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Showing 1501 - 1550FDA Pipeline: Priority Reviews in Prostate Cancer, Mantle Cell Lymphoma
This week, the U.S. Food and Drug Administration (FDA) accepted new drug applications for enzalutamide in metastatic hormone-sensitive prostate cancer and zanubrutinib in relapsed or refractory mantle cell lymphoma, and granted both applications Priority Review. Priority Review for Enzalutamide in ...
Pexidartinib for Tenosynovial Giant Cell Tumor
On August 2, the oral colony-stimulating factor 1 receptor inhibitor pexidartinib was approved for treatment of adult patients with symptomatic tenosynovial giant cell tumor associated with severe morbidity or functional limitations and not amenable to improvement with surgery.1,2 It is the first...
FDA 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 esophageal cancer whose tumors express programmed cell death ligand 1...
Atezolizumab Plus Chemotherapy and Bevacizumab in First-Line Treatment of Metastatic Lung Cancer
In late 2018, atezolizumab was approved for use in combination with bevacizumab, paclitaxel, and carboplatin for the first-line treatment of patients with metastatic nonsquamous non–small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberration.1,2 Supporting Efficacy Data Approval was ...
Racial Reporting and Representation in Oncology Trials
New research published by Loree et al in JAMA Oncology found that race and race subgroup analysis reporting does not occur frequently and that black and Hispanic populations are underrepresented in oncology trials that have led to U.S. Food and Drug Administration (FDA) approvals. The study raises...
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...
FDA Pipeline: Designation in CLL, New Drug Application in GIST, New Prostate Ablation System Receives 510(k) Clearance
Recently, the U.S. Food and Drug Administration granted Breakthrough Therapy designation to acalabrutinib in chronic lymphocytic leukemia (CLL), accepted a new drug application for avapritinib in some types of gastrointestinal stromal tumors (GIST), and granted 501(k) clearance to market the...
FDA Approves Fedratinib for Myelofibrosis
Today, the U.S. Food and Drug Administration (FDA) approved fedratinib (Inrebic) for adults with intermediate-2 or high-risk primary or secondary (postpolycythemia vera or postessential thrombocythemia) myelofibrosis. “Prior to today, there was one FDA-approved drug to treat patients with...
FDA Approves Entrectinib for NTRK-Fusion Cancers, ROS1-Positive NSCLC
Today, 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 Review Finds No Increased Risk of Prostate Cancer With Parkinson's Disease Treatments Containing Entacapone
A U.S. Food and Drug Administration (FDA) review of additional data found no increased risk of prostate cancer with the use of entacapone to treat Parkinson’s disease. The FDA conducted this review after an earlier trial—the Stalevo Reduction in Dyskinesia Evaluation–Parkinson's...
Remembering Michael D. Becker
The staff of The ASCO Post were sad to learn of the passing of Michael D. Becker on July 9, 2019. When Michael was diagnosed with human papillomavirus (HPV)-related oropharyngeal cancer in 2015, he made the decision to go public with his diagnosis to raise awareness of the importance of having...
Pembrolizumab for Advanced Merkel Cell Carcinoma
Late in 2018, pembrolizumab was granted accelerated approval in the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma.1,2 Supporting Efficacy Data Approval was based on Cancer Immunotherapy Trials Network protocol 9 (CITN-09), also known...
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...
Polatuzumab Vedotin-piiq for Relapsed or Refractory Diffuse Large B-Cell Lymphoma
On June 10, 2019, the CD79b-directed antibody-drug conjugate polatuzumab vedotin-piiq was granted accelerated approval for use in combination with bendamustine and a rituximab product for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified,...
COTA Signs Research Collaboration Agreement With FDA
COTA, Inc, a precision medicine technology company, announced that it has signed a 2-year Research Collaboration Agreement with the U.S. Food and Drug Administration (FDA) Information Exchange and Data Transformation (INFORMED) Program, the Agency’s data science and technology incubator that...
Pembrolizumab in Metastatic Small Cell Lung Cancer
On June 17, 2019, pembrolizumab was granted accelerated approval for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy.1,2 Supporting Efficacy Data Approval was based...
Preserving Sexuality and Restoring Sexual Function in Male and Female Cancer Survivors
Intimacy changes after a cancer diagnosis. Both male and female survivors can experience significant sexual dysfunction, pain with sex, loss of desire, and a slew of other clinical and psychological sequelae. To make matter worse, sexual function is often not discussed by patients and their...
Atezolizumab Combined With Chemotherapy in First-Line Extensive-Stage Small Cell Lung Cancer
On March 18, 2019, atezolizumab was approved for use in combination with carboplatin and etoposide in the first-line treatment of adult patients with extensive-stage small cell lung cance (SCLC).1,2 Supporting Efficacy Data Approval was based on findings in the phase III double-blind IMpower133...
Global Coalition for Adaptive Research in Glioblastoma
The Global Coalition for Adaptive Research (GCAR) announced recently that the GBM AGILE clinical trial is opening its first clinical site, the Henry Ford Cancer Institute, and has begun enrolling patients. GBM AGILE is the world’s first global adaptive clinical trial platform for glioblastoma and...
FDA Requests Manufacturer Recall of Some Textured Breast Implants
On July 24, 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
On July 24, 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 polyangi-itis....
Notable Presentations at ASCO 2019 Included Studies in Sarcoma, Lymphoma, Myeloma, and Breast and Kidney Cancers
The 2019 ASCO Annual Meeting featured a wealth of presentations on important topics. In addition to our regular news coverage of the meeting, we present below some highlights of other studies that add to our knowledge base for treatment of various cancers. Olaratumab in Soft-Tissue Sarcoma...
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 (TGCT) associated with severe morbidity or functional limitations and not responsive to improvement with...
FDA Pipeline: Breakthrough Therapy for Melanoma, Investigational New Drug for Advanced Solid Tumors
This week, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to bempegaldesleukin in combination with nivolumab for advanced melanoma and cleared an investigational new drug application for a phase I trial of SB 11285 in advanced solid tumors. Breakthrough...
Overall Survival in MONALEESA-7
This week, we discuss an interim analysis of the MONALEESA-7 trial of the addition of ribociclib to endocrine therapy in pre- or perimenopausal women with advanced hormone receptor–positive, HER2-negative breast cancer. We also talk about a study that examined the relationship between the duration...
FDA 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...
