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Showing 1501 - 1550FDA Approves Pembrolizumab for Some Patients With PD-L1–Positive Esophageal Cancer
On July 30, the U.S. Food and Drug Administration (FDA) approved the programmed cell death protein 1 inhibitor pembrolizumab (Keytruda) as monotherapy for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express programmed ...
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...
FDA Pipeline: Label Update for Durvalumab in NSCLC; Applications Accepted in Epithelioid Sarcoma, AML
Recently, the U.S. Food and Drug Administration (FDA) approved the inclusion of overall survival from the PACIFIC trial in the U.S. prescribing information for durvalumab and accepted applications for a new drug in the treatment of epithelioid sarcoma and two orphan drugs in the treatment of acute...
Director of the FDA’s Oncology Center of Excellence Discusses Expanded Access, Accelerated Drug Approvals in Latest ASCO in Action Podcast
THE DIRECTOR OF the U.S. Food and Drug Administration’s (FDA) Oncology Center of Excellence (OCE), Richard Pazdur, MD, joins ASCO Chief Executive Officer Clifford A. Hudis, MD, FACP, FASCO, in the latest ASCO in Action Podcast to discuss the FDA’s new program to make it easier for physicians to...
Friends of Cancer Research Launches Next Phase in Real-World Evidence Initiative
FRIENDS OF CANCER RESEARCH (Friends) is launching the next phase of its Real-World Evidence pilot project after a broad stakeholder meeting in February 2019. At the meeting, the U.S. Food and Drug Administration (FDA) and various data partners expressed interest in continuing to address several...
Update on Newer Treatments in Non-Hodgkin Lymphomas
As part of The ASCO Post’s coverage of the 2019 ASCO Annual Meeting, featured here are summaries of five abstracts of different clinical trials evaluating newer treatments for follicular and marginal zone lymphomas as well as diffuse large B-cell lymphoma. Follicular and Marginal Zone Lymphomas...
FDA Approves Bevacizumab Biosimilar for Five Cancer Types
ON JUNE 28, the U.S. Food and Drug Administration (FDA) approved bevacizumab-bvzr (Zirabev), a biosimilar to bevacizumab (Avastin), for the treatment of five types of cancer: metastatic colorectal cancer; unresectable, locally advanced, recurrent, or metastatic nonsquamous non–small cell lung...
FDA Expands Indication for Pembrolizumab to Metastatic Small Cell Lung Cancer
ON JUNE 17, the U.S. Food and Drug Administration (FDA) granted accelerated approval to the anti– programmed cell death protein 1 (PD-1) therapy pembrolizumab (Keytruda) as monotherapy for patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based...
FDA Grants Accelerated Approval to Selinexor in Combination With Dexamethasone in Pentarefractory Multiple Myeloma
On July 3, the U.S. Food and Drug Administration (FDA) granted accelerated approval to selinexor (Xpovio) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two ...
FDA Requests Manufacturer Recall of Some Textured Breast Implants
Today, the U.S. Food and Drug Administration (FDA) requested that Allergan, the manufacturer of a specific type of textured breast implant, recall specific models of its textured implants from the U.S. market due to the risk of breast implant–associated anaplastic large cell lymphoma (ALCL)....
FDA Approves Rituximab Biosimilar for Non-Hodgkin Lymphoma, CLL, and Autoimmune Conditions
Today, the U.S. Food and Drug Administration (FDA) approved rituximab-pvvr (Ruxience), a biosimilar to rituximab (Rituxan), for the treatment of adult patients with non-Hodgkin lymphoma, chronic lymphocytic leukemia (CLL), and granulomatosis with polyangiitis and microscopic polyangiitis....
FDA Approves Daratumumab in Combination With Lenalidomide and Dexamethasone for Newly Diagnosed Multiple Myeloma
On June 27, the U.S. Food and Drug Administration (FDA) approved daratumumab (Darzalex) in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). The application received...
Brentuximab Vedotin in Untreated Systemic Anaplastic Large-Cell Lymphoma and CD30-Expressing Peripheral T-Cell Lymphomas
On November 16, 2018, brentuximab vedotin was approved for use in combination with chemotherapy for previously untreated systemic anaplastic large-cell lymphoma or other CD30-expressing peripheral T-cell lymphomas (PTCLs), including angioimmunoblastic T-cell lymphoma and PTCL–not otherwise...
FDA Grants Breakthrough Therapy Designation to Pembrolizumab Plus Lenvatinib in Advanced HCC
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to the programmed cell death protein 1 inhibitor pembrolizumab in combination with the multiple kinase inhibitor lenvatinib for the potential first-line treatment of patients with advanced unresectable...
Fragility Analysis of Phase III Trials Supporting FDA Approval of Anticancer Drugs
In an analysis reported in The Lancet Oncology, Del Paggio and Tannock found that many phase III trials supporting U.S. Food and Drug Administration (FDA) approval of anticancer drugs have a low fragility index—a measure of how many people in a study would have had to have a different outcome ...
FDA Pipeline: Designations and Applications Granted in Lymphoma, Small Cell Lung Cancer, Multiple Myeloma, and More
Recently, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to a phospholipid-drug conjugate in diffuse large B-cell lymphoma; granted Orphan Drug designation to an immunotherapy for small cell lung cancer (SCLC); accepted supplemental biologics license applications (sBLAs) ...
Friends of Cancer Research Launches Next Phase in Real-World Evidence Initiative
Friends of Cancer Research (Friends) is launching the next phase of its Real-World Evidence (RWE) pilot project after a broad stakeholder meeting in February 2019. At the meeting, the U.S. Food and Drug Administration (FDA) and various data partners expressed interest in...
How Immunologic Dysregulation in the Multiple Myeloma Microenvironment May Affect Response to CAR T-Cell Therapy
Despite an avalanche of novel therapies approved by the U.S. Food and Drug Administration (FDA) over the past decade in the treatment of multiple myeloma, including proteasome inhibitors and immunomodulatory drugs, this blood cancer remains largely incurable, and nearly 13,000 people are expected...
FDA Approves New Trastuzumab Biosimilar
On June 14, the U.S. Food and Drug Administration (FDA) approved trastuzumab-anns (Kanjinti) for all approved indications of the reference product trastuzumab (Herceptin): for the treatment of HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction...
Trifluridine/Tipiracil in Recurrent, Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma
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 February 22, trifluridine/tipiracil...
FDA Approves First-Line Ivosidenib for IDH1-Mutated AML
On May 2, the U.S. Food and Drug Administration (FDA) expanded its approval of ivosidenib (Tibsovo) to include newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved test, in patients who are at least 75 years old or who have comorbidities that ...
Benefit Seen With Targeted Therapies in Elderly and Medically Complex Patients With Metastatic RCC
Many elderly and medically complex patients with metastatic renal cell carcinoma (RCC)—who are often underrepresented in clinical trials—saw overall survival benefits from treatment with targeted therapies, according to a study that analyzed 13 years of data on Medicare patients...
Role of Liquid Biopsy in Lymphoma
In this episode, The ASCO Post's Editor-in-Chief Dr. James Armitage talks about the International Conference on Malignant Lymphoma (ICML), which he attended recently in Lugano, Switzerland; in particular, Dr. Armitage shares insight from a workshop on bridging liquid biopsy into the management of...
FDA Grants Accelerated Approval to Selinexor in Combination With Dexamethasone in Pentarefractory Multiple Myeloma
Today, the U.S. Food and Drug Administration (FDA) granted accelerated approval to selinexor (Xpovio) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two...
Combination Immunotherapy and Inhibitors of DNA Damage Repair in the Treatment of Small Cell Lung Cancer
Unlike non–small cell lung cancer (NSCLC), which has seen a paradigm shift in treatment modalities with the discovery of genetic signatures (including EGFR mutations) that are responsive to targeted drugs, systemic treatment of small cell lung cancer (SCLC) has remained largely unchanged for over...
Study Shows Benefit With Pazopanib in Treatment of Carcinoid Tumors
Pazopanib significantly improved progression-free survival by 47% in patients with progressive carcinoid tumors, in a prospective randomized phase II trial presented at the 2019 ASCO Annual Meeting.1 “With these results, Alliance A021202 becomes the first randomized study to show that the vascular...
SNMMI 2019: Vest to Personalize Lu-177 Dotatate Therapy for Neuroendocrine Tumors
Researchers at the University of Washington are developing a user-friendly vest with technology that collects data to tailor personalized therapy for patients with metastatic, somatostatin receptor 2–positive neuroendocrine tumors (NETs). Their study was presented at the 2019 Annual Meeting...
Project Facilitate: FDA’s Plan to Ease Expanded Access to Novel Therapies
The U.S. Food and Drug Administration (FDA) plans to provide oncologists with greater help in acquiring expanded access to investigational therapies. Deemed Project Facilitate, the pilot program was announced at a press briefing during the 2019 ASCO Annual Meeting. Project Facilitate is essentially ...
FDA Pipeline: Applications Accepted in Gynecologic Cancers, Targeted Therapies
Recently, the U.S. Food and Drug Administration (FDA) accepted a new drug application for niraparib in the treatment of certain pretreated gynecologic cancers; granted Fast Track designation to a T-cell product; accepted investigational new drug applications for a myelopreservation agent and an...
FDA Approves Bevacizumab Biosimilar for Five Cancer Types
On June 28, the U.S. Food and Drug Administration (FDA) approved bevacizumab-bvzr (Zirabev), a biosimilar to bevacizumab (Avastin), for the treatment of five types of cancer: metastatic colorectal cancer; unresectable, locally advanced, recurrent, or metastatic nonsquamous non–small cell ...
FDA Approves Daratumumab in Combination With Lenalidomide and Dexamethasone for Newly Diagnosed, Transplant-Ineligible Patients With Multiple Myeloma
Today, the U.S. Food and Drug Administration (FDA) approved daratumumab (Darzalex) in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). The application received approval ...
Accelerated Approval Program: For the Benefit of Patients
A DIAGNOSIS of any life-threatening cancer or other serious illness has always been a world-shaking event for those touched by significant disease, and most of us have known—or will know—the frustration, helplessness, and desperate sense of urgency provoked by the words, “The disease is worsening,...
Trainee and Early-Career Members: Tips for Maximizing Your Benefit From ASCO Membership
ASCO is one of the premier professional societies that is guiding oncologists throughout the world. Whether you are a medical student or an early-career oncologist, ASCO has a lot to offer. A main focus of ASCO is to promote and provide guidance to trainees and early-career oncologists. I consider...
Register Early for ASCO’s Research Community Forum 2019 Annual Meeting
EARLY REGISTRATION is now 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...
Improved Survival Shown With First-Line Pembrolizumab in Advanced Head and Neck Cancer
In the final analysis of KEYNOTE-048, first-line pembrolizumab monotherapy led to a significant improvement in overall survival, vs standard chemotherapy with targeted therapy (EXTREME regimen), in patients with recurrent or metastatic head and neck squamous cell carcinoma expressing programmed...
FDA Approves Pembrolizumab for the First-Line Treatment of Head and Neck Squamous Cell Carcinoma
On June 10, the U.S. Food and Drug Administration (FDA) approved the anti–programmed cell death protein 1 immunotherapy pembrolizumab (Keytruda) for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma. Pembrolizumab was approved for...
FDA Announces Project Facilitate to Access Investigational Therapies for Patients With Cancer
The Oncology Center of Excellence of the U.S. Food and Drug Administration (FDA) recently announced a new pilot program to assist oncology health-care professionals in requesting access to unapproved therapies for patients with cancer. A new call center designated Project Facilitate will be a...
Darolutamide in Nonmetastatic Castration-Resistant Prostate Cancer: Delaying Overt Metastatic Disease Is a Major Advance
Nonmetastatic (M0) castration-resistant prostate cancer arises in the subset of men with biochemically recurrent disease (ie, rising prostate-specific antigen [PSA] level after definitive therapy in the absence of metastases) who develop PSA progression after chronic exposure to...
2019 ASCO: Resection of Liver Metastases
In this episode, we discuss more news from the ASCO Annual Meeting, including findings from a study with relevance to surgical oncology, a summary of a study in HER2-positive breast cancer, and a third study on discrimination among hematology/oncology fellows. We also discuss two FDA approvals that ...
FDA Expands Indications for Pembrolizumab to Include Metastatic SCLC With Disease Progression on or After Other Therapies
On June 17, the U.S. Food and Drug Administration (FDA) granted accelerated approval to the anti–programmed cell death protein 1 (PD-1) therapy pembrolizumab (Keytruda) as monotherapy for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease...
FDA Approves New Trastuzumab Biosimilar
Today, the U.S. Food and Drug Administration (FDA) approved trastuzumab-anns (Kanjinti) for all approved indications of the reference product trastuzumab (Herceptin): for the treatment of HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal...
FDA Pipeline: Designations and Reviews in Myelofibrosis, Myelodysplastic Syndromes, Biliary Tract Cancer, and T-Cell Receptor Therapy
Recently, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for momelotinib in myelofibrosis, granted Priority Review to a biologics license application for luspatercept in myelodyslastic syndromes and beta-thalassemia, granted Orphan Drug designation for a new chemical...
2019 ASCO: Pancreatic, Urothelial, and Cervical Cancers
In this episode, we discuss more news from the ASCO Annual Meeting, sharing interviews with experts on studies in pancreatic, urothelial, and cervical cancers. We’ll also tell you about a couple of new drug approvals announced this week by the FDA.
Hani M. Babiker, MD, on Tumor Treating Fields: A Different Approach to Therapy
Hani M. Babiker, MD, of the The University of Arizona, discusses an emerging treatment that inhibits the mitotic spindle and disrupts tumor cell growth. The method has been approved by the FDA to treat some cancers and data show improved progression-free and overall survival (Abstracts 2055, 8551,...
FDA Approves Pembrolizumab for the First-Line Treatment of Head and Neck Squamous Cell Carcinoma
On June 10, the U.S. Food and Drug Administration (FDA) approved the anti–programmed cell death protein 1 immunotherapy pembrolizumab (Keytruda) for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma. Pembrolizumab was...
FDA Approves Polatuzumab Vedotin-piiq in Combination With Bendamustine and a Rituximab Product for DLBCL
On June 10, the U.S. Food and Drug Administration (FDA) granted accelerated approval to polatuzumab vedotin-piiq (Polivy), a CD79b-directed antibody-drug conjugate, in combination with bendamustine and a rituximab product for adult patients with relapsed or refractory diffuse large B-cell lymphoma...
Selected Abstracts From the 2019 ASCO Annual Meeting
To complement The ASCO Post’s comprehensive coverage of the 2019 ASCO Annual Meeting, here are several abstracts selected from the meeting proceedings focusing on novel therapeutic regimens for plasma cell dyscrasias, particularly multiple myeloma. For full details of these study abstracts, visit ...
FDA Pipeline: Reviews and Designations in Multiple Myeloma, Lymphoma, Prostate Cancer
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review for daratumumab in combination with a triplet therapy in multiple myeloma, Breakthrough Therapy designation to copanlisib for marginal zone lymphoma, and Fast Track designation for ARV-110 in metastatic...
Selected Studies From the 2019 ASCO Annual Meeting
In this debut episode of The ASCO Post Podcast, experts in breast, prostate, and lung cancers and multiple myeloma provide clinical insights about selected studies presented at the recent ASCO Annual Meeting, plus news from the FDA.
Ruxolitinib Approved for Acute Graft-vs-Host Disease
On May 24, the U.S. Food and Drug Administration (FDA) approved ruxolitinib (Jakafi) for steroid-refractory acute graft-vs-host disease (GVHD) in adult and pediatric patients 12 years and older. Approval was based on the REACH1 trial/Study INCB 18424-271, an open-label, single-arm, multicenter...
