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Showing 2101 - 2150Evidence-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...
FDA Approves Fulvestrant in Combination With Abemaciclib in Hormone Receptor–Positive, HER2-Negative Advanced Breast Cancer
Today, the U.S. Food and Drug Administration (FDA) approved a new indication for fulvestrant (Faslodex), expanding the drug's approved use to include combined therapy with abemaciclib (Verzenio), a cyclin-dependent kinase (CDK) 4/6 inhibitor, for the treatment of hormone receptor–positive,...
FDA Authorizes MSK-IMPACT Tumor Profiling Assay
Today, the U.S. Food and Drug Administration (FDA) authorized Memorial Sloan Kettering Cancer Center’s MSK-IMPACT tumor profiling assay, an in vitro diagnostic test that can identify more biomarkers that may be found in various cancers than any test previously reviewed by the...
Ventana MMR IHC Panel for Patients Diagnosed With Colorectal Cancer Receives FDA Clearance
On November 14, the U.S. Food & Drug Administration (FDA) granted clearance to the Ventana MMR IHC Panel, which provides clinicians with a comprehensive group of immunohistochemistry (IHC) tests for patients diagnosed with colorectal cancer. The tests detect proteins associated with the DNA...
FDA Grants Regular Approval of Dasatinib for Pediatric Philadelphia Chromosome–Positive CML in Chronic Phase
On November 9, the U.S. Food and Drug Administration (FDA) expanded the indication for dasatinib (Sprycel) tablets to include the treatment of children with Philadelphia chromosome–positive chronic myeloid leukemia (CML) in chronic phase (CP).This approval for dasatinib in pediatric patients...
FDA Approves Brentuximab Vedotin for Primary Cutaneous Anaplastic Large Cell Lymphoma
Today, the U.S. Food and Drug Administration (FDA) granted regular approval to brentuximab vedotin (Adcetris) for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides who have received prior systemic therapy. ALCANZA...
FDA Approves Letermovir for Prophylaxis of Cytomegalovirus Infection and Disease in Allogeneic Stem Cell Transplant Patients
Today, the U.S. Food and Drug Administration (FDA) approved letermovir (Prevymis) once-daily tablets for oral use and injection for intravenous infusion. Letermovir is indicated for prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients of an allogeneic...
FDA Approves Intravenous Rolapitant for Prevention of Delayed Chemotherapy-Induced Nausea and Vomiting
ON OCTOBER 25, the U.S. Food and Drug Administration (FDA) approved intravenous (IV) rolapitant (Varubi) in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including...
Balancing Immune-Related Adverse Events With Efficacy of Dual Checkpoint Inhibitor Therapy in Melanoma
MUCH PROGRESS has been made in the past decade in the treatment of patients with newly diagnosed metastatic melanoma. In the front-line setting, programmed cell death protein 1 (PD-1) monotherapy (nivolumab [Opdivo] and pembrolizumab [Keytruda]) and combined PD-1 plus cytotoxic...
FDA Approves Alectinib for ALK-Positive Metastatic NSCLC
On November 6, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to alectinib (Alecensa) for treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non–small cell lung cancer (NSCLC), as detected by an FDA-approved test. In December 2015,...
FDA Approves Vemurafenib for Certain Patients With Erdheim-Chester Disease
On November 6, the U.S. Food and Drug Administration (FDA) expanded the approval of vemurafenib (Zelboraf) to include the treatment of certain adult patients with Erdheim-Chester disease (ECD), a rare cancer of the blood. Vemurafenib is indicated to treat patients whose cancer cells have a specific ...
FDA Accepts sBLA for Bevacizumab as a Front-Line Treatment for Advanced Ovarian Cancer
On October 25, Genentech announced that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental Biologics License Application (sBLA) for bevacizumab (Avastin) in combination with chemotherapy (carboplatin and paclitaxel), followed by bevacizumab alone, for the front-line ...
New Biosimilar Educational Materials for Health-Care Professionals From the FDA
The U.S. Food and Drug Administration (FDA) has announced the release of new educational materials for health-care professionals about biosimilar and interchangeable products. The agency developed these educational materials to help increase understanding about these important new types of...
Immunotherapeutic Approaches for B-Cell Acute Lymphocytic Leukemia
New therapeutic agents for acute lymphocytic leukemia (ALL) have led to dramatic improvement in remission rates, but questions concerning the proper sequencing and combination of these agents remain. At the National Comprehensive Cancer Network® (NCCN®) 13th Annual Congress: Hematologic...
FDA Approves Novel Therapies for Lymphoma Indications
IN OCTOBER, the U.S. Food and Drug Administration (FDA) approved two novel agents for lymphoma indications: -acalabrutinib (Calquence), a kinase inhibitor, for the treatment of adults with mantle cell lymphoma who have received at least one prior therapy; and axicabtagene ciloleucel (Yescarta), a...
Adjuvant Dabrafenib/Trametinib Combination Granted FDA Breakthrough Therapy Designation for Stage III Melanoma With BRAF V600 Mutation
On October 23, Novartis announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for dabrafenib (Tafinlar) in combination with trametinib (Mekinist) for the adjuvant treatment of patients with stage III melanoma with a BRAF V600 mutation following...
FDA Approves New Treatment for Adults With Mantle Cell Lymphoma
The U.S. Food and Drug Administration (FDA) today granted accelerated approval to acalabrutinib (Calquence) for the treatment of adults with mantle cell lymphoma who have received at least one prior therapy. “Mantle cell lymphoma is a particularly aggressive cancer,” said Richard...
AACR-NCI-EORTC: Rising Number of Seamless Clinical Trials in Oncology
The number of early-phase trials in oncology that adopted a seamless approach—as opposed to a traditional trial approach with defined phase I, II, and III plans—is rising, with data from the majority of them presented after 2014, according to a study presented by Barata et al at the...
FDA Approves Axicabtagene Ciloleucel for Large B-Cell Lymphoma
On October 18, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to axicabtagene ciloleucel (Yescarta) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma...
New Biosimilar Educational Materials for Health-Care Professionals From the FDA
The U.S. Food and Drug Administration (FDA) has announced the release of new educational materials for health-care professionals about biosimilar and interchangeable products. The agency developed these educational materials to help increase understanding about these important new types of...
FDA Accepts sBLA for Nivolumab in Resected, High-Risk, Advanced Melanoma
On October 16, Bristol-Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review its supplemental Biologics License Application (sBLA) for nivolumab (Opdivo) to treat patients with melanoma who are at high risk of disease recurrence following complete...
FDA Approves Intravenous Rolapitant for Delayed Chemotherapy-Induced Nausea and Vomiting
On October 25, the U.S. Food and Drug Administration (FDA) approved intravenous (IV) rolapitant (Varubi) in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including,...
CELESTIAL Trial: Cabozantinib Meets Primary Endpoint of Overall Survival in Patients With Advanced Hepatocellular Carcinoma
On October 16, Exelixis announced that its global phase III CELESTIAL trial met its primary endpoint of overall survival, with cabozantinib (Cabometyx) providing a statistically significant and clinically meaningful improvement in median overall survival compared to placebo in patients with...
FDA Grants Priority Review for Olaparib in Metastatic Breast Cancer
On October 18, AstraZeneca and Merck & Co announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to a supplemental New Drug Application (sNDA) for the use of olaparib (Lynparza) tablets in patients with germline BRCA-mutated, HER2-negative...
Register for December 1 FDA Workshop on Cardiovascular Toxicities in Immunotherapy Trials
THE U.S. FOOD & DRUG ADMINISTRATION (FDA) and the Oncology Center of Excellence (OCE) will host a complimentary public workshop, Assessment of Cardiovascular Toxicities in Immuno-Oncology Trials, on December 1. ASCO is supporting the workshop with the American College of Cardiology (ACC), the...
FDA Accepts sBLA for Durvalumab in Locally Advanced Unresectable NSCLC
On October 17, the U.S. Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for durvalumab (Imfinzi) for the treatment of patients with locally advanced (stage III) unresectable non–small cell lung cancer (NSCLC) whose disease has not progressed ...
