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Showing 1401 - 1450FDA Grants Accelerated Approval to Zanubrutinib for Pretreated Mantle Cell Lymphoma
On November 14, the U.S. Food and Drug Administration (FDA) granted accelerated approval to zanubrutinib (Brukinsa) for adult patients with mantle cell lymphoma who have received at least one prior therapy. “Mantle cell lymphoma usually responds well to initial treatment, but eventually returns or ...
Fedratinib: Back From Development Limbo for the Treatment of Myeloproliferative Neoplasms
In September 2019, Dr. Claire Harrison and colleagues, myself among them, presented two new analyses regarding the use of the JAK2 and FLT3 inhibitor fedratinib in myelofibrosis at the Society of Hematologic Oncology (SOHO) Annual Meeting, with resulting publication in Clinical Lymphoma, Myeloma...
Venetoclax for Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
On May 15, 2019, venetoclax was approved for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).1,2 Supporting Efficacy Data Approval was based on findings from the open-label phase III CLL14 trial (ClinicalTrials.gov...
FDA Awards Research Grants for the Study of Rare Cancers
The U.S. Food and Drug Administration (FDA) recently awarded 12 new clinical trial research grants totaling more than $15 million over the next 4 years, many of them focusing on cancer. Also, the FDA awarded two new research grants for natural history studies in rare diseases, totaling more than...
FDA Approves Luspatercept-aamt for Anemia in Patients With Beta Thalassemia
On November 8, the U.S. Food and Drug Administration (FDA) approved luspatercept-aamt (Reblozyl) for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell transfusions. Beta thalassemia is a blood disorder that reduces the production of hemoglobin. In...
Addition of Durvalumab to Etoposide Plus Platinum Chemotherapy for Extensive-Stage SCLC
This week, we’ll review an interim analysis of the CASPIAN trial, which evaluated the addition of durvalumab to etoposide plus platinum chemotherapy for extensive-stage small cell lung cancer. Then, we’ll talk about two recently issued guidelines on screening for colorectal cancer. Lastly, we’ll...
Daratumumab Combination Therapy for Patients With Multiple Myeloma Who Are Eligible for Transplantation
On September 26, 2019, daratumu-mab (Darzalex) was approved in combination with bortezomib, thalidomide, and dexamethasone for the treatment of multiple myeloma in newly diagnosed adult patients eligible for autologous stem cell transplantation (ASCT).1,2 Supporting Efficacy Data Approval was based ...
Race Reporting and Representation in Clinical Trials Leading to Cancer Drug Approvals
In a study reported in JAMA Oncology,1Jonathan M. Loree, MD, of BC Cancer, Vancouver, British Columbia, Canada, and colleagues found that race and race subgroup analyses were frequently not included in reported trials supporting U.S. Food and Drug Administration (FDA) oncology drug approvals...
Immunotherapy Combinations Redefine Outcomes for Patients With Advanced Renal Cell Carcinoma
The treatment landscape for patients with advanced renal cell carcinoma has changed drastically over the past several years with the introduction of many new therapeutic options for patients. The revolution began with the U.S. Food and Drug Administration (FDA) approval of nivolumab and ipilimumab...
Personalized Treatment Approaches on the Horizon for Myelodysplastic Syndromes
Despite the spate of recent drug approvals in blood cancer, it’s been more than 13 years since the U.S. Food and Drug Administration (FDA) has approved a treatment for myelodysplastic syndromes (MDS), a bone marrow disorder characterized by ineffective hematopoiesis. Nevertheless, data from a...
FDA Office of Hematology Oncology Products Reorganizes, Renamed Office of Oncologic Diseases
As part of modernization plans approved in September 2019, the U.S. Food and Drug Administration (FDA) office responsible for reviewing applications for new and existing cancer therapies has reorganized and been renamed. The Center for Drug Evaluation and Research (CDER) Office of Hematology and...
FDA Approves Pegfilgrastim Biosimilar
On November 5, the U.S. Food and Drug Administration (FDA) approved a biosimilar to pegfilgrastim, pegfilgrastim-bmez (Ziextenzo). Pegfilgrastim-bmez is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving...
Stephen Hahn, MD, to Be Nominated FDA Commissioner
In a press release issued by the White House today, President Donald J. Trump announced his intention to nominate Stephen Hahn, MD, FASTRO, to be the Commissioner of Food and Drugs at the Department of Health and Human Services. Dr. Hahn has been Chief Medical Executive at The University of Texas...
FDA Issues Drug Safety Communication on Lung Inflammation Linked 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: Treatments for HER2-Positive Breast Cancer, AML; Breakthrough Device for Prostate Cancer; Statement on Safety Information for Breast Implants
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to trastuzumab deruxtecan for the treatment of HER2-positive metastatic breast cancer; granted Fast Track designation for bemcentinib for elderly patients with relapsed acute myeloid leukemia (AML); granted Breakthrough...
FDA Approves Niraparib for Patients With Homologous Recombination Deficiency–Positive Advanced Ovarian Cancer
On October 23, the U.S. Food and Drug Administration (FDA) approved niraparib (Zejula) for patients with advanced ovarian, fallopian tube, or primary peritoneal cancer treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination...
Fedratinib for Myelofibrosis
On August 16, 2019, fedratinib was approved for the treatment of adults with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis.1,2 Supporting Efficacy Data The approval was based on findings from the phase III double-blind...
City of Hope Enrolling Patients With Brain Tumors in First-of-Its-Kind Clinical Trial
City of Hope has opened a first-in-human clinical trial for patients with recurrent glioblastoma. The trial is the first to combine City of Hope’s chimeric antigen receptor (CAR) T cells that target the IL13Rα2 antigen common on brain tumor cells in combination with nivolumab and ipilimumab. To...
Pembrolizumab/Lenvatinib in Advanced Endometrial Carcinoma Without Microsatellite Instability–High or Mismatch Repair–Deficient Disease
On September 17, 2019, the combination of pembrolizumab plus lenvatinib was granted accelerated approval for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability–high (MSI-H) or mismatch repair–deficient (dMMR) and who have disease progression...
FDA Approves Label Expansion for Single-Dose Regimen of Intravenous Aprepitant for Patients Receiving Moderately Emetogenic Chemotherapy
On October 22, the U.S. Food and Drug Administration (FDA) approved a supplemental new drug application (sNDA) for aprepitant (Cinvanti) injectable emulsion for intravenous (IV) use. The sNDA requested FDA approval to expand the recommended dosage to include the 130-mg single-dose regimen for...
Update to FDA Prescribing Information for Romiplostim for Adults With Immune Thrombocytopenia
On October 18, the U.S. Food and Drug Administration (FDA) approved a supplemental biologics license application (sBLA) for romiplostim (Nplate) to include new data in its U.S. prescribing information showing sustained platelet responses in adults with immune thrombocytopenia. The updated...
The Future of the Radiation Abscopal Response
“Two roads diverged in a wood, and I—I took the one less traveled by,And that has made all the difference.” –Robert Frost One of the first patients I encountered after residency was a 26-year-old woman with a single brain metastasis from melanoma. For anonymity, let’s call her Anna. Anna had just...
FDA Pipeline: Designations for Acute Graft-vs-Host Disease, Peripheral T-Cell Lymphoma
Recently, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to a therapy for steroid-refractory acute graft-vs-host disease and granted Orphan Drug designation to a therapy for peripheral T-cell lymphoma. Fast Track Designation for T-Guard in Steroid-Refractory Acute...
Pooled Analysis of Outcomes in Older Women With Metastatic Breast Cancer Receiving CDK4/6 Inhibitor Plus Aromatase Inhibitor Therapy
In a U.S. Food and Drug Administration (FDA) pooled analysis reported in the Journal of Clinical Oncology, Howie et al found that progression-free survival and benefit were similar for older vs younger postmenopausal women treated with combined cyclin-dependent kinase 4/6 (CDK4/6) plus aromatase...
Atezolizumab for PD-L1–Positive Locally Advanced or Metastatic Triple-Negative Breast Cancer
EARLIER THIS YEAR, atezolizumab was granted accelerated approval in combination with nab-paclitaxel in the treatment of patients with unresectable locally advanced or metastatic triple-negative breast cancer whose tumors express programmed cell death ligand 1 (PD-L1–stained tumor-infiltrating...
Biosimilar 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...
