Search Results
Your search for ,Fda matches 3728 pages
Showing 751 - 800FDA Approves Sirolimus Protein-Bound Particles for Rare Sarcoma
On November 22, the U.S. Food and Drug Administration (FDA) approved sirolimus protein-bound particles for injectable suspension (albumin-bound; Fyarro) for adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa). AMPECT Trial Efficacy ...
Pembrolizumab Plus Chemotherapy With or Without Bevacizumab in First-Line Treatment of Advanced Cervical 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 October 13, 2021, pembrolizumab in combination with...
Novel Therapies Under Study in Acute Myeloid Leukemia
Newly identified genetic abnormalities in acute myeloid leukemia (AML), as well as therapies that can target some of those abnormalities, are now available as the landscape for treatment continues to evolve. During the 2021 National Comprehensive Cancer Network (NCCN) Annual Congress: Hematologic...
Friends of Cancer Research Releases White Paper on Optimizing Dosing in Oncology Drug Development
During its virtual Annual Meeting 2021 held on November 9 and 10, Friends of Cancer Research (Friends) urged all stakeholders in the cancer community to work together to optimize dosing in oncology drug development to maximize benefit for patients and reduce treatment toxicity, and to abandon the...
Novel Therapies Under Study in Acute Myeloid Leukemia
Newly identified genetic abnormalities in AML have led to novel therapies that can target some of them, as the landscape for treatment continues to evolve. During the 2021 National Comprehensive Cancer Network (NCCN) Annual Congress: Hematologic Malignancies, Alice S. Mims MD, presented updates in...
Newer Agents on the Horizon for Refractory or Relapsed DLBCL
Although treating patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) remains challenging, some newer therapies on the horizon offer promise, including bispecific antibodies, anti-CD47 antibodies, antibody-drug conjugates, and chimeric antigen receptor (CAR) T-cell therapy,...
FDA Expands Eligibility for COVID-19 Vaccine Boosters
On November 19, the U.S. Food and Drug Administration (FDA) amended the emergency use authorizations (EUA) for both the Moderna and Pfizer-BioNTech COVID-19 vaccines authorizing use of a single booster dose for all individuals aged 18 years and older after completion of primary vaccination with any ...
FDA Approves Pembrolizumab for Adjuvant Treatment of Renal Cell Carcinoma
On November 17, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for the adjuvant treatment of patients with renal cell carcinoma (RCC) at intermediate-high or high risk of disease recurrence following nephrectomy or nephrectomy and resection of metastatic lesions....
Numerous Regimens Proposed for Relapsed or Refractory Myeloma
Although patients with multiple myeloma can respond to initial treatment, once a patient has had three or four different types of therapy, and the disease is deemed relapsed or refractory, treatment becomes more complicated. This is related to both clinical characteristics, as patients may develop...
FDA Approves Ropeginterferon alfa-2b-njft for Adults With Polycythemia Vera
The U.S. Food and Drug Administration (FDA) has approved ropeginterferon alfa-2b-njft (Besremi) for the treatment of adults with polycythemia vera. The new agent is a monopegylated, long-acting interferon, which exhibits its cellular effects in polycythemia vera in the bone marrow. Ropeginterferon...
President Biden Nominates Robert M. Califf, MD, MACC, as FDA Commissioner
President Joseph Biden has nominated Robert M. Califf, MD, MACC, for the position of Commissioner of the U.S. Food and Drug Administration (FDA). Dr. Califf is an internationally recognized expert in clinical trial research, health disparities, health-care quality, and cardiovascular medicine....
Showcasing 50 Years of Advances in Cancer Research and Treatment
The AACR Cancer Progress Report 2021, published on October 13, celebrates the gains made in cancer research since President Richard Nixon signed the National Cancer Act into law on December 23, 1971, especially against such life-threatening cancers as metastatic melanoma and lung cancer.1 The...
CDK4/6 Inhibitors Combined With Fulvestrant for Hormone Receptor–Positive, HER2-Negative Advanced Breast Cancer: FDA Analysis of Overall Survival
In an exploratory U.S. Food and Drug Administration (FDA) pooled analysis reported in The Lancet Oncology, Jennifer J. Gao, MD, and colleagues found that the addition of CDK4/6 inhibitor treatment to fulvestrant resulted in a consistent overall survival benefit vs placebo plus fulvestrant in...
IMpower010: Adjuvant Atezolizumab Improves Disease-Free Survival and NSCLC Relapse in Patients Whose Tumors Express PD-L1
Adjuvant immunotherapy with atezolizumab after standard chemotherapy improved disease-free survival and time to locoregional and distant relapse compared with best supportive care in prespecified subgroups of patients with stage II to IIIA non–small cell lung cancer (NSCLC), according to an...
FDA Pipeline: Novel Treatments in Lymphoma, Nasopharyngeal Cancer, Solid Tumors, and More
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to agents for several kinds of lymphoma, as well as nasopharyngeal cancer; a Breakthrough Therapy designation for a treatment for patients with NTRK-positive advanced solid tumors; and Fast Track designation for...
Karen M. Winkfield, MD, PhD, on Digital Health to Improve Patient Outcomes and Experience
Karen M. Winkfield, MD, PhD, of Vanderbilt University Medical Center, who co-chaired a session (PS 02) on digital health, summarizes the talks, which included ways to reduce disparities with digital innovations and the importance of patient input, especially in the form of patient-reported outcomes ...
FDA Approves Asciminib for Philadelphia Chromosome–Positive CML
On October 29, the U.S. Food and Drug Administration (FDA) granted accelerated approval to the kinase inhibitor asciminib (Scemblix) for patients with Philadelphia chromosome–positive chronic myeloid leukemia (Ph+ CML) in chronic phase who have been previously treated with two or more tyrosine...
FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children Aged 5 Through 11 Years
On October 29, the U.S. Food and Drug Administration (FDA) authorized the emergency use of the Pfizer-BioNTech COVID-19 vaccine for the prevention of COVID-19 to include children aged 5 through 11 years. The authorization was based on the FDA’s thorough and transparent evaluation of the data that...
Melphalan Flufenamide Withdrawn From the U.S. Market
On October 22, Oncopeptides announced its decision to withdraw melphalan flufenamide (Pepaxto), a first-in-class peptide-drug conjugate, from the market in the United States, following results from the phase III OCEAN study in patients with relapsed or refractory multiple myeloma. The decision to...
FDA Expands Cetuximab Label for Encorafenib Combination in BRAF V600E Mutation–Positive Metastatic Colorectal Cancer
The U.S. Food and Drug Administration (FDA) has granted approval of a new indication for the EGFR inhibitor cetuximab (Erbitux) in combination with encorafenib (Braftovi) for the treatment of adults with metastatic colorectal cancer and a BRAF V600E mutation, as detected by an FDA-approved test,...
Mobocertinib for Previously Treated Advanced NSCLC With EGFR Exon 20 Insertion Mutations
On September 15, 2021, the kinase inhibitor mobocertinib was granted accelerated approval by the U.S. Food and Drug Administration (FDA) for adults with locally advanced or metastatic non–small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, as detected by an FDA-approved test,...
Activity of Nab-sirolimus in Malignant Perivascular Epithelioid Cell Tumors
In the phase II AMPECT trial reported in the Journal of Clinical Oncology, Wagner et al found that the mTOR inhibitor nab-sirolimus produced a substantial rate of durable responses and a high disease control rate in patients with malignant perivascular epithelioid cell tumors. As stated by the...
FDA Perspective on Drug-Dosing in Oncology: From ‘More Is Better’ to ‘Less Can Be More’
In a perspective article published in The New England Journal of Medicine entitled “The Drug-Dosing Conundrum in Oncology—When Less Is More,” four authors from the U.S. Food and Drug Administration (FDA) argue for the need to jettison the “more is better” paradigm in dose selection for oncology...
FDA Approvals in Breast and Cervical Cancers
This week, the FDA approved new indications for two drugs. The first approval was for abemaciclib in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor–positive, HER2-negative, node-positive, early breast...
FDA Approves Atezolizumab as Adjuvant Treatment for NSCLC
On October 15, the U.S. Food and Drug Administration (FDA) approved atezolizumab (Tecentriq) for adjuvant treatment following resection and platinum-based chemotherapy in patients with stage II to IIIA non–small cell lung cancer (NSCLC) whose tumors have PD-L1 expression on ≥ 1% of tumor cells, as...
Characteristics of Genomically Targeted Single-Patient Use Requests for Pediatric Cancers
In a study reported in the Journal of Clinical Oncology, Sabnis et al analyzed characteristics of genomically targeted single-patient use requests for investigational agents for the treatment of pediatric cancers. These requests were made from pediatric cancer programs over a 5-year period. As...
AACR Cancer Progress Report 2021 Showcases 50 Years of Advances in Cancer Research and Treatment
The AACR Cancer Progress Report 2021 celebrates the gains made in cancer research since the National Cancer Act was signed into law on December 23, 1971. The report also recognizes the negative impact the COVID-19 pandemic has had on cancer research and patient care, the disproportionate toll both...
FDA Approves Pembrolizumab Combination for the First-Line Treatment of Cervical Cancer
On October 13, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) in combination with chemotherapy, with or without bevacizumab, for patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (combined positive score [CPS] ≥ 1), as...
FDA Approves Abemaciclib in Combination With Endocrine Therapy for Early Breast Cancer
On October 12, the U.S. Food and Drug Administration (FDA) approved abemaciclib (Verzenio) in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, HER2-negative, node-positive early breast cancer...
Recent FDA Approvals in Breast Cancer
In the past year, the U.S. Food and Drug Administration (FDA) approved five treatment options for patients with breast cancer, which are summarized herein. Abemaciclib Combination On October 12, 2021, the FDA approved abemaciclib (Verzenio) with endocrine therapy (tamoxifen or an aromatase...
Expert Point of View: Yuan Yuan, MD, PhD and Elizabeth Mittendorf, MD, PhD
Yuan Yuan, MD, PhD, a medical oncologist at City of Hope, Duarte, California, weighed in on the KEYNOTE-355 findings. “The study presented by Dr. Rugo on KEYNOTE-355 reconfirms the utility of adding immune checkpoint inhibitors to chemotherapy as front-line treatment for metastatic triple-negative ...
KEYNOTE-355: Pembrolizumab Plus Chemotherapy Improves Progression-Free Survival in PD-L1–Enriched Advanced Triple-Negative Breast Cancer
Pembrolizumab plus chemotherapy improved progression-free survival vs chemotherapy alone as first-line treatment of advanced or metastatic triple-negative breast cancer, according to the results of KEYNOTE-355.1 Progression-free survival was significantly improved with pembrolizumab plus...
KEYNOTE-522: Neoadjuvant Pembrolizumab Improves Event-Free Survival in Triple-Negative Breast Cancer
The latest analysis of the phase III KEYNOTE-522 trial demonstrated significant improvements in clinical outcomes with pembrolizumab plus chemotherapy vs chemotherapy alone as a neoadjuvant/adjuvant treatment of triple-negative breast cancer.1 This is the first large, randomized, phase III trial to ...
Early Triple-Negative Breast Cancer: Are Checkpoint Inhibitors Ready for Neoadjuvant or Adjuvant Use?
Recent clinical trials have been encouraging for the neoadjuvant or adjuvant use of immune checkpoint inhibitors in triple-negative breast cancer, but is this approach ready for the clinic? This question was addressed at the 38th Miami Breast Cancer Conference, held virtually this year, by Adam M....
Novel HER2-Targeted Therapies Pose Sequencing Challenges
With three new HER2-targeted therapies approved over the past year or two alone, the treatment landscape for patients with metastatic breast cancer has become increasingly crowded. In the third-line setting and beyond, there are now at least eight HER2-targeted agents approved by the U.S. Food and...
OlympiA Trial: Adjuvant Olaparib Extends Disease-Free Survival in BRCA-Mutated Early Breast Cancer
Adjuvant therapy with the PARP inhibitor olaparib for 1 year extended disease-free survival in patients with high-risk early-stage HER2-negative breast cancer with BRCA1/2 germline (inherited) mutations, according to a prespecified interim analysis of the phase III OlympiA trial presented at the...
FDA Pipeline: Recent Reviews, Designations, Applications, and Authorizations in the Oncology Space
Over the past month, the U.S. Food and Drug Administration (FDA) issued several regulatory decisions for novel treatments for patients with cancer. Priority Review for Relatlimab and Nivolumab Fixed-Dose Combination in Unresectable or Metastatic Melanoma The FDA accepted for Priority Review the...
FDA Recognizes Memorial Sloan Kettering Database of Molecular Tumor Marker Information
On October 7, the U.S. Food and Drug Administration (FDA) granted recognition to a partial listing of the Memorial Sloan Kettering Cancer Center Oncology Knowledge Base (OncoKB) as the first tumor mutation database to be included in the Public Human Genetic Variant Databases. The FDA recognized a...
Maintenance Durvalumab: Increased Utilization May Improve Outcomes in NSCLC
Maintenance durvalumab, the standard-of-care treatment for patients with unresectable stage III non–small cell lung cancer (NSCLC), remains significantly underutilized, according to data presented at the International Association for the Study of Lung Cancer (IASLC) 2021 World Conference on Lung...
Adding Value to Clinical Decision-Making in Nonmetastatic Castration-Resistant Prostate Cancer
Several recent investigations have led to the U.S. Food and Drug Administration (FDA) approval of novel antiandrogens to treat nonmetastatic castration-resistant prostate cancer. Yet, this work has not addressed the treatment of nonmetastatic hormone-sensitive biochemically recurrent prostate...
FDA Approves Brexucabtagene Autoleucel for Relapsed or Refractory B-Cell Precursor ALL
On October 1, the U.S. Food and Drug Administration (FDA) approved brexucabtagene autoleucel (Tecartus), a CD19-directed chimeric antigen receptor (CAR) T-cell therapy, for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). ZUMA-3 Efficacy was evaluated ...
FDA Expands Cetuximab Label With Combination of Encorafenib for Pretreated BRAF V600E Mutation–Positive Metastatic Colorectal Cancer
The U.S. Food and Drug Administration (FDA) has granted approval of a new indication for cetuximab (Erbitux) in combination with encorafenib (Braftovi) for the treatment of adult patients with metastatic colorectal cancer and a BRAF V600E mutation, as detected by an FDA-approved test, after prior...
Classifying EGFR Mutations by Structure and Function May Help to Match Patients With NSCLC to More Effective Treatments
Researchers have discovered that grouping EGFR mutations by structure and function provides an accurate framework to match patients with non–small cell lung cancer (NSCLC) to the right drugs. The findings, published by Robichaux et al in Nature, identify four subgroups of mutations and introduce a...
Ivosidenib for Previously Treated IDH1-Mutant Advanced or Metastatic Cholangiocarcinoma
On August 25, 2021, ivosidenib was approved for adults with previously treated, locally advanced or metastatic cholangiocarcinoma with an IDH1 mutation, as detected by a U.S. Food and Drug Administration (FDA)-approved test.1 The FDA simultaneously approved the Oncomine Dx Target Test as a...
Dostarlimab-gxly for Mismatch Repair–Deficient Recurrent or Advanced Solid Tumors
On August 17, 2021, dostarlimab-gxly, aPD-1 blocking monoclonal antibody, was granted accelerated approval for adults with mismatch repair–deficient (dMMR) recurrent or advanced solid tumors, as determined by a U.S. Food and Drug Administration (FDA)-approved test, who have had disease progression...
ASCO 2021: Roundup of Studies You May Have Missed
As ASCO Annual Meeting attendees know by now, clinicians don’t have to be at McCormick Place to hear practice-changing findings and forward-looking advances in the field of oncology. Interesting content was no exception at the 2021 conference, so in addition to covering the biggest news from the...
FDA Authorizes Booster Dose of Pfizer-BioNTech COVID-19 Vaccine for Certain Populations
The U.S. Food and Drug Administration (FDA) has amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to allow for the use of a single booster dose to be administered at least 6 months after completion of the primary series in individuals aged 65 years and older;...
Ruxolitinib Granted FDA Approval for Chronic Graft-vs-Host Disease
On September 22, the U.S. Food and Drug Administration approved ruxolitinib (Jakafi), a JAK inhibitor, for the treatment of chronic graft-vs-host disease (GVHD) after failure of one or two lines of systemic therapy in adult and pediatric patients aged 12 years and older. REACH3 Efficacy was...
FDA Grants Accelerated Approval to Tisotumab Vedotin-tftv for Recurrent or Metastatic Cervical Cancer
On September 20, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tisotumab vedotin-tftv (Tivdak), a tissue factor–directed antibody and microtubule inhibitor conjugate, for adult patients with recurrent or metastatic cervical cancer who experienced disease progression on ...
FDA Approves Cabozantinib for Patients With Previously Treated Radioactive Iodine–Refractory Differentiated Thyroid Cancer
On September 17, the U.S. Food and Drug Administration (FDA) approved cabozantinib (Cabometyx) for the treatment of adult and pediatric patients aged 12 years and older with locally advanced or metastatic differentiated thyroid cancer that has progressed following prior vascular endothelial growth...
