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Showing 1451 - 1500Biosimilar to Trastuzumab in HER2-Overexpressing Breast, Metastatic Breast, and Metastatic Gastric Cancers
Early in 2019, trastuzumab-dttb was approved as a biosimilar to standard trastuzumab for treatment of HER2-expressing breast cancer in the adjuvant setting, metastatic breast cancer, and metastatic gastric cancer or gastroesophageal junction adenocarcinoma in patients who have not received prior...
Gene Therapy: A March Forward!
GUEST EDITORS Dr. Abutalib is Associate Director, Hematology and Cellular Therapy Program and Director, Clinical Apheresis Program Cancer Treatment at Centers of America, Zion, Illinois; Associate Professor, Rosalind Franklin University of Medicine and Science; and Founder and Co-Editor of...
Entrectinib for NTRK-Positive Solid Tumors and ROS1-Positive Lung Cancer
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On August 15, 2019, the oral TRK, ROS1, and ALK kinase...
FDA Pipeline: Advances in Prostate Cancer, Urothelial Cancer, Myelofibrosis, and More
In the past few weeks, the U.S. Food and Drug Administration (FDA) has issued regulatory decisions in prostate cancer, urothelial cancer, myelofibrosis, breast cancer, pediatric brain cancer, leukemia, and skin cancer. Breakthrough Therapy Designation for Niraparib in Metastatic...
Selpercatinib: Precision Medicine for RET Fusion–Positive NSCLC
Selpercatinib (LOXO-292), a RET kinase inhibitor, demonstrated antitumor activity in the lungs and brain and durable responses with acceptable tolerability in patients with RET fusion–positive non–small cell lung cancer (NSCLC), according to an updated analysis of the LIBRETTO-001 registration...
ESMO 2019: LIBRETTO-001 Trial of Selpercatinib in RET Fusion–Positive Thyroid Cancer
Patients with advanced RET fusion–positive thyroid cancer and RET-mutant medullary thyroid cancer had high rates of response following treatment with selpercatinib, according to findings from the phase I/II LIBRETTO-001 trial presented by Wirth et al at the European Society for Medical Oncology...
FDA Approves Daratumumab Combination for Transplant-Eligible Patients With Multiple Myeloma
On September 26, 2019, the U.S. Food and Drug Administration approved daratumumab (Darzalex) in combination with bortezomib, thalidomide, and dexamethasone for newly diagnosed adult patients with multiple myeloma who are eligible for autologous stem cell transplant (ASCT). Efficacy was investigated ...
FDA Announces Voluntary Recall of Certain Ranitidine Capsules
This week, the U.S. Food and Drug Administration (FDA) alerted health-care professionals and patients of a voluntary recall of 14 lots of prescription ranitidine capsules distributed by Sandoz Inc, used to decrease the amount of acid created by the stomach. This recall is due to a nitrosamine...
Ned Sharpless, MD, Testifies Before House Subcommittee on FDA Investigation of Vaping Illnesses and Regulation of E-Cigarettes
Earlier this week, Acting Commissioner of the U.S. Food and Drug Administration (FDA) Ned Sharpless, MD, testified before the U.S. House Energy and Commerce Subcommittee on the FDA’s planned regulation of electronic nicotine delivery systems and investigation of vaping illnesses. His remarks are...
CMS Expands Coverage of CAR T-Cell Therapy for Medicare Beneficiaries
The Centers for Medicare & Medicaid Services (CMS) released a new national coverage determination (NCD) announcing that Medicare will now cover U.S. Food and Drug Administration (FDA)-approved chimeric antigen receptor T-cell (CAR T-cell) therapy for certain patients with cancer. As outlined in ...
Avelumab Plus Axitinib in Advanced Renal Cell Carcinoma
Earlier this year, avelumab was approved for use in combination with axitinib for the first-line treatment of patients with advanced renal cell carcinoma.1,2 Supporting Efficacy Data Approval was based on findings in the open-label phase III -JAVELIN Renal 101 trial (ClinicalTrials.gov identifier...
Ramucirumab in Hepatocellular Carcinoma
Earlier this year, ramucirumab was approved as a single agent for hepatocellular carcinoma in patients who have an alpha-fetoprotein (AFP) level ≥ 400 ng/mL and have been previously treated with sorafenib.1,2 Supporting Efficacy Data Approval was based on findings in the double-blind phase III...
FDA Approves Cologuard for Persons Aged 45 and Older at Average Risk for Colorectal Cancer
Today, the U.S. Food and Drug Administration (FDA) approved the noninvasive colorectal cancer screening test Cologuard for eligible average-risk individuals aged 45 years and older, expanding on its previous indication for those aged 50 years and older. Cologuard is a stool DNA-based colorectal...
News From the ASTRO Annual Meeting
This week, we’ll be going over news from the 2019 American Society for Radiation Oncology (ASTRO) Annual Meeting, including an analysis of the effect of long-term hormonal therapy on men with low prostate-specific antigen levels treated with early salvage radiotherapy after radical prostatectomy...
Patient-Centered Initiatives at the FDA
OCE Insights is a periodic column 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 first installment, Vishal Bhatnagar, MD, Acting Associate Director of Patient Outcomes; Bellinda King-Kallimanis, PhD, Senior...
Adjuvant Treatment With Ado-trastuzumab Emtansine in HER2-Positive Early Breast Cancer
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Earlier this year, ado-trastuzumab emtansine (T-DM1) was...
AACR Cancer Progress Report 2019 Released
Today, the American Association for Cancer Research (AACR) released the AACR Cancer Progress Report 2019, which highlights how research largely supported by federal investments in the National Institutes of Health (NIH) is spurring improvements in public health and innovations across the spectrum...
FDA Approves Apalutamide for Metastatic Castration-Sensitive Prostate Cancer
On September 17, the U.S. Food and Drug Administration (FDA) approved apalutamide (Erleada) for patients with metastatic castration-sensitive prostate cancer. Apalutamide was initially approved by the FDA in 2018 for patients with nonmetastatic castration-resistant prostate cancer. TITAN Trial...
FDA Grants Approval to Lenvatinib/Pembrolizumab in Advanced Endometrial Cancer, Announces Project Orbis
The U.S. Food and Drug Administration (FDA) has announced Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE). Project Orbis provides a framework for concurrent submission and review of oncology drugs among its international partners. Under this project, the FDA, the...
Targeting an Important Tumor Vulnerability With Maintenance Olaparib in Germline BRCA-Mutated Pancreatic Cancer
In the POLO trial, which is discussed in this issue of The ASCO Post, Golan and colleagues evaluated the potential benefit of maintenance olaparib after disease stability or response to a minimum of 4 months of platinum-based chemotherapy in patients with metastatic pancreatic cancer and a...
FDA Issues Drug Safety Communication on Lung Inflammation Due to Treatment With CDK4/6 Inhibitors
On September 13, the U.S. Food and Drug Administration (FDA) issued a drug safety communication warning that palbociclib, ribociclib, and abemaciclib—used to treat some patients with advanced breast cancer—may cause rare but severe inflammation of the lungs. The agency approved new warnings about...
FDA Pipeline: Breakthrough Therapy Designation in Lung Cancer, Orphan Drug Designations in Myeloma and Soft-Tissue Sarcoma
Recently, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to tepotinib for metastatic non–small cell lung cancer harboring MET exon 14 skipping alterations, and Orphan Drug designations to novel chimeric antigen receptor T-cell therapies in both multiple myeloma ...
FDA Proposes New Required Health Warnings With Images for Cigarette Packages and Advertisements
On August 15, the U.S. Food and Drug Administration (FDA) issued a proposed rule to require new health warnings on cigarette packages and in advertisements to promote greater public understanding of the negative health consequences of smoking. The proposed warnings, which feature photo-realistic...
Alpelisib for PIK3CA-Mutated Advanced Breast Cancer
On May 24, 2019, alpelisib was approved for use in combination with fulvestrant for postmenopausal women, and men, with hormone receptor–positive, HER2-negative, PIK3CA-mutated advanced or metastatic breast cancer, as detected by a U.S. Food and Drug Administration (FDA)-approved test following...
Pembrolizumab in Advanced Esophageal Squamous Cell Cancer With PD-L1 Expression of CPS ≥ 10
On July 30, 2019, pembrolizumab was approved for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express programmed cell death ligand 1 (PD-L1; Combined Positive Score [CPS] ≥ 10), as determined by a U.S. Food and Drug...
Pembrolizumab in First-Line Treatment of Head/Neck Squamous Cell Carcinoma
On June 10, 2019, pembrolizumab was approved for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma.1,2 Pembrolizumab was approved for use in combination with platinum and fluorouracil (5-FU) for all patients and as a single agent...
Daratumumab-Based Therapy for Patients With Newly Diagnosed Multiple Myeloma Who Are Ineligible for Transplantation
On June 27, 2019, daratumumab was approved for use in combination with lenalidomide and dexamethasone for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation.1,2 Supporting Efficacy Data Approval was based on findings in the open-label phase...
Insightful Advice From a College Advisor Leads to an Unexpected Career in Oncology
For this installment of the Living a Full Life series, guest editor Jame Abraham, MD, FACP, spoke with Tatiana M. Prowell, MD, who currently serves as Associate Professor of Oncology in the Breast Cancer Program at the Johns Hopkins Kimmel Comprehensive Cancer Center and as a Medical Officer and...
Lenalidomide for Previously Treated Follicular and Marginal Zone Lymphomas
On May 28, 2019, lenalidomide was approved for use in combination with a rituximab product for previously treated follicular lymphoma and previously treated marginal zone lymphoma.1,2 Supporting Efficacy Data Approval was based on the findings of two clinical trials: AUGMENT (ClinicalTrials.gov...
FDA OCE and Syapse Announce Research Collaboration Focused on Regulatory Use of Real-World Evidence
Syapse and the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) have signed a multiyear research collaboration agreement focused on the use of real-world evidence to support regulatory decision-making. Syapse and the OCE will work with stakeholders across the FDA to...
Update on FDA-Approved CAR T-Cell Gene Therapy for B-Cell Lymphomas
On October 18, 2017, the U.S. Food and Drug Administration (FDA) granted approval to axicabtagene ciloleucel for the treatment of adult patients with relapsed or refractory large B-cell lymphoma. Specifically, this treatment can be used after two or more lines of systemic therapy for diffuse...
FDA Approves Entrectinib for NTRK-Fusion Cancers, ROS1-Positive NSCLC
On August 15, the U.S. Food and Drug Administration (FDA) granted accelerated approval to entrectinib (Rozlytrek) for adult and adolescent patients whose cancers have an NTRK (neurotrophic tyrosine receptor kinase) genetic fusion and for whom there are no effective treatments. Entrectinib was also...
FDA Approves Fedratinib for Treatment of Myelofibrosis
On August 16, the U.S. Food and Drug Administration (FDA) approved the Janus kinase 2 (JAK2) inhibitor fedratinib (Inrebic) for the treatment of adults with intermediate-2 or high-risk primary or secondary (postpolycythemia vera or postessential thrombocythemia) myelofibrosis. “Prior to [this...
FDA Pipeline: Fast Track Designation in Myelodysplastic Syndrome and AML, Plus Multiple Breakthrough Designations
Recently, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to magrolimab in myelodysplastic syndrome and acute myeloid leukemia (AML). The agency also granted Breakthrough Therapy designations in lung cancer and desmoid tumors, as well as Breakthrough Device designations...
New Report Finds Cancer Drugs Account for Over a Quarter of All New Drug Approvals in the United States
Cancer drugs currently account for 27% of all new drug approvals in the United States since 2010—an increase from the 4% share they occupied in the 1980s, a newly completed analysis summarized in the most recent issue of the Tufts CSDD Impact Report. From 1980 through 2018, the U.S. Food and Drug...
2019 Quality Care: Clinical Trial Enrollment May Be Associated With Reduced Mortality in Patients With Metastatic Lung Cancer
Researchers from the University of Washington and Fred Hutchinson Cancer Research Center in Seattle investigated the relationship between participation in a clinical trial and overall survival in patients with advanced non–small cell lung cancer (NSCLC). Cristina Merkhofer, MD, MHS, will present...
FDA Recommendation on Duodenoscopes With Disposable Components
The U.S. Food and Drug Administration (FDA) has recommended that duodenoscope manufacturers and health-care facilities transition to different types of duodenoscopes that may pose less risk to patient safety. Specifically, because of challenges with cleaning these devices for reuse and persistent...
Pooled Survival Analysis of Patients With NSCLC Treated With Nivolumab
This week, we review a pooled analysis of long-term survival rates in patients with previously treated non–small cell lung cancer treated with nivolumab. We then turn to the recently reported USPSTF recommendation on risk assessment, genetic counseling, and genetic testing for BRCA1 or BRCA2...
FDA Issues Draft Guidance Encouraging Inclusion of Male Patients in Breast Cancer Clinical Trials
A draft guidance issued by the U.S. Food Drug Administration (FDA) on August 26 includes draft recommendations for the inclusion of male patients in breast cancer clinical trials. Historically, males either have not been included in clinical trials for drugs to treat breast cancer, or inclusion of...
FDA Clears Next-Generation Scalp-Cooling Device
ON JUNE 27, 2019, the U.S. Food and Drug Administration (FDA) granted clearance of the DigniCap Delta scalp-cooling system to Dignitana, for use by health-care providers in the United States. The device is a fourth generation of the DigniCap scalp-cooling system. It is indicated to reduce the...
Novel Treatments Under Study in Renal Cell Carcinoma and Prostate Cancer
There were numerous notable presentations at the 2019 Genitourinary Cancers Symposium, many of which were covered in The ASCO Post over the past few months. To add to our continued coverage of this meeting, here are some highlights from studies focusing on novel therapeutics in renal cell carcinoma ...
Some Practices May Not Be Subject to USP and Standards
ASCO recently received clarification from the United States Pharmacopeia (USP) around the newly revised USP General Chapter <797> Pharmaceutical Compounding Standards–Sterile Preparations and USP General Chapter <800> Hazardous Drugs–Handling in Health-Care Settings, which become...
Register for ASCO’s Research Community Forum 2019 Annual Meeting
Registration is open for the ASCO Research Community Forum (RCF) 2019 Annual Meeting. The ASCO RCF Annual Meeting brings together physician-investigators and research staff from across the country for 2 days of learning and collaboration. The meeting offers colleagues from a variety of research...
Darolutamide for Nonmetastatic Castration-Resistant Prostate Cancer
On July 30, 2019, darolutamide was approved for the treatment of patients with nonmetastatic castration-resistant prostate cancer.1,2 Approval was based on findings in the double-blind phase III ARAMIS trial (ClinicalTrials.gov identifier NCT02200614), in which 1,509 patients were randomly assigned ...
Novel Treatments Under Study in Renal Cell Carcinoma and Prostate Cancer
There were numerous notable presentations at the 2019 Genitourinary Cancers Symposium, many of which were covered in The ASCO Post over the past few months. To add to our continued coverage of this meeting, here are some highlights from studies focusing on novel therapeutics in renal cell carcinoma ...
Selinexor in Relapsed or Refractory Multiple Myeloma
In the Clinic provides overviews of novel hematology and oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On July 3, 2019, the oral nuclear export...
FDA Clears Next-Generation Scalp-Cooling Device
ON JUNE 27, 2019, the U.S. Food and Drug Administration (FDA) granted clearance of the DigniCap Delta scalp-cooling system to Dignitana, for use by health-care providers in the United States. The device is a fourth generation of the DigniCap scalp-cooling system. It is indicated to reduce the...
FDA Approves Pexidartinib for Tenosynovial Giant Cell Tumor
ON AUGUST 2, the U.S. Food and Drug Administration (FDA) granted approval to pexidartinib (Turalio) capsules for the treatment of adult patients with symptomatic tenosynovial giant cell tumor associated with severe morbidity or functional limitations and not responsive to improvement with surgery. ...
FDA Approves Darolutamide for Nonmetastatic Castration-Resistant Prostate Cancer
ON JULY 30, the U.S. Food and Drug Administration (FDA) approved darolutamide (Nubeqa) for the treatment of nonmetastatic castration-resistant prostate cancer. Approval was based on the ARAMIS study, a multicenter, double-blind, placebo-controlled clinical trial of 1,509 patients with nonmetastatic ...
CMS Finalizes Decision to Cover CAR T-Cell Therapy for Medicare Beneficiaries
ON AUGUST 7, the Centers for Medicare & Medicaid Services (CMS) finalized the decision to cover U.S. Food and Drug Administration (FDA)-approved chimeric antigen receptor (CAR) T-cell therapy among recipients of Medicare benefits. FDA-approved CAR T-cell therapies are approved to treat patients ...
