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Showing 1701 - 1750Larotrectinib for Solid Tumors With NTRK Gene Fusions
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 26, 2018, larotrectinib (Vitrakvi) was...
FDA Approves Olaparib for Maintenance Treatment of BRCA-Mutated, Advanced Ovarian Cancer
On December 19, 2018, the U.S. Food and Drug Administration (FDA) approved olaparib (Lynparza) for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer...
FDA Approves Pembrolizumab for Merkel Cell Carcinoma
Today, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) for adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma. The FDA’s approval was based on Cancer Immunotherapy Trials Network protocol 9...
Will the Trump Administration’s Plan to Reduce Cancer Drug Prices Work?
High drug prices are the number one health-care concern of many Americans. The average price of a cancer drug rose from less than $10,000/yr before 2000 to more than $170,000/yr in 2017.1-3 Between 1995 and 2013, the launch price of cancer drugs increased by 10% to 12% every year, and the average...
KATHERINE Trial: Adjuvant T-DM1 Reduces Invasive Disease Risk by 50% vs Trastuzumab in HER2-Positive Early Breast Cancer
In patients with HER2-positive early breast cancer and residual disease after neoadjuvant chemotherapy, adjuvant treatment with trastuzumab emtansine (T-DM1; Kadcyla) reduced the risk of invasive disease by 50% over trastuzumab (Herceptin).1 The phase III KATHERINE study was presented at the 2018...
FDA Approves Romiplostim for Pediatric Patients With Immune Thrombocytopenia
On December 14, 2018, the U.S. Food and Drug Administration (FDA) approved romiplostim (Nplate) for pediatric patients at least 1 year old with immune thrombocytopenia for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Approval was based ...
FDA Approves Trastuzumab-pkrb for HER2-Overexpressing Breast Cancer
On December 14, the U.S. Food and Drug Administration (FDA) approved trastuzumab-pkrb (Herzuma), a HER2/neu receptor antagonist biosimilar to trastuzumab (Herceptin), for the following indications: Adjuvant breast cancer of HER2 overexpressing node-positive or node-negative (estrogen...
ASCO and Friends of Cancer Research Applaud NCI’s Expansion of Clinical Trial Eligibility Criteria
ASCO and Friends of Cancer Research (Friends) applaud the National Cancer Institute's (NCI) recent revision of its clinical trial protocol template to broaden eligibility criteria for cancer clinical trials. The protocol template was expanded to help increase the opportunity for ...
FDA Pipeline: New Priority Reviews, Designations, and Clearances, Plus Statements on Genetic Testing and Class Labeling
The U.S. Food and Drug Administration (FDA) recently issued the following new approvals and designations: Priority Review for Atezolizumab in Combination With Chemotherapy for the Initial Treatment of Extensive-Stage SCLC The FDA accepted a supplemental biologics license application...
Moxetumomab Pasudotox-tdfk for Relapsed or Refractory Hairy Cell Leukemia
ON SEPTEMBER 13, 2018, moxetumomab pasudotox-tdfk (Lumoxiti), a CD22-directed cytotoxin, was approved for the treatment of adult patients with relapsed or refractory hairy cell leukemia who received at least two prior systemic therapies, including with a purine nucleoside analog.1,2 Supporting...
Encorafenib and Binimetinib: A New Benchmark in Metastatic Melanoma Therapy?
IN JULY 2018, the U.S. Food and Drug Administration (FDA) approved the combination of the oral BRAF inhibitor encorafenib (Braftovi) and the oral MEK inhibitor binimetinib (Mektovi) for BRAF V600E– or V600K– positive metastatic melanoma. The FDA approval was based on the results of the COLUMBUS...
Management of HER2-Positive Breast Cancer: Business as Usual?
MANAGEMENT OF HER2-positive breast cancer changed after the introduction of trastuzumab (Herceptin), the first anti-HER2 therapy to be approved by the U.S. Food and Drug Administration (FDA) for this type of cancer. Recent studies have more clearly defined the role of pertuzumab (Perjeta) and...
PARP Inhibitor Active in BRCA1/2-Mutated Metastatic Castration-Resistant Prostate Cancer
THE SEARCH for biomarkers in prostate cancer has proved frustrating, partly due to the complexity of the disease and its heterogeneity. A preliminary analysis of a phase II (TRITON2) study suggests that rucaparib (Rubraca), a poly (ADP-ribose) polymerase (PARP) inhibitor, may be active in men with...
FDA Approves Atezolizumab in Combination With Bevacizumab and Chemotherapy for First-Line Treatment of Metastatic, Nonsquamous NSCLC
On December 6, 2018, the U.S. Food and Drug Administration (FDA) approved atezolizumab (Tecentriq) in combination with bevacizumab (Avastin), paclitaxel, and carboplatin for the first-line treatment of patients with metastatic, nonsquamous non–small cell lung cancer (NSCLC) with no EGFR or...
Pembrolizumab With Chemotherapy for First-Line Treatment of Metastatic Nonsquamous NSCLC
On August 20, 2018, pembrolizumab (Keytruda) in combination with pemetrexed (Alimta) and platinum was granted regular approval as first-line treatment of patients with metastatic nonsquamous non–small cell lung cancer (NSCLC) with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma...
Talazoparib for Germline BRCA-Mutated HER2-Negative Advanced Breast Cancer
On October 16, 2018, the poly (ADP-ribose) polymerase (PARP) inhibitor talazoparib (Talzenna) was approved for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated, HER2-negative locally advanced or metastatic breast cancer.1,2 Patients must be selected for...
ASH 2018: Researchers Identify Mutation in BCL2 Protein That Causes Resistance to Venetoclax in Progressive CLL
Investigators from Australia have identified a genetic mutation that causes resistance to the targeted drug venetoclax (Venclexta) in patients with chronic lymphocytic leukemia (CLL), according to research presented by Blombery et al at the 2018 American Society of Hematology (ASH) Annual Meeting...
Lenvatinib in Unresectable Hepatocellular Carcinoma
On August 16, 2018, lenvatinib (Lenvima) was approved for the first-line treatment of patients with unresectable hepatocellular carcinoma.1,2 Supporting Efficacy Data Approval was based on the findings of a phase III open-label noninferiority trial (REFLECT), in which 954 patients with previously...
ASH 2018: Ibrutinib Plus Rituximab vs Standard Chemoimmunotherapy in Younger Patients With Treatment-Naive CLL
A 6-month course of chemotherapy-based treatment with FCR (intravenous fludarabine and cyclophosphamide plus rituximab [Rituxan]) has historically been the most effective treatment for chronic lymphocytic leukemia (CLL), especially in patients 70 years of age and younger. However, results from a...
ASH 2018: Update of ZUMA-1: Axicabtagene Ciloleucel in DLBCL
A follow-up analysis of patients enrolled in the multicenter ZUMA-1 trial for diffuse large B-cell lymphoma (DLBCL) showed axicabtagene ciloleucel can induce durable responses, yield a median overall survival of more than 2 years, and has a manageable long-term safety profile. Axicabtagene...
ASH 2018: ELIANA Trial: Tisagenlecleucel in Pediatric and Young Adult Patients With ALL
A single infusion of tisagenlecleucel (Kymriah) in pediatric and young adult patients with relapsed or treatment-resistant acute lymphocytic leukemia (ALL) continues to be highly effective in most patients, without the need for additional therapies. This latest analysis of the ELIANA trial results...
ASH 2018: Ibrutinib Alone or in Combination With Rituximab vs Bendamustine Plus Rituximab in Older Patients With CLL
A new study presented by Woyach et al at the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 6) showed that older patients with chronic lymphocytic leukemia (CLL) have a significantly lower rate of disease progression if treated with ibrutinib rather than...
ASH 2018: Updated Analysis of JULIET Trial: Tisagenlecleucel in Relapsed or Refractory DLBCL
In an update to the global JULIET clinical trial, the chimeric antigen receptor (CAR) T-cell therapy tisagenlecleucel (Kymriah) led to long-lasting remissions in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The most recent results from the trial were presented by...
2018 National Youth Tobacco Survey Shows Increase in E-Cigarette Use Among Youth
The U.S. Food and Drug Administration (FDA) and U.S. Centers for Disease Control and Prevention (CDC) recently released new findings from the National Youth Tobacco Survey (NYTS) showing that more than 3.6 million middle and high school students were current (past 30 day) e-cigarette users in...
FDA Approves Gilteritinib for Relapsed or Refractory FLT3-Mutated AML
Today, the U.S. Food and Drug Administration (FDA) approved gilteritinib (Xospata) for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test. The FDA also approved an expanded indication for a companion ...
First Rituximab Biosimilar for Non-Hodgkin Lymphoma Approved by FDA
Today, the U.S. Food and Drug Administration (FDA) approved rituximab-abbs (Truxima) as the first biosimilar to rituximab (Rituxan) for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin lymphoma to be used as a single agent or in combination with chemotherapy. Rituximab-abbs is ...
FDA Approves Venetoclax Combination for Adults With AML
On November 21, 2018, the U.S. Food and Drug Administration (FDA) granted accelerated approval to venetoclax (Venclexta) in combination with azacitidine or decitabine or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older or...
FDA Approves Larotrectinib for Solid Tumors With NTRK Gene Fusions
On November 26, 2018, the U.S. Food and Drug Administration (FDA) granted accelerated approval to larotrectinib (Vitrakvi) for adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, whose...
FDA Approves Pembrolizumab for Hepatocellular Carcinoma Previously Treated With a Kinase Inhibitor
ON NOVEMBER 9, 2018, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) for patients with hepatocellular carcinoma who have been previously treated with the kinase inhibitor sorafenib (Nexavar). KEYNOTE-224 APPROVAL WAS based on KEYNOTE-224, a...
Nivolumab for Third-Line Treatment of Metastatic Small Cell Lung Cancer
ON AUGUST 16, 2018, nivolumab (Opdivo) was granted accelerated approval for treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression after platinum-based chemotherapy and at least one other line of therapy.1,2 Supporting Efficacy Data APPROVAL WAS BASED on...
FDA Expands Approved Use of Brentuximab Vedotin in Some Types of PTCL
ON NOVEMBER 16, 2018, the U.S. Food and Drug Administration (FDA) expanded the approved use of brentuximab vedotin (Adcetris) injection in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma (PTCL)—adults with previously untreated systemic anaplastic...
Iobenguane I-131 for Advanced Pheochromocytoma or Paraganglioma
ON JULY 30, 2018, the radiotherapeutic agent iobenguane I-131 (Azedra) was approved for the treatment of adult and pediatric patients (aged ≥ 12 years) with iobenguane scan–positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer...
FDA Approves Elotuzumab Plus Pomalidomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma
ON NOVEMBER 6, 2018, following Priority Review, the U.S. Food and Drug Administration (FDA) approved elotuzumab (Empliciti) injection for intravenous use in combination with pomalidomide (Pomalyst) and dexamethasone for the treatment of adult patients with multiple myeloma who have received at...
FDA Approves Glasdegib for Patients With Newly Diagnosed AML Who Cannot Undergo Intensive Chemotherapy
Today, the U.S. Food and Drug Administration (FDA) approved glasdegib (Daurismo) tablets to be used in combination with low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults who are 75 years of age or older or with comorbidities that may preclude the use of ...
Cemiplimab-rwlc for Metastatic or Locally Advanced Cutaneous Squamous Cell Carcinoma
On September 28, 2018, cemiplimab-rwlc (Libtayo) was approved for the treatment of patients with metastatic cutaneous squamous cell carcinoma or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation.1 Supporting Efficacy Data Approval...
Duvelisib in Resistant Chronic Lymphocytic Leukemia: Expanding the Treatment Armamentarium
The phase III DUO trial, reported by Flinn et al and reviewed in this issue of The ASCO Post, has led to the U.S. Food and Drug Administration (FDA) approval of a novel B-cell receptor (BCR) kinase inhibitor, duvelisib (Copiktra), which targets phosphoinositide 3-kinase (PI3K)-δ/γ in patients...
Dacomitinib for Metastatic EGFR-Mutant NSCLC
On September 27, 2018, dacomitinib (Vizimpro) received approval for the first-line treatment of patients with metastatic non–small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations, as detected by a test approved by the...
FDA Approves Lorlatinib for Second- or Third-Line Treatment of ALK-Positive Metastatic NSCLC
On November 2, 2018, the U.S. Food and Drug Administration granted accelerated approval to lorlatinib (Lorbrena) for patients with anaplastic lymphoma kinase (ALK)-positive metastatic non–small cell lung cancer (NSCLC) whose disease has progressed on crizotinib (Xalkori) and at least one other ALK ...
Steven A. Rosenberg, MD, PhD, Works to Unmask Cancer’s Achilles Heel
Steven A. Rosenberg, MD, PhD, knew from the start of his medical career that if treatments for cancer were to become curative, research in new therapies would have to move away from the mainstay one-size-fits-all approach of systemic chemotherapy to an innovative, personalized strategy that...
FDA Expands Approved Use of Brentuximab Vedotin in Some Types of PTCL
Today, the U.S. Food and Drug Administration (FDA) expanded the approved use of brentuximab vedotin (Adcetris) injection in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma (PTCL)—adults with previously untreated systemic anaplastic large cell...
FDA Pipeline: What’s New in Biosimilars, Drug Reviews, Designations, and More
The U.S. Food and Drug Administration (FDA) recently issued the following new approvals and designations: Approval for Pegfilgrastim Biosimilar The FDA recently approved a pegfilgrastim biosimilar, pegfilgrastim-cbqv (Udenyca). The biosimilar has been approved to decrease the incidence...
FDA Approves Pembrolizumab for Hepatocellular Carcinoma Previously Treated With a Kinase Inhibitor
On November 9, 2018, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) for patients with hepatocellular carcinoma who have been previously treated with the kinase inhibitor sorafenib. KEYNOTE-224 Approval was based on KEYNOTE-224, a single-arm,...
Venetoclax for CLL or SLL With or Without 17p Deletion After Prior Therapy
On June 8, 2018, venetoclax (Venclexta) was granted regular approval for treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy.1,2 Supporting Efficacy Data APPROVAL WAS BASED on ...
Progression-Free Survival and Health-Related Quality of Life in Randomized Clinical Trials
A review and analysis of randomized clinical trials published by Kovic et al in JAMA Internal Medicine questioned whether interventions that prolong progression-free survival (PFS) in patients with cancer improve their health-related quality of life (HRQoL). The systematic review and quantitative...
FDA Approves Elotuzumab Plus Pomalidomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma
On November 6, the U.S. Food and Drug Administration (FDA) approved elotuzumab (Empliciti) injection for intravenous use in combination with pomalidomide (Pomalyst) and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies,...
Thomas J. Dougherty, PhD, Father of Photodynamic Therapy, Dies at Age 85
Thomas J. Dougherty, PhD, the developer of modern photodynamic therapy and Chief Emeritus of Roswell Park’s Photodynamic Therapy Center, died October 2, 2018, in Buffalo, New York. “He was undoubtedly the major influence in bringing [photodynamic therapy] into the realm of cancer therapy,” said...
Without Genomic Sequencing, I Would Not Be Alive Today
The extreme fatigue I experienced during the winter of my fourth year in medical school, in 2003, was easily attributable to the rigors of my medical training and the lack of sleep that comes from trying to keep up with an intensely busy schedule. I was looking forward to resting and recuperating...
FDA Releases Draft Guidance for Clinical Trial Design
The U.S. Food and Drug Administration (FDA) announced the availability of the Draft Guidance Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Cancer Drugs and Biologics. Master protocol trial designs are complex due to the concurrent evaluation of multiple...
Nilotinib for Pediatric Patients With Philadelphia Chromosome–Positive CML in Chronic Phase
Earlier in 2018, nilotinib (Tasigna) was approved for the treatment of pediatric patients aged ≥ 1 year with newly diagnosed Philadelphia chromosome–positive chronic myeloid leukemia in chronic phase (CML-CP) or Philadelphia chromosome–positive CML-CP resistant or intolerant to prior tyrosine...
FDA Approves Levoleucovorin for Treatment in Osteosarcoma, Colorectal Cancer
The U.S. Food and Drug Administration (FDA) recently approved levoleucovorin (Khapzory) injection, a folate analog, for three indications: rescue after high-dose methotrexate therapy in patients with osteosarcoma; diminishing the toxicity associated with overdosing on folic acid antagonists or...
