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Showing 2101 - 2150Nivolumab for Adjuvant Treatment of Melanoma Granted Regular Approval by FDA
On December 20, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to the anti–programmed cell death protein 1 (PD-1) monoclonal antibody nivolumab (Opdivo) for the adjuvant treatment of patients with melanoma with involvement of lymph nodes, or in patients with...
FDA Grants Regular Approval to Pertuzumab for Adjuvant Treatment of HER2-Positive Breast Cancer
On December 20, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to pertuzumab (Perjeta) for use in combination with trastuzumab (Herceptin) and chemotherapy as adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence. APHINITY...
FDA Approves Cabozantinib for First-Line Treatment of Advanced Renal Cell Carcinoma
On December 19, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to cabozantinib (Cabometyx) for treatment of patients with advanced renal cell carcinoma (RCC). The FDA previously approved cabozantinib in 2016 for treatment of patients with advanced RCC who have received...
FDA Grants Accelerated Approval to Bosutinib for Treatment of Newly Diagnosed Philadelphia Chromosome–Positive CML
On December 19, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to bosutinib (Bosulif) for treatment of patients with newly diagnosed chronic-phase Philadelphia chromosome–positive chronic myelogenous leukemia (CML). BFORE Trial Approval was based on data from ...
FDA Accepts sNDA for Osimertinib in First-Line Treatment of EGFR-Mutated NSCLC
On December 18, the U.S. Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) for the use of osimertinib (Tagrisso)—a third-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor with clinical activity against central...
Updated Data in KEYNOTE-061: Pembrolizumab in Previously Treated Gastric or Gastroesophageal Junction Adenocarcinoma
The phase III KEYNOTE-061 trial investigating pembrolizumab (Keytruda) as a second-line treatment for patients with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma did not meet its primary endpoint of overall survival (OS) (hazard ratio [HR] = 0.82, 95% confidence interval [CI] = ...
FDA Accepts sNDA for Rucaparib in Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
On December 5, Clovis Oncology announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for rucaparib (Rubraca) and granted Priority Review status to the application, with a Prescription Drug User Fee Act (PDUFA) date of April 6, 2018. In...
FDA Accepts sBLA for Nivolumab Plus Ipilimumab in Intermediate- and Poor-Risk Patients With Advanced Renal Cell Carcinoma
On December 13, the U.S. Food and Drug Administration (FDA) accepted a supplemental Biologics License Application (sBLA) for priority review of nivolumab (Opdivo) plus ipilimumab (Yervoy) to treat intermediate- and poor-risk patients with advanced renal cell carcinoma. The FDA also previously...
ASH 2017: Acalabrutinib Demonstrates Activity in Relapsed or Refractory Mantle Cell Lymphoma
At the 59th American Society of Hematology (ASH) Annual Meeting & Exposition, Wang et al presented results from the open-label, single-arm phase II ACE-LY-004 clinical trial, which served as the basis for the recent U.S. Food and Drug Administration (FDA) accelerated approval of acalabrutinib...
ASH 2017: People Aged 75 Years and Older Are Underrepresented in Blood Cancer Clinical Trials
In the first comprehensive analysis of clinical trial enrollment among older adults with blood cancers, researchers from the U.S. Food and Drug Administration (FDA) found significant gaps in participation among those aged 75 and older when considered against the incidence of these malignancies in...
ASH 2017: Targeted Antibody Mogamulizumab Superior to Vorinostat for Previously Treated CTCL in Phase III Trial
In a large, international, randomized phase III trial presented by Kim et al at the 59th American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 817), patients with previously treated cutaneous T-cell lymphoma (CTCL) who received the investigational targeted drug...
Lynn J. Howie, MD, on ER+ Metastatic Breast Cancer: An FDA Treatment Analysis
Lynn J. Howie, MD, of the U. S. Food & Drug Administration, discusses a pooled analysis of outcomes of older women with hormone receptor–positive metastatic breast cancer treated with a CDK4/6 inhibitor as initial endocrine-based therapy (Abstract GS5-06).
SABCS 2017: Older Women With Hormone Receptor–Positive Breast Cancer May Receive Similar Benefit From CDK4/6 Inhibitors as Younger Women
Older women with hormone receptor–positive, HER2-negative metastatic breast cancer who were treated with cyclin-dependent kinase (CDK) 4/6 inhibitors achieved progression-free survival at a rate similar to that of younger women, according to data presented by Singh et al at the 2017 San...
FDA Announces Approval, CMS Proposes Coverage of Diagnostic Test for Cancer Biomarkers
On November 30, the U.S. Food and Drug Administration (FDA) approved CDx (F1CDx), a breakthrough-designated, next-generation sequencing–based in vitro diagnostic test that can detect genetic mutations in 324 genes and 2 genomic signatures in any solid tumor type. The Centers for Medicare &...
FDA Approves First Biosimilar for the Treatment of Certain Breast and Stomach Cancers
On December 1, 2017, the U.S. Food and Drug Administration (FDA) approved trastuzumab-dkst (Ogivri) as a biosimilar to trastuzumab (Herceptin) for the treatment of patients with breast or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors overexpress the HER2 gene. The...
Liposome-Encapsulated Daunorubicin and Cytarabine for AML Subtypes
On August 3, 2017, a liposome-encapsulated combination of daunorubicin and cytarabine (Vyxeos) was approved for treatment of adults with newly diagnosed therapy-related acute myeloid leukemia (AML) or AML with myelodysplasia-related changes.1,2 This is the first U.S. Food and Drug...
Ibrutinib in Chronic Graft-vs-Host Disease
On August 2, 2017, ibrutinib (Imbruvica) was approved for treatment of adult patients with chronic graft-vs-host disease after failure of one or more lines of systemic therapy.1,2 This is the first U.S. Food and Drug Administration (FDA)-approved therapy for treatment of chronic graft-vs-host...
Future Directions for CAR T-Cell Therapy
Chimeric antigen receptor (CAR) T-cell therapy burst upon the scene as an innovative approach to the treatment of hematologic malignancies, mainly for patients who have exhausted all other treatment options. Recently two CAR T-cell products were approved by the U.S. Food and Drug Administration...
Olaparib Tablets for Maintenance Treatment in Ovarian Cancer
On August 17, 2017, olaparib -(Lynparza) in tablet form was granted regular approval for maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy.1,2 Olaparib...
Dasatinib in Pediatric Patients With Chronic Myeloid Leukemia
On November 9, 2017, dasatinib (Sprycel) was granted regular approval for treatment of pediatric patients with Philadelphia chromosome–positive chronic myeloid leukemia (CML) in chronic phase.1,2 Supporting Efficacy Data Approval was based on findings among 97 pediatric patients with chronic-phase...
Follicular Lymphoma: Is the Road to Cure Paved With Gallium?
The roadside along the path to curing follicular lymphoma is riddled with the debris of failed cytotoxic regimens. For decades, clinical trials unsuccessfully pitted various chemotherapy combinations against each other. It took but a single, noncytotoxic molecule, rituximab (Rituxan), to forever...
Vemurafenib in Erdheim-Chester Disease
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 November 6, 2017, vemurafenib (Zelboraf) was granted...
Shifting Landscape of Oncology Drug Development and Approvals
Future oncology drug development and approvals will be faster and more efficient as well as take the patient experience more into account, said Richard Pazdur, MD, Director of the Oncology Center of Excellence at the U.S. Food and Drug Administration (FDA). The Center was established as part of...
Preparing for Steep Increase in Breast Cancer Among the Elderly
“We are in the midst of a steep increase” in the incidence of breast cancer among women aged 65 years and older, Arti Hurria, MD, reported at the 19th Annual Lynn Sage Breast Cancer Symposium, Chicago.1 “Are we prepared as a health-care system and as providers to address this burgeoning need?” she...
CAR T-Cell Therapy Makes Further Inroads in Lymphoma and Myeloma
With the recent U.S. Food and Drug Administration (FDA) approvals of two chimeric antigen receptor (CAR) T-cell products, this novel approach seems to be moving into the mainstream. The approvals were tisagenlecleucel (also known as CTL019; Kymriah) for the treatment of pediatric B-cell acute...
Evidence-Based Support for Triplet Therapies in Multiple Myeloma
Over the past 15 years, multiple myeloma has garnered among the highest number of regulatory approvals by the U.S. Food and Drug Administration (FDA) for the management of all phases of the disease. This fast-expanding repertoire of treatment options has pushed the median survival of multiple...
SABCS 40th Anniversary Award Lecture: Richard Pazdur, MD, on Cancer Drug Development
Richard Pazdur, MD, of the U.S. Food & Drug Administration’s Oncology Center of Excellence, discusses the rapid changes in evaluating and approving new and effective agents, incorporating the view of patients in the process, and modernizing clinical trial design with broader eligibility...
FDA Grants Bevacizumab Full Approval in Recurrent Glioblastoma
On December 5, the U.S. Food and Drug Administration (FDA) granted full approval of bevacizumab (Avastin) for the treatment of adults with recurrent glioblastoma that has progressed following prior therapy. Bevacizumab was previously granted provisional approval in this setting under the FDA's ...
FDA Approves New Oral Solution for Colonoscopy Preparation
The U.S. Food and Drug Administration (FDA) has granted Ferring Pharmaceuticals Inc approval to market a combination sodium picosulfate, magnesium oxide, and anhydrous citric acid oral solution (Clenpiq) for cleansing the colon in adults undergoing a colonoscopy. With availability planned in...
FDA Approves Biosimilar for the Treatment of Certain Breast and Stomach Cancers
The U.S. Food and Drug Administration (FDA) today approved trastuzumab-dkst (Ogivri) as a biosimilar to trastuzumab (Herceptin) for the treatment of patients with breast or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors overexpress the HER2 gene. The drug is the first...
FDA Announces Approval, CMS Proposes Coverage of First Breakthrough-Designated Test to Detect Extensive Number of Cancer Biomarkers
On November 30, the U.S. Food and Drug Administration (FDA) approved the FoundationOne CDx (F1CDx), the first breakthrough-designated, next-generation sequencing–based in vitro diagnostic test that can detect genetic mutations in 324 genes and 2 genomic signatures in any solid tumor type. The ...
Climbing Costs for Treating Breast Cancer Poised to Strain Medicare in the Near Future
With cancer care costs projected to increase 32% from 2010 to 2020, researchers are working to determine the main drivers of costs for treating breast cancer. In a study led by Ami Vyas, PhD, MS, MBA, of the University of Rhode Island, published in the November issue of JNCCN–Journal of the...
FDA Approvals in November 2017: Novel Drugs, New Indications
THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) approved a number of novel drugs and new indications in November 2017. Several of them are listed here. Fulvestrant/Abemaciclib Combination in Breast Cancer ON NOVEMBER 15 , the FDA approved fulvestrant (Faslodex) in combination with abemaciclib...
Nivolumab in Hepatocellular Carcinoma Previously Treated With Sorafenib
ON SEPTEMBER 22, 2017, nivolumab (Opdivo) was granted accelerated approval for treatment of hepatocellular carcinoma in patients previously treated with sorafenib (Nexavar).1,2 Supporting Efficacy Data APPROVAL WAS based on findings in a 154-patient subgroup of the CheckMate 040 trial consisting...
NIH Partners With 11 Biopharmaceutical Companies on PACT Collaboration
On October 12, 2017, the National Institutes of Health (NIH) and 11 leading biopharmaceutical companies launched the Partnership for Accelerating Cancer Therapies (PACT), a 5-year public-private research collaboration totaling $215 million as part of the Cancer Moonshot. PACT will initially focus...
Tackling the High Cost of Cancer Care
AT THE 2017 ASCO ANNUAL MEETING, the leaders of the newly formed Value in Cancer Care Consortium (vi3c; vi3c.org) met to discuss the group’s plan to study how to improve the affordability of cancer drugs and make them more accessible to patients. The goal of the Value in Cancer Care Consortium is...
Pembrolizumab in Advanced Gastric Cancer
On September 22, 2017, pembrolizumab (Keytruda) was granted accelerated approval for treatment of recurrent locally advanced or metastatic, gastric or gastroesophageal junction adenocarcinoma with tumors expressing programmed cell death ligand 1 (PD-L1), as determined by a U.S. Food and Drug...
FDA Approves CAR T-Cell Therapy for Adults With Certain Types of Large B-Cell Lymphoma
ON OCTOBER 18, the U.S. Food and Drug Administration (FDA) approved axicabtagene ciloleucel (Yescarta), a cell-based gene therapy, to treat adult patients with certain types of large B-cell lymphoma who have not responded to or who have relapsed after at least two other kinds of treatment....
Brigatinib in Crizotinib-Pretreated Metastatic ALK-Positive Non–Small Cell Lung Cancer
On April 28, 2017, brigatinib (Alunbrig) was granted accelerated approval for the treatment of patients with metastatic anaplastic lymphoma kinase (ALK)-positive non–small cell lung cancer (NSCLC) who have had disease progression on or are intolerant to crizotinib (Xalkori).1,2 Supporting Efficacy...
Dabrafenib and Trametinib in BRAF V600E–Mutant Metastatic NSCLC
On June 22, 2017, regular approvals were granted to dabrafenib (Tafinlar) and trametinib (Mekinist) given in combination for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by a U.S. Food and Drug Administration (FDA)-approved...
Unraveling PD-L1 Assays in NSCLC: Are They Interchangeable?
With the availability of at least five checkpoint inhibitors to treat non–small cell lung cancer (NSCLC) and other solid tumors, appropriate patient selection for these expensive treatments remains key. The hope is that testing the level of programmed cell death ligand 1 (PD-L1) expression in tumor ...
Neratinib for Extended Adjuvant Treatment of Early-Stage HER2-Positive Breast Cancer
On July 17, 2017, neratinib (Nerlynx) a dual inhibitor of HER2 and epidermal growth factor receptor (EGFR), was approved for extended adjuvant treatment of adults with early-stage HER2-overexpressed/amplified breast cancer following adjuvant trastuzumab (Herceptin)-based therapy.1,2 Supporting...
Abemaciclib in Hormone Receptor–Positive, HER2-Negative Breast Cancer
On September 28, 2017, the cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor abemaciclib (Verzenio) was approved for use in combination with fulvestrant (Faslodex) for women with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer with disease progression following...
Copanlisib in Relapsed Follicular Lymphoma
On September 14, 2017, copanlisib (Aliqopa) was granted accelerated approval for treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies.1,2 Supporting Efficacy Data Approval was based on durable responses observed in a multicenter phase ...
Axicabtagene Ciloleucel for Large B-Cell Lymphoma
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 October 18, 2017, the chimeric antigen receptor (CAR)...
New Options for the Management of Hodgkin Lymphoma
With the vast majority of patients cured with primary therapy, classical Hodgkin lymphoma is largely a success story. For the 10% to 20% of patients who either relapse or are refractory to front-line therapy, the disease can still be fatal. At the National Comprehensive Cancer Network® (NCCN®) 12th ...
PARP Inhibitors in BRCA-Related Ovarian Cancer—and Beyond!
Poly (ADP ribose) polymerase (PARP) inhibitors are among the most exciting new classes of oncology drugs, and their development has coincided with the increasing recognition of the therapeutic vulnerability in targeting DNA damage response and DNA repair. The initial clinical testing of PARP...
FDA Approves Obinutuzumab for Previously Untreated Advanced Follicular Lymphoma
On November 16, Genentech announced that the U.S. Food and Drug Administration (FDA) approved obinutuzumab (Gazyva) in combination with chemotherapy, followed by obinutuzumab alone in those who responded, for people with previously untreated advanced follicular lymphoma (stage II bulky, III, or...
FDA Expands Approval of Sunitinib Malate for Adjuvant Treatment of Renal Cell Carcinoma After Nephrectomy
Today, the U.S. Food and Drug Administration (FDA) approved sunitinib malate (Sutent) for the adjuvant treatment of adult patients who are at a high risk of recurrent renal cell carcinoma after nephrectomy. “This is the first adjuvant treatment approved for patients with renal cell...
FDA Announces Comprehensive Regenerative Medicine Policy Framework
On November 16, the U.S. Food and Drug Administration (FDA) announced a comprehensive policy framework for the development and oversight of regenerative medicine products, including novel cellular therapies. The framework—outlined in a suite of four guidance documents—builds upon the...
