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Showing 1801 - 1850FDA Authorizes First Next-Generation Sequencing–Based Test to Detect Minimal Residual Disease in B-Cell ALL or Multiple Myeloma
The U.S. Food and Drug Administration (FDA) recently permitted marketing of the ClonoSEQ assay, a next-generation sequencing–based test for minimal residual disease in patients with B-cell acute lymphoblastic leukemia (ALL) or multiple myeloma. “At the FDA, we’re continuing to...
Mogamulizumab-kpkc for Mycosis Fungoides and Sézary Syndrome
On August 8, 2018, the CC chemokine receptor type 4 (CCR4)-directed monoclonal antibody mogamulizumab-kpkc (Poteligeo) was approved for adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy.1,2 Supporting Efficacy Data The current...
Targeting CCR4 in Cutaneous T-Cell Lymphoma: The MAVORIC Trial
The C-C chemokine receptor 4 (CCR4) is predominantly expressed in type 2 helper T (Th2) cells and regulatory T (Treg) cells.1 Under physiologic conditions and in response to its ligands, CCL17 (TARC) and CCL22 (MDC), CCR4 promotes T-cell migration to the skin.2 Of note, CCR4 is highly expressed in...
Mogamulizumab Improves Progression-Free Survival vs Vorinostat in Cutaneous T-Cell Lymphoma
As reported by Youn H. Kim, MD, of Stanford Cancer Institute, Stanford University School of Medicine, and colleagues in The Lancet Oncology, the phase III MAVORIC trial showed that the anti-C-C chemokine receptor 4 (CCR4) monoclonal antibody mogamulizumab (Poteligeo) significantly improved...
Osimertinib in First-Line Treatment of EGFR-Mutant Metastatic NSCLC
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. In April 2018, osimertinib (Tagrisso) was approved for...
AACR Releases Annual Cancer Progress Report
The American Association for Cancer Research (AACR) has released its annual Cancer Progress Report,1 highlighting how federally funded research discoveries are fueling the development of new and even more effective ways to prevent, detect, diagnose, and treat cancer. Key advances outlined in the...
Neuroendocrine Tumors: New Data, New Options
Because neuroendocrine tumors are not one disease but a continuum of diseases, ranging from well-differentiated tumors to poorly differentiated and small cell tumors, treatment approaches can vary greatly. At the 2018 Debates and Didactics in Hematology and Oncology conference, held on Sea Island,...
FDA Approves Once-Weekly Carfilzomib in Combination With Dexamethasone for Relapsed or Refractory Multiple Myeloma
Today, the U.S. Food and Drug Administration (FDA) approved a supplemental new drug application (sNDA) to expand the prescribing information for carfilzomib (Kyprolis) to include a once-weekly dosing option in combination with dexamethasone (once-weekly Kd70) for patients with relapsed or...
FDA Approves Cemiplimab-rwlc for Metastatic Cutaneous Squamous Cell Carcinoma
On September 28, the U.S. Food and Drug Administration (FDA) approved cemiplimab-rwlc (Libtayo) injection for intravenous use for the treatment of patients with metastatic cutaneous squamous cell carcinoma (SCC) or locally advanced cutaneous SCC who are not candidates for curative surgery or...
FDA Approves Dacomitinib for Metastatic Non–Small Cell Lung Cancer
On September 27, 2018, the U.S. Food and Drug Administration (FDA) approved dacomitinib tablets (Vizimpro) 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...
FDA Approves Duvelisib for Adult Patients With Relapsed or Refractory CLL, SLL, and Follicular Lymphoma
On September 24, 2018, the U.S. Food and Drug Administration (FDA) granted regular approval to duvelisib (Copiktra) for adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies. In addition, duvelisib...
FDA Approves Moxetumomab Pasudotox-tdfk for the Treatment of Hairy Cell Leukemia
ON SEPTEMBER 13, 2018, the U.S. Food and Drug Administration (FDA) approved moxetumomab pasudotox-tdfk (Lumoxiti) injection for intravenous use for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who have received at least two prior systemic therapies,...
Pertuzumab in Adjuvant Treatment of HER2-Positive Breast Cancer
AT THE END OF 2017, pertuzumab (Perjeta) was granted regular approval 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.1,2 Supporting Efficacy Data APPROVAL WAS BASED on...
Abiraterone Acetate Plus Prednisone in High-Risk Metastatic Castration-Sensitive Prostate Cancer
IN EARLY 2018, abiraterone acetate tablets (Yonsa, Zytiga) in combination with prednisone was approved for the treatment of metastatic high-risk castration-sensitive prostate cancer.1,2 Supporting Efficacy Data APPROVAL WAS BASED on findings from the phase III LATITUDE trial, in which 1,199...
FDA Grants Rare Pediatric Disease Designation to CLR 131 in Treatment of Osteosarcoma
The U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease designation to CLR 131 for the treatment of osteosarcoma. CLR 131 has received Rare Pediatric Disease designation in four pediatric cancers: neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma, and now...
FDA Accepts sBLA for Pembrolizumab Monotherapy in First-Line Treatment of Locally Advanced or Metastatic PD-L1–Expressing NSCLC
The U.S. Food and Drug Administration (FDA) granted Priority Review to a new supplemental biologics license application (sBLA) seeking approval for pembrolizumab (Keytruda) as monotherapy for first-line treatment of locally advanced or metastatic nonsquamous or squamous non–small cell lung...
ASCO and Friends of Cancer Research Submit Recommendations to FDA Aimed at Reducing Barriers to Clinical Trial Participation
On August 8, ASCO and Friends of Cancer Research (Friends) submitted recommended language to the U.S. Food and Drug Administration (FDA) for five guidance documents on ways to broaden eligibility criteria for cancer clinical trials. The recommendations are part of an ASCO and Friends collaboration...
Are E-Cigarettes a Dangerous Alternative to Traditional Cigarettes?
Several studies published earlier this year present preliminary but compelling evidence that electronic cigarettes, also known as e-cigarettes, which deliver nicotine through aerosols without burning tobacco, may pose serious health consequences to users, including cardiovascular disease and...
CAR T-Cell Therapy for CLL
A pair of new studies from researchers at the Abramson Cancer Center of the University of Pennsylvania are shedding light on why patients with advanced chronic lymphocytic leukemia (CLL) respond or do not respond to chimeric antigen receptor (CAR) T-cell therapy. Although CAR T-cell therapy is...
Pembrolizumab for Advanced Cervical Cancer Progressing During or After Chemotherapy
In June 2018, pembrolizumab (Keytruda) was approved for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express programmed cell death ligand 1 (PD-L1; combined positive score [CPS] ≥ 1), as determined by a U.S....
Pembrolizumab in Relapsed or Refractory Primary Mediastinal 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 June 13, 2018, pembrolizumab (Keytruda) was granted...
Update on Clinical Trials of Novel Therapies
Long-term follow-up data on axicabtagene ciloleucel (Yescarta) in lymphoma, potential partners for nivolumab (Opdivo) in solid tumors, and a targeted agent for RET-altered cancers were featured during the developmental therapeutics program at the 2018 ASCO Annual Meeting. At the Best of ASCO...
FDA Takes New Steps to Address Youth E-Cigarette Use
The U.S. Food and Drug Administration (FDA) has announced a series of critical and historic enforcement actions related to the sale and marketing of e-cigarettes to children. In the largest coordinated enforcement effort in the its history, the agency issued more than 1,300 warning...
New Recommendations for Cabozantinib Tablets in Updated NCCN Clinical Practice Guidelines
Recently, the National Comprehensive Cancer Network® (NCCN®) updated its Clinical Practice Guidelines to include new recommendations for cabozantinib (Cabometyx) tablets. With the updates, cabozantinib is recommended by the NCCN for the treatment of advanced renal cell carcinoma regardless...
FDA Approves Moxetumomab Pasudotox-tdfk for the Treatment of Hairy Cell Leukemia
The U.S. Food and Drug Administration (FDA) today approved moxetumomab pasudotox-tdfk (Lumoxiti) injection for intravenous use for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who have received at least two prior systemic therapies, including treatment with...
AACR Releases Annual Cancer Progress Report
The American Association for Cancer Research (AACR) has released its annual Cancer Progress Report highlighting how federally funded research discoveries are fueling the development of new and even more effective ways to prevent, detect, diagnose, and treat cancer. Key advances outlined...
Recent Drug Approvals and Revisions in Prescribing Information
THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) issued the following approvals and prescribing information revisions in August 2018. Lenvatinib Approved for Unresectable Hepatocellular Carcinoma THE FDA approved lenvatinib (Lenvima) for the first-line treatment of patients with unresectable...
FDA Approves First Nonchemotherapy Combination Regimen for Patients With Waldenström’s Macroglobulinemia
ON AUGUST 27, 2018, the U.S. Food and Drug Administration (FDA) approved the combination of ibrutinib (Imbruvica) and rituximab (Rituxan) for patients with Waldenström’s macroglobulinemia. The recent approval expands the label for ibrutinib in Waldenström’s macroglobulinemia beyond its current...
FDA Grants Breakthrough Therapy Designation to LOXO-292 for Treatment of Lung and Thyroid Cancers
The U.S. Food and Drug Administration (FDA) recently granted Breakthrough Therapy designation to LOXO-292, a selective RET inhibitor, for: the treatment of patients with metastatic RET fusion–positive non–small cell lung cancer (NSCLC) who require systemic therapy and have had...
Treating Nonmetastatic Castration-Resistant Prostate Cancer: Implications of the PROSPER Trial
A MAN in his early 70s sits in our office. His general health is good, and he is feeling well. Yet he is deeply worried. Four years ago, when his prostate-specific antigen (PSA) level rapidly increased after radical prostatectomy and subsequent radiation therapy, he was started on...
FDA Grants Priority Review to sBLA for Pembrolizumab in Merkel Cell Carcinoma
The U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a new supplemental biologics license application (sBLA) seeking accelerated approval for pembrolizumab (Keytruda) for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic...
Ribociclib in Hormone Receptor–Positive, HER2-Negative Advanced Breast Cancer
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 July 18, 2018, the indication for ribociclib (Kisqali) ...
Ipilimumab in Combination With Nivolumab for MSI-H or dMMR Metastatic Colorectal Cancer
On July 10, 2018, ipilimumab (Yervoy) was granted accelerated approval for use in combination with nivolumab (Opdivo) for the treatment of patients at least 12 years of age with microsatellite instability–high (MSI-H) or mismatch repair–deficient (dMMR) metastatic colorectal cancer progressing...
Improving the Lives of Patients With Cancer Is Richard L. Schilsky’s Lifelong Mission
In 2009, as Richard L. Schilsky, MD, FACP, FSCT, FASCO, was preparing his Presidential Address for that year’s ASCO Annual Meeting, he came across his 6th grade essay titled “My Ambition,” which foretold with eerie specificity the career path he would follow over the next 6 decades. In the paper,...
FDA Accepts sBLA for Dasatinib in Pediatric Patients With Newly Diagnosed Ph-Positive ALL
The U.S. Food and Drug Administration (FDA) recently accepted a supplemental biologics license application (sBLA) for dasatinib in combination with chemotherapy for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome (Ph)-positive acute lymphoblastic leukemia...
Statement From FDA Commissioner on Support for Exempting Coffee From California’s Cancer Warning Law
Scott Gottlieb, MD, Commissioner of the U.S. Food and Drug Administration, recently issued the following statement: “Ensuring that food is safe and truthfully labeled is one of our fundamental responsibilities at the FDA. Consumers deserve accurate information about the food they eat and how ...
FDA Approves cobas EGFR Mutation Test v2 as Companion Diagnostic With Gefitinib in First-Line Treatment of NSCLC
The U.S. Food and Drug Administration (FDA) recently approved the cobas EGFR Mutation Test v2 as a companion diagnostic test with gefitinib (Iressa) for the first-line treatment of patients with non–small cell lung cancer (NSCLC). A companion diagnostic test provides information that is...
FDA Accepts sBLA for Elotuzumab Plus Pomalidomide and Low-Dose Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
The U.S. Food and Drug Administration (FDA) recently accepted a supplemental biologics license application (sBLA) for elotuzumab (Empliciti) in combination with pomalidomide (Pomalyst) and low-dose dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who...
CAR T-Cell Therapy in Europe: Differing Decisions on Approval of Two Agents
The European Commission (EC) recently approved the chimeric antigen receptor (CAR) T-cell therapy tisagenlecleucel (Kymriah) in the European Union (EU) for the treatment of pediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukemia (ALL) that is...
FDA Approves Ibrutinib Plus Rituximab for Waldenström’s Macroglobulinemia
The U.S. Food and Drug Administration (FDA) has approved ibrutinib (Imbruvica) plus rituximab (Rituxan) for the treatment of adult patients with Waldenström's macroglobulinemia (WM). With this approval, the ibrutinib prescribing information now includes combination use with rituximab,...
FDA Grants Fast Track Designation to AVB-S6-500 for Platinum-Resistant Ovarian Cancer
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to AVB-S6-500 as a potential treatment for platinum-resistant recurrent ovarian cancer. About AVB-S6-500 AVB-S6-500 is a novel high-affinity, soluble Fc-fusion protein designed to block the activation of the GAS6-AXL...
Blinatumomab in Adult and Pediatric Patients With B-Cell Precursor Acute Lymphoblastic Leukemia
EARLY IN 2018, blinatumomab (Blincyto) was granted accelerated approval for the treatment of adult and pediatric patients with B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease ≥ 0.1%.1,2 Supporting Efficacy Data APPROVAL WAS...
Ivosidenib for Relapsed or Refractory Acute Myeloid Leukemia
ON JULY 20, 2018, the U.S. Food and Drug Administration (FDA) approved ivosidenib (Tibsovo) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation, as detected by an FDA-approved test.1,2 The FDA...
FDA Grants Orphan Drug Designation to ASLAN003 in Acute Myeloid Leukemia
The U.S. Food and Drug Administration (FDA) has granted ASLAN003 Orphan Drug designation as a treatment for acute myeloid leukemia (AML). ASLAN003 is an orally active, potent inhibitor of human dihydroorotate dehydrogenase (DHODH) that has the potential to be a first-in-class drug in AML. The FDA...
FDA Grants Orphan Drug Designation to CPI-613 for the Treatment of Peripheral T-Cell Lymphoma
The U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to CPI-613 for the treatment of peripheral T-cell lymphoma. CPI-613 is a novel lipoic acid analog with an anticancer activity that inhibits multiple enzyme targets within the tricarboxylic acid cycle. This drug is...
FDA Approves Pembrolizumab in Combination With Chemotherapy for First-Line Treatment of Metastatic Nonsquamous NSCLC
Today, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) in combination with pemetrexed (Alimta) and platinum as first-line treatment of patients with metastatic, nonsquamous non–small cell lung cancer with no EGFR or ALK genomic tumor aberrations. Pembrolizumab...
FDA Updates Prescribing Information for Pembrolizumab and Atezolizumab in Urothelial Carcinoma
On August 16, 2018, the U.S. Food and Drug Administration (FDA) updated the prescribing information for pembrolizumab (Keytruda) and atezolizumab (Tecentriq) to require the use of an FDA-approved companion diagnostic test to determine programmed cell death ligand 1 (PD-L1) levels in tumor tissue...
FDA Approves Nivolumab for Certain Patients With Previously Treated Small Cell Lung Cancer
Today, nivolumab (Opdivo) received approval from the U.S. Food and Drug Administration (FDA) for patients with metastatic small cell lung cancer (SCLC) whose cancer has progressed after platinum-based chemotherapy and at least one other line of therapy. Approval for this indication has been...
FDA Accepts Biologics License Application, Grants Priority Review for Tagraxofusp in Rare Hematologic Malignancy
The U.S. Food and Drug Administration (FDA) has accepted for filing a biologics license application (BLA) for tagraxofusp (Elzonris, formerly SL-401) for the treatment of patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare hematologic malignancy. The FDA also granted Priority ...
Enzalutamide in Nonmetastatic Castration-Resistant Prostate Cancer
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 July 13, 2018, enzalutamide (Xtandi) was approved for...
