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Showing 1251 - 1300FDA 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...
FDA Approves Encorafenib/Cetuximab for BRAF V600E–Mutated Metastatic Colorectal Cancer
On April 8, the U.S. Food and Drug Administration (FDA) approved encorafenib (Braftovi) in combination with cetuximab (Erbitux) for the treatment of pretreated adult patients with metastatic colorectal cancer with a BRAF V600E mutation detected by an FDA-approved test. BEACON CRC Efficacy was...
Clinical Trials to Evaluate Activity of Biologics, Other Agents Against COVID-19
In an effort to expedite research for agents with potential activity against symptoms associated with the novel coronavirus (COVID-19), the U.S. Food and Drug Administration (FDA) is evaluating and/or has approved a number of randomized clinical trials seeking to determine whether a drug has...
FDA Approves Luspatercept-aamt for Second-Line Treatment of Anemia in Adult Patients With Myelodysplastic Syndromes
On April 3, the U.S. Food and Drug Administration (FDA) approved luspatercept-aamt (Reblozyl) for the treatment of anemia that fails to respond to an erythropoiesis-stimulating agent and requires two or more red blood cell units over 8 weeks in adult patients with very low- to intermediate-risk...
FDA Pipeline: Approval of New Dosing for Biosimilar, Plus Two Fast Track Designations
The U.S. Food and Drug Administration (FDA) recently approved a new dose for a biosimilar referencing trastuzumab and granted Fast Track designations to agents for patients with urothelial cancer and follicular lymphoma. Approval of Multidose Vial of Trastuzumab Biosimilar The FDA approved a...
Maintaining Blood Donations During the COVID-19 Pandemic
A major casualty of the coronavirus disease 2019 (COVID-19) pandemic is the dramatic decrease in the number of blood donations across the United States. As more people are urged to shelter-in-place and avoid social contact, the number of cancellations in blood drives has been dramatic. According to ...
FDA Approves Durvalumab as Part of a First-Line Combination Regimen for Extensive-Stage SCLC
On March 27, the U.S. Food and Drug Administration (FDA) approved durvalumab (Imfinzi) in combination with etoposide and either carboplatin or cisplatin as first-line treatment of patients with extensive-stage small cell lung cancer (SCLC). CASPIAN Trial Efficacy of this combination in patients...
Neratinib Combined With Capecitabine in Previously Treated Advanced HER2-Positive Breast Cancer
On February 25, 2020, neratinib (Nerlynx) was approved for use in combination with capecitabine for treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti–HER2-based regimens in the metastatic setting.1,2 Supporting Efficacy ...
A Message From the FDA OCE for Patients With Cancer and Health-Care Providers on COVID-19
On March 23, the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) issued the following statement: The FDA OCE recognizes that patients with cancer constitute a vulnerable population at risk of contracting the coronavirus disease (COVID-19). While everyone’s daily lives...
TAPUR Basket Study: Biomarker-Driven Treatment Strategies Yield Benefits in Colorectal Cancer
Positive findings on the potential benefit of molecularly targeted drugs in patients with advanced colorectal cancer were presented at the 2020 Gastrointestinal Cancers Symposium, validating the purpose of ASCO’s Targeted Agent and Profiling Utilization Registry (TAPUR) study.1-3 TAPUR, the first...
Coronavirus, Patients With Cancer, and the Preparedness of the Institutions That Care for Them
We're covering the topic on everyone’s minds—coronavirus. We’ll start with the state of the epidemic as it relates to patients with cancer and the preparedness of the institutions that care for them. Next, we’ll look at a study from China that examined the impact of COVID-19 on patients with...
Continuous Coverage of COVID-19
The staff of The ASCO Post recognizes the steady flow of news on the novel coronavirus, or COVID-19. Here, we've compiled a list of links to articles and resources on the COVID-19 pandemic. If you have a report you'd like to share, please e-mail it to us at editor@ascopost.com. Direct From ASCO:...
Mitigating the Spread of COVID-19 and Its Impact on Cancer
On March 11, the World Health Organization (WHO) took the step it had been avoiding for weeks and declared that the spread of the coronavirus disease 2019 (COVID-19), and the virus that causes it, now identified as SARS-CoV-2, had reached global pandemic levels, the first pandemic sparked by a...
FDA Pipeline: Breakthrough Therapy for NSCLC With Specific Mutation, Approval of Test for Cervical Cancer, and More
Over the past week, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to a bispecific antibody for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations; granted approval to a test for human...
HAPLO2019: Advances in Haploidentical Transplantation and Other Novel Cellular Therapies
Now in its seventh year, the Haploidentical Transplant Symposium (HAPLO) continues to explore advances in haploidentical and other novel cellular therapies. The most recent of these meetings—HAPLO2019—met in Orlando, Florida, 2 days before the start of the 2019 American Society of Hematology (ASH)...
FDA Approves Nivolumab/Ipilimumab for Pretreated Patients With Hepatocellular Carcinoma
On March 10, the U.S. Food and Drug Administration (FDA) granted accelerated approval to the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) for patients with hepatocellular carcinoma who have been previously treated with sorafenib. CheckMate 040 Efficacy of the combination was...
Tazemetostat for Advanced Epithelioid Sarcoma
On January 23, 2020, tazemetostat was granted accelerated approval for the treatment of adults and pediatric patients aged 16 and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.1,2 Supporting Efficacy Data Approval was based on the finding of...
Avapritinib for Gastrointestinal Stromal Tumor With PDGFRA Exon 18 Mutation
On January 9, 2020, avapritinib was approved for treatment of adults with unresectable or metastatic gastrointestinal stromal tumors (GIST) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including D842V mutations.1,2 It is the first therapy approved for...
Expert Point of View: James N. Gerson, MD
James N. Gerson, MD, Assistant Professor of Medicine at Perelman School of Medicine, University of Pennsylvania, Philadelphia, commented on the implications of the findings from CAPTIVATE. “Upfront therapy for chronic lymphocytic leukemia (CLL) is rapidly evolving. We now have three...
Acalabrutinib Plus Obinutuzumab Superior to Obinutuzumab Plus Chlorambucil as Front-Line Treatment of CLL
Ibrutinib was the first Bruton’s tyrosine kinase (BTK) inhibitor to dramatically transform the treatment of patients with chronic lymphocytic leukemia (CLL) and other hematologic malignancies. The second-generation BTK inhibitor acalabrutinib is a more selective BTK inhibitor designed to have an...
PD-L1 Expression Testing
Vamsi Velcheti, MD, and David Rimm, MD, PhD, discuss the high number of recent programmed death ligand 1 (PD-L1) inhibitor approvals and the need to harmonize the various diagnostic assay developments across the supporting clinical trials. Dr. Rimm notes the important difference between companion...
Expert on Public Health and Policy Looks at Precision Oncology
A study published in JAMA Oncology found that 31 genome-targeted anticancer agents were in use as of January 2018.1 To shed light on the current state of precision oncology, The ASCO Post recently spoke with David M. Cutler, PhD, the Otto Eckstein Professor of Applied Economics in the Department of ...
FDA Pipeline: Priority Review in DLBCL, Fast Track Designations in T-Cell Lymphoma and Adenoid Cystic Carcinoma
Over the past week, the U.S. Food and Drug Administration (FDA) granted Priority Review to a combination therapy in diffuse large B-cell lymphoma (DLBCL); gave Fast Track designations for treatments in T-cell lymphoma and adenoid cystic carcinoma; granted Orphan Drug designation to an agent for the ...
Former FDA Commissioner Scott Gottlieb, MD, Relays Opinions on Coronavirus
Scott Gottlieb, MD, former Commissioner of the U.S. Food and Drug Administration (FDA), had some advice for attendees of the 37th Annual Miami Breast Cancer Conference in his keynote address at the meeting. While his formal presentation pertained to innovations in oncology drug development and...
Adding Capecitabine to Systemic Therapies Improves Outcomes in Triple-Negative Breast Cancer
Capecitabine improves disease-free and overall survival for patients with triple-negative breast cancer, but only when it is added to other systemic therapies, not when it is used as a substitute, according to a large meta-analysis of the effects of capecitabine in early breast cancer, The results...
Phase III HER2CLIMB Trial Yields Positive Data in Patients With HER2-Positive Metastatic Breast Cancer and Brain Metastasis
The investigational oral agent tucatinib added to trastuzumab/capecitabine reduced the risk of death by one-third and reduced the risk of disease progression or death by one-half in patients with heavily pretreated metastatic HER2-positive breast cancer, including those with untreated or previously ...
