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Showing 1251 - 1300Luspatercept-aamt for Anemia in Adults With Myelodysplastic Syndromes
On April 3, 2020, luspatercept-aamt was approved in the treatment of anemia failing to respond to an erythropoiesis-stimulating agent and requiring 2 or more red blood cell (RBC) units over 8 weeks.1,2 The treatment is geared toward adult patients with very low– to intermediate-risk myelodysplastic ...
Selumetinib for Pediatric Neurofibromatosis Type 1 With Symptomatic, Inoperable Plexiform Neurofibromas
On April 10, 2020, the oral MEK inhibitor selumetinib was approved for the treatment of patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas.1,2 Selumetinib is the first therapy approved for children who have this disease....
Pemigatinib for Previously Treated Cholangiocarcinoma With FGFR2 Rearrangement or Fusion
On April 17, 2020, pemigatinib was granted accelerated approval for the treatment of adults with previously treated unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by a U.S. Food and Drug...
Expert Point of View: Thomas J. Herzog, MD
Thomas J. Herzog, MD, Deputy Director, University of Cincinnati Cancer Center, who presented a distillation of the PRIMA trial data along with updated results of the phase III PAOLA-1 trial of olaparib plus bevacizumab maintenance, called the data “practice-changing.” “We’ve suspected for a while...
Niraparib as First-Line Maintenance Therapy for Advanced Ovarian Cancers
Making sense of maintenance therapy in advanced ovarian cancer has been a tall order since the publication of impressive data for not one but three PARP inhibitors at the European Society for Medical Oncology (ESMO) 2019 Congress.1 The picture became a little clearer on April 29, 2020, however,...
FDA Approves Olaparib for HRR Gene–Mutated Metastatic Castration-Resistant Prostate Cancer
On May 19, the U.S. Food and Drug Administration (FDA) approved olaparib (Lynparza) for adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene–mutated metastatic castration-resistant prostate cancer who have had disease progression...
FDA Approves Atezolizumab for the First-Line Treatment of Patients With Metastatic NSCLC and High PD-L1 Expression
On May 18, the U.S. Food and Drug Administration (FDA) approved atezolizumab (Tecentriq) for the first-line treatment of adult patients with metastatic non–small cell lung cancer (NSCLC) whose tumors have high programmed cell death ligand 1 (PD-L1) expression (PD-L1 stained ≥ 50% of tumor cells or...
FDA Pipeline: Two Breakthrough Therapy Designations for Fam-Trastuzumab Deruxtecan-nxki, and More
Over the past few weeks, the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designations for an antibody-drug conjugate in the treatment of gastric and lung cancers. The Agency has also issued Orphan Drug designations for agents being investigated in chronic myeloid...
FDA Approves Rucaparib in BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer
On May 15, the U.S. Food and Drug Administration (FDA) granted accelerated approval to rucaparib (Rubraca) for patients with deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer who have been treated with androgen receptor–directed therapy...
FDA Approves Ripretinib for Previously Treated Patients With Advanced Gastrointestinal Stromal Tumor
On May 15, the U.S. Food and Drug Administration (FDA) approved ripretinib (Qinlock) for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with three or more kinase inhibitors, including imatinib. INVICTUS Trial Efficacy was...
FDA Approves Nivolumab/Ipilimumab for First-Line Treatment of Patients With Metastatic NSCLC and PD-L1 Tumor Expression ≥ 1%
On May 15, 2020, the U.S. Food and Drug Administration (FDA) approved the combination of nivolumab (Opdivo) plus ipilimumab (Yervoy) as first-line treatment for patients with metastatic non–small cell lung cancer (NSCLC) whose tumors express programmed cell death ligand 1 (PD-L1) at ≥ 1%, as...
FDA Approves Pomalidomide for Kaposi Sarcoma
On May 14, 2020, the U.S. Food and Drug Administration (FDA) expanded the indication of pomalidomide (Pomalyst) to include treating adult patients with acquired immunodeficiency syndrome (AIDS)-related Kaposi sarcoma after failure of highly active antiretroviral therapy and those with Kaposi...
Cancer vs COVID-19: Clinical Trial Research During the Pandemic
The COVID-19 pandemic transformed cancer care, seemingly overnight, as practices scrambled to ensure a safe environment for caregivers and patients. Although regulatory burdens have been relaxed to allow patients to continue on trial treatment and telemedicine has expanded its competency and reach, ...
FDA Approves Selpercatinib for Lung and Thyroid Cancers With RET Mutations or Fusions
On May 8, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to selpercatinib (Retevmo) for the following indications: Adult patients with metastatic RET fusion–positive non–small cell lung cancer (NSCLC) Adult and pediatric patients ≥ 12 years of age with advanced or...
Durvalumab Plus Chemotherapy for Extensive-Stage Small Cell Lung Cancer
On March 27, 2020, durvalumab (Imfinzi) was approved for use in combination with etoposide and either carboplatin or cisplatin as first-line treatment of patients with extensive-stage small cell lung cancer.1,2 Supporting Efficacy Data Approval was based on the findings of the open-label phase III ...
Encorafenib Combined With Cetuximab in Previously Treated BRAF V600E–Mutant Metastatic Colorectal Cancer
On April 8, 2020, encorafenib was approved for use in combination with cetuximab for the treatment of previously treated adult patients with metastatic colorectal cancer with a BRAF V600E mutation detected by a U.S. Food and Drug Administration (FDA)-approved test.1,2 Encorafenib is not indicated...
Understanding Patient-Reported Outcomes in Cancer Trials: A Beginner’s Guide
Patient-reported outcomes are measures used in clinical trials to capture aspects of a patient’s health condition, reported directly by the patient, without introduction of bias from third parties. They are distinct from the physical toxicities reported by clinicians1 and are collected using a...
Bispecific Antibodies Poised to Impact Treatment of Lymphoma and Other Blood Cancers
Studies of second-generation bispecific antibodies were among the highlights of the 2019 American Society of Hematology (ASH) Annual Meeting & Exposition. The bispecific T-cell engager blinatumomab was the first such agent to be approved by the U.S. Food and Drug Administration (FDA) in...
Early Signs of Activity With Immunotherapies in Low-Incidence Cancers
Immunotherapy is showing promise for patients with rare cancers, offering new treatment opportunities and clinical trials to those with previously limited options. At the 2020 ASCO-SITC Clinical Immuno-Oncology Symposium, presenters discussed the use of immunotherapy in three low-incidence cancers: ...
New Guideline on Systemic Therapy for Melanoma Tackles Rapid Developments in Treatment Options
Systemic treatment of melanoma has changed rapidly since the introduction of ipilimumab in 2011. Newer therapies approved for melanoma since that time include immunotherapy, targeted therapy for mutation-bearing tumors, and injectional therapy for cutaneous or palpable lesions. ASCO has released...
PARP Inhibitors in Maintenance Treatment for Advanced Ovarian Cancer
Based on multiple phase III prospective trials, there is evidence that both PARP inhibitors and antiangiogenic therapies such as bevacizumab provide benefit when utilized in a maintenance strategy in the first-line treatment of advanced epithelial ovarian cancer (GOG 218, ICON7, SOLO-1, PRIMA,...
FDA Approves Olaparib Plus Bevacizumab as Maintenance Treatment for Ovarian, Fallopian Tube, or Primary Peritoneal Cancers
On May 8, 2020, the U.S. Food and Drug Administration (FDA) expanded the indication of olaparib (Lynparza) to include its combination with bevacizumab for first-line maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in...
FDA Approves Capmatinib for Patients With Metastatic NSCLC With Confirmed MET Exon 14 Skipping
On May 6, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to capmatinib (Tabrecta) for adult patients with metastatic non–small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by...
Issues With Travel Faced by Patients Undergoing Lu-177 Dotatate Radiation Therapy
A team of researchers and patient advocates have addressed the challenges related to traveling after receiving radiation therapy involving Lu-177 dotatate in a study published by Kendi et al in The Journal of Nuclear Medicine. Due to the residual radiation activity of Lu-177 dotatate, some patients ...
FDA Issues Emergency Use Authorization for Remdesivir for Treatment of Severe COVID-19
The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the investigational antiviral drug remdesivir for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease. Severe disease is defined as low...
FDA Approves Daratumumab and Hyaluronidase-fihj in Multiple Myeloma
On May 1, the U.S. Food and Drug Administration (FDA) approved daratumumab and hyaluronidase-fihj (Darzalex Faspro) for adult patients with newly diagnosed, relapsed, or refractory multiple myeloma. This new product allows for subcutaneous dosing of daratumumab. Daratumumab and hyaluronidase-fihj...
FDA Pipeline: Priority Review in AML, Fast Track Designations for Pancreatic Cancer and Neuroendocrine Tumors
Over the past 2 weeks, the U.S. Food and Drug Administration (FDA) granted Priority Review to a treatment for acute myeloid leukemia (AML); Fast Track designations for agents in pancreatic cancer and pancreatic/nonpancreatic neuroendocrine tumors; approvals for companion diagnostic tests;...
FDA Approves Niraparib as Maintenance Therapy for Advanced Ovarian Cancer
On April 29, the U.S. Food and Drug Administration (FDA) approved niraparib (Zejula) for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy....
FDA Approves New Pembrolizumab Dosing Regimen
On April 28, the U.S. Food and Drug Administration (FDA) granted accelerated approval to a new dosing regimen for pembrolizumab (Keytruda)—400 mg every 6 weeks—across all currently approved adult indications, in addition to the current 200 mg every 3 weeks dosing regimen. The approval was based on...
Recent FDA Oncology/Hematology Approvals
The U.S. Food and Drug Administration (FDA) had a very busy 10 or so days, so this week, we’ll go over five recent oncology and hematology approvals the Agency issued, in bladder cancer, breast cancer, bile duct cancer, and leukemia.
Isatuximab-irfc for Previously Treated Multiple Myeloma
On March 2, 2020, the CD-38-directed cytolytic antibody isatuximab-irfc (Sarclisa) was approved for use in combination with pomalidomide and dexamethasone for adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.1,2...
FDA Accelerates Development of Novel Therapies for COVID-19
The U.S. Food and Drug Administration (FDA) has implemented a program to expedite the development of potentially safe and effective life-saving treatments. The program, known as the Coronavirus Treatment Acceleration Program (CTAP), is using every tool at the agency’s disposal to bring new...
Selected ASH Abstracts on Novel Treatments for Non-Hodgkin Lymphomas
To complement The ASCO Post’s continued comprehensive coverage of the 2019 American Society of Hematology (ASH) Annual Meeting & Exposition, here are several abstracts selected from the meeting proceedings focusing on novel therapies for patients with non-Hodgkin lymphomas (NHLs). For full...
ASCENT Study Halted: Efficacy Shown Across Multiple Study Endpoints in Triple-Negative Breast Cancer
The phase III confirmatory ASCENT study of the antibody drug-conjugate sacituzumab govitecan will be stopped based on efficacy across multiple study endpoints following unanimous recommendation from the independent data safety monitoring committee, according to a news release issued earlier this...
More Antibody-Drug Conjugates on the Horizon for Breast Cancer
Novel antibody-drug conjugates that target actionable cell-surface markers in metastatic breast cancer will soon expand the utility of the class that already includes ado-trastuzumab emtansine (T-DM1), according to two speakers at the 2020 Miami Breast Cancer Conference. These new agents were...
FDA’s Draft Guidance Will Improve Evidence Base for Older Adults With Cancer
ASCO commends the U.S. Food and Drug Administration (FDA) for releasing draft guidance that encourages inclusion of older adults in clinical trials of drugs for the treatment of cancer. The guidance emphasizes the importance of including adults aged 75 or older in clinical trials to better enable...
AACR Provides Scientific Expertise to Assist FDA’s Public Health Initiative
The American Association for Cancer Research (AACR) is working with the U.S. Food and Drug Administration (FDA) to advance the FDA’s public health initiative called Project Renewal. Launched in October 2018 by the FDA’s Oncology Center for Excellence (OCE), Project Renewal has an ambitious goal to...
Nivolumab/Ipilimumab in Patients With Sorafenib-Pretreated Hepatocellular Carcinoma
On March 10, 2020, the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) was granted accelerated approval for treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib.1-3 Supporting Efficacy Data The approval was based on findings in a cohort...
Unnecessary Barrier to Blood Donation for British Nationals?
I read with great interest Jo Cavallo’s article “Maintaining Blood Donations During the COVID-19 Pandemic”. My wife and I have been British residents in the United States for over 6 years and are frustrated that we cannot donate blood, especially during this raging global COVID-19 pandemic, when...
FDA Approves Sacituzumab Govitecan-hziy for Patients With Previously Treated Metastatic Triple-Negative Breast Cancer
On April 22, the U.S. Food and Drug Administration (FDA) approved sacituzumab govitecan-hziy (Trodelvy) for the treatment of adult patients with metastatic triple-negative breast cancer who have received at least two prior therapies for metastatic disease. Sacituzumab govitecan-hziy is the first...
FDA Approves Ibrutinib/Rituximab for CLL/SLL
On April 21, the U.S. Food and Drug Administration (FDA) expanded the indication of ibrutinib (Imbruvica) to include its combination with rituximab for the initial treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This review was conducted...
FDA Authorizes First COVID-19 Test for Patient At-Home Sample Collection
The U.S. Food and Drug Administration (FDA) authorized the first diagnostic test with a home collection option for COVID-19. Specifically, the FDA re-issued the emergency use authorization (EUA) for the Laboratory Corporation of America (LabCorp) COVID-19 RT-PCR Test to permit testing of samples...
FDA Approves Pemigatinib for Patients With Cholangiocarcinoma and an FGFR2 Rearrangement or Fusion
On April 17, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pemigatinib (Pemazyre) for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or...
FDA Approves Tucatinib in Combination With Trastuzumab/Capecitabine for Advanced Unresectable or Metastatic HER2-Positive Breast Cancer
On April 17, the U.S. Food and Drug Administration (FDA) granted approval to tucatinib (Tukysa) in combination with trastuzumab/capecitabine for adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or...
FDA Encourages Plasma Donation From Patients Who Have Recovered From COVID-19, Collaborates to Produce Supplies for Testing
This week, the U.S. Food and Drug Administration (FDA) issued a statement encouraging patients who have fully recovered from COVID-19 for at least 2 weeks to donate plasma, in order to ramp up supply of convalescent plasma for treatment of infected individuals. The agency also announced that spun...
FDA Approves Mitomycin Gel for Low-Grade Upper Tract Urothelial Cancer
On April 15, the U.S. Food and Drug Administration (FDA) approved mitomycin (Jelmyto) for adult patients with low-grade upper tract urothelial cancer. OLYMPUS Trial Efficacy determination was based on OLYMPUS, an ongoing, single-arm, multicenter trial enrolling 71 patients with treatment-naive or...
Joint Publication Focuses on Clinical Practice Guidelines on Opioid Use for Pain Management
A recently published article by Schatz et al offers new clarity around the use of prescription opioids in pain management for people with a diagnosis or history of cancer and chronic pain. The joint publication, which appeared in both JNCCN—Journal of the National Comprehensive Cancer Network and...
FDA Pipeline: Priority Reviews for Immunotherapy Based on Biomarker Status, Combination First-Line Therapy in Lung Cancer
Over the past week, the U.S. Food and Drug Administration (FDA) granted Priority Review to an immunotherapeutic agent for solid tumors with a high tumor mutational burden and to a combination treatment for the first-line treatment of metastatic or recurrent non–small cell lung cancer. The agency...
FDA Approves Selumetinib for Pediatric Patients With NF1 and Symptomatic Inoperable Plexiform Neurofibromas
On April 10, the U.S. Food and Drug Administration (FDA) approved selumetinib (Koselugo) for pediatric patients aged 2 years and older with neurofibromatosis type 1 (NF1) who have symptomatic inoperable plexiform neurofibromas. Selumetinib, a kinase inhibitor, is the first therapy approved for...
Updates From Selected Clinical Trials in Breast Cancer
Each year, The ASCO Post asks Jame Abraham, MD, FACP, Chairman of the Department of Hematology and Medical Oncology at Taussig Cancer Institute and Professor of Medicine at the Cleveland Clinic Lerner College of Medicine, to offer his picks for the most important research presented at 2019 San...
