MD, FACP, has been in the field of oncology for more than 2 decades, he and says this is both one of the most exhilarating and challenging times in cancer care. “What excites me the most are the innovations in treatment that are literally transforming the lives of our patients and...
FDA Grants First Marketing Authorization for a DNA Test to Assess Predisposition for Dozens of Cancer Types
On September 29, the U.S. Food and Drug Administration (FDA) granted de novo marketing authorization for the Invitae Common Hereditary Cancers Panel, an in vitro diagnostic test that may help detect hundreds of genetic variants associated with an elevated risk of developing certain cancers. The...
FDA Approves Bosutinib for Pediatric Patients With Chronic Myelogenous Leukemia
On September 26, the U.S. Food and Drug Administration (FDA) approved bosutinib (Bosulif) for pediatric patients aged 1 year and older with chronic-phase, Philadelphia chromosome–positive chronic myelogenous leukemia (CML) that is newly diagnosed or resistant or intolerant to prior therapy. The FDA ...
27th 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...
