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Showing 751 - 800NCCN Updates Recommendations on COVID-19 Vaccination and Preexposure Prophylaxis
Today, the National Comprehensive Cancer Network® (NCCN®) published significant updates to the expert consensus recommendations on vaccination and preexposure prophylaxis of COVID-19 for people with cancer. The NCCN Advisory Committee on COVID-19 Vaccination and Preexposure Prophylaxis meets...
Association of Response Rate and Event-Free Survival With Overall Survival in Newly Diagnosed AML: FDA Analysis
In a trial-level analysis of randomized studies submitted to the U.S. Food and Drug Administration (FDA) reported in the Journal of Clinical Oncology, Norsworthy et al found that complete remission rate was moderately correlated, and event-free survival was strongly correlated, with overall...
FDA Takes Multiple Actions to Expand Use of Pfizer-BioNTech COVID-19 Vaccine
On January 3, the U.S. Food and Drug Administration (FDA) amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to expand the use of a single booster dose to include use in individuals aged 12 to 15 years; shorten the time between the completion of primary...
Cures 2.0 Bill May Increase Diversity in Clinical Trials, Expand Access to Telehealth, Invest in Research
Representatives Diana DeGette (D-CO) and Fred Upton (R-MI) recently introduced new legislation intended to invest in research and deliver more cures to patients. The newly introduced 21st Century Cures 2.0 Act (Cures 2.0) is intended to build on the landmark 21st Century Cures Act, which was signed ...
The Oncology Center of Excellence Encourages Submissions of Applied Regulatory Science Research Proposals
OCE Insights is an occasional column developed for The ASCO Post by members of the Oncology Center of Excellence (OCE) at the U.S. Food and Drug Administration (FDA). In this installment, Julie A. Schneider, PhD, Associate Director for Research Strategy and Partnerships, OCE; Jennifer J. Gao, MD,...
Daratumumab in Front-Line Treatment of Newly Diagnosed Transplant-Ineligible Multiple Myeloma: Questions Emerge From MAIA Trial
In the past decade, use of immunotherapy has arisen as a novel adjunct to multiple myeloma therapy. Daratumumab is the first anti-CD38 monoclonal antibody to be approved by the U.S. Food and Drug Administration (FDA), in November 2015, for use in treating relapsed or refractory multiple myeloma.1...
ASH Recognizes Peter Marks, MD, PhD, With 2021 Outstanding Service Award
The American Society of Hematology (ASH) recognized Peter Marks, MD, PhD, Director of the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA), for his outstanding commitment to hematology in overseeing the approval of therapeutics that improve the...
MAIA Trial: Daratumumab Added to Lenalidomide Plus Dexamethasone Improves Overall Survival in Transplant-Ineligible Multiple Myeloma
As reported in The Lancet Oncology by Thierry Facon, MD, of the Centre Hospitalier Universitaire de Lille, and colleagues, a prespecified interim analysis of overall survival in the pivotal phase III MAIA trial has shown a significant benefit with the addition of daratumumab to...
Identifying Women With Triple-Negative Breast Cancer Who May Benefit From Pembrolizumab Plus Chemotherapy
Results of the phase III randomized KEYNOTE-355 trial showed that the addition of the PD-1 inhibitor pembrolizumab to investigator’s choice of first-line chemotherapy improved progression-free and overall survival in women with metastatic triple-negative breast cancer compared with placebo and...
Leslie S. Kean, MD, PhD, on Bone Marrow Transplantation: Using Abatacept to Prevent Graft-vs-Host Disease
Leslie S. Kean, MD, PhD, of Dana-Farber/Boston Children's Cancer and Blood Disorders Center, discusses findings from her analysis of the International Blood and Marrow Transplant Research Database, which led to the recent FDA approval of abatacept for the prevention of acute graft-vs-host disease...
2021 FDA Approvals of Drugs for Cancer Treatment
Over the past year, the U.S. Food and Drug Administration (FDA) granted approval to many novel drugs and new indications for older therapeutic agents used in oncology and hematology. NOVEMBER Pafolacianine for Ovarian Cancer Lesions: On November 29, pafolacianine (Cytalux), an imaging drug,...
FDA Approves Abatacept-Based Combination for Prophylaxis of Acute Graft-vs-Host Disease
On December 15, the U.S. Food and Drug Administration (FDA) approved abatacept (Orencia) for the prophylaxis of acute graft-vs-host disease (GVHD), in combination with a calcineurin inhibitor and methotrexate, in adults and pediatric patients aged 2 years and older undergoing hematopoietic stem...
Ivosidenib/Azacitidine vs Azacitidine Alone in Patients With Newly Diagnosed IDH1-Mutated AML
In the phase III AGILE trial, the combination of ivosidenib and azacitidine was found to be superior in treating newly diagnosed patients with IDH1-mutated acute myeloid leukemia (AML) compared to azacitidine alone in terms of event-free survival, the study’s primary endpoint. The combination also...
The National Cancer Act of 1971
On December 23, 1971, President Richard M. Nixon signed the National Cancer Act into law. At that time, cancer was the nation’s second leading cause of death; only about one of two people diagnosed with cancer survived at least 5 years—compared with two of three people diagnosed with the disease...
Abemaciclib With Endocrine Therapy in Adjuvant Treatment of Early Breast Cancer
On October 12, 2021, abemaciclib was approved for use with endocrine therapy (tamoxifen or an aromatase inhibitor) for adjuvant treatment of adults with hormone receptor–positive, HER2-negative, node-positive, early breast cancer at high risk of recurrence and a Ki67 score ≥ 20%, as determined by...
Atezolizumab in Adjuvant Therapy for PD-L1–Positive NSCLC
On October 15, 2021, atezolizumab was approved for adjuvant treatment following resection and platinum-based chemotherapy in patients with stage II to IIIA non–small cell lung cancer (NSCLC) with PD-L1 expression on ≥ 1% of tumor cells, as determined by a U.S. Food and Drug Administration...
FDA Approves Pembrolizumab for the Adjuvant Treatment of Stage IIB or IIC Melanoma
On December 3, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for the adjuvant treatment of adult and pediatric patients aged 12 years and older with stage IIB or IIC melanoma following complete resection. KEYNOTE-716 Efficacy was evaluated in KEYNOTE-716, a...
Impact of Time of Day of Immune Checkpoint Inhibitor Infusion on Overall Survival in Advanced Melanoma
On this episode, we’ll hear about a study that examined the impact of the time of day that a patient with advanced melanoma receives an immune checkpoint inhibitor infusion on overall survival. Then, we’ll hear about two recent approvals from the FDA—one in relapsed or refractory multiple myeloma,...
FDA Approves Rituximab Plus Chemotherapy for Several Pediatric Hematologic Malignancies
On December 2, the U.S. Food and Drug Administration (FDA) approved rituximab (Rituxan) in combination with chemotherapy for pediatric patients (≥ 6 months to < 18 years old) with previously untreated, advanced-stage, CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma,...
FDA Approves Triplet Therapy for Previously Treated Patients With Relapsed or Refractory Multiple Myeloma
On November 30, the U.S. Food and Drug Administration (FDA) approved daratumumab and hyaluronidase-fihj (Darzalex Faspro) in combination with carfilzomib (Kyprolis) plus dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of...
Long-Term Follow-up of monarchE: Benefit of Abemaciclib Plus Endocrine Therapy Maintained in Early High-Risk Breast Cancer
Longer-term follow-up of the global phase III monarchE trial showed an increasing benefit for adding abemaciclib to endocrine therapy in the adjuvant treatment of early high-risk hormone receptor–positive, HER2-negative breast cancer, regardless of Ki67 index. The latest findings were reported at a ...
FDA Approves Pafolacianine to Help Identify Ovarian Cancer Lesions
On November 29, the U.S. Food and Drug Administration (FDA) approved pafolacianine (Cytalux), a targeted fluorescent imaging agent intended to assist surgeons in identifying ovarian cancer lesions. The drug, which is indicated for use in adult patients with ovarian cancer and is administered in the ...
FDA Approves Maribavir for Posttransplant CMV
On November 23, the U.S. Food and Drug Administration (FDA) approved the antiviral maribavir (Livtencity) for adult and pediatric patients aged 12 years and older (and weighing at least 35 kg) with posttransplant cytomegalovirus (CMV) infection or disease that is not responsive (with or without...
Adjuvant Immunotherapy: The Next Chapter in Advancements in Renal Cell Carcinoma
Renal cell carcinoma is a common malignancy among men and women in the United States.1 The incidence continues to increase with the ever-increasing use of contemporary medical imaging. Although many patients who present with localized disease are cured with definitive surgery, some patients develop ...
FDA Pipeline: Reviews and Designations in Hematology
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to a gene therapy for patients with β-thalassemia, and Fast Track designation to a SETD2 inhibitor for patients with relapsed or refractory diffuse large B-cell lymphoma. Priority Review: Betibeglogene Autotemcel for...
FDA 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...
