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Showing 701 - 750Identifying 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...
FDA Approves FoundationOne CDx as a Companion Diagnostic for Pembrolizumab to Identify Patients With MSI-H Solid Tumors
On February 21, the U.S. Food and Drug Administration (FDA) approved FoundationOne CDx to be used as a companion diagnostic to identify patients with microsatellite instability–high (MSI-H) status solid tumors who may be appropriate candidates for treatment with pembrolizumab. FoundationOne CDx is...
Isatuximab-Containing Induction Therapy for Multiple Myeloma Increases Measurable Residual Disease Negativity
For the first-line treatment of newly diagnosed multiple myeloma, the percentage of patients achieving measurable residual disease (MRD, previously called minimal residual disease) negativity was significantly greater when the anti-CD38 monoclonal antibody isatuximab was added to a standard...
Why Some Patients With Cancer Are Reluctant to Receive COVID-19 Vaccination: Survey Shows Need to Improve Patient-Physician Communication
“My doctor has not told me to get the vaccine.” That was the number one reason patients with cancer gave in a survey at an outpatient infusion therapy clinic for not having received at least one dose of the COVID-19 vaccine. Rivalling that reason were concerns about safety and fear of vaccine side...
Expert Point of View: Susan M. O’Brien, MD
The GAIA trial raises some important points, according to Susan M. O’Brien, MD, Associate Director for Clinical Research at the UCI Chao Family Comprehensive Cancer Center in Irvine, California. Dr. O’Brien co-moderated the session where Dr. Eichhorst presented study results. “The CLL14 trial...
Expert Point of View: Susan M. O’Brien, MD
The GAIA trial raises some important points, according to Susan M. O’Brien, MD, Associate Director for Clinical Research at the UCI Chao Family Comprehensive Cancer Center in Irvine, California. Dr. O’Brien co-moderated the session where Dr. Eichhorst presented study results. “The CLL14 trial...
Robert M. Califf, MD, MACC, Confirmed as FDA Commissioner
On February 15, the Senate voted 50 to 46 to confirm Robert M. Califf, MD, MACC, as Commissioner of the U.S. Food and Drug Administration (FDA). Dr. Califf was previously the Commissioner of the FDA from February 2016 to January 2017. He also served as the FDA’s Deputy Commissioner for Medical...
Report Finds Cancer Immunotherapy Clinical Trials Continue to Grow Globally
The Cancer Research Institute (CRI), a nonprofit organization dedicated to the discovery and development of powerful immunotherapies for all types of cancer, has announced the publication of a new analysis of the global landscape of clinical development of drugs that target the PD-1/PD-L1 immune...
Importing Oncology Trials From China, or Other Single Foreign Countries, for Consideration of U.S. Regulatory Approvals
In a commentary published in The Lancet Oncology, Harpreet Singh, MD, and Richard Pazdur, MD, both of the Oncology Center of Excellence at the U.S. Food and Drug Administration (FDA), warned against the increasing number of oncology drug development programs based wholly or predominantly on data...
Oncology Drugs With Accelerated Approval: Is It Time for a Reset?
Regulations that are developed by the U.S. Food and Drug Administration (FDA) must have some shelf-life before revisions are considered. The FDA has several mechanisms to provide patients with more rapid access to medicines. One such pathway is accelerated approval. Backward Glance at Accelerated...
AACR Releases Report on the Impact of COVID-19 on Cancer Research and Patient Care
On February 9, the American Association for Cancer Research (AACR) released the AACR Report on the Impact of COVID-19 on Cancer Research and Patient Care. According to findings contained within the report, patients with cancer are not only at an increased risk for developing severe COVID-19, but...
FDA Investigating Possible Increased Risk of Death With Lymphoma Treatment Umbralisib
The U.S. Food and Drug Administration (FDA) is investigating a possible increased risk of death associated with umbralisib (Ukoniq), a kinase inhibitor including PI3K-delta and CK1-epsilon, approved to treat marginal zone and follicular lymphomas. The FDA determined that initial findings from the...
President Biden Reignites Cancer Moonshot
As Vice President, in 2016, Joe Biden launched the Cancer Moonshot with the mission to accelerate the rate of progress against cancer. The cancer and patient community and medical researchers responded with energy and ingenuity. On February 2, President Biden announced the reigniting of the Cancer ...
FDA Approves New Label Update for CAR T-Cell Therapy Axicabtagene Ciloleucel
On January 31, the FDA approved an update to the prescribing information for axicabtagene ciloleucel (Yescarta) to include use of prophylactic corticosteroids across all approved indications. Axicabtagene ciloleucel is now the first and only chimeric antigen receptor (CAR) T-cell therapy with...
FDA Approves Second COVID-19 Vaccine
On January 31, the U.S. Food and Drug Administration (FDA) approved a second COVID-19 vaccine, which has been known as the Moderna COVID-19 vaccine, for the prevention of COVID-19 in individuals aged 18 years and older; the approved vaccine will be marketed as Spikevax. “The FDA’s approval of [the...
Assessing Value in Gastrointestinal Cancer Treatments
The era of precision oncology, in which molecular biomarkers are used to help guide drug delivery, has dovetailed with the emerging issues of value-based care and cost containment. To shed light on these issues and more, The ASCO Post spoke with Hanna K. Sanoff, MD, MPH, Clinical Medical Director...
FDA Approval in Metastatic Uveal Melanoma
On this episode, we’ll be talking about an FDA approval for uveal melanoma, as well as the efficacy of PD-1 inhibition in patients with resectable liver cancer.
FDA Approves Tebentafusp-tebn for the Treatment of Unresectable or Metastatic Uveal Melanoma
On January 26, the U.S. Food and Drug Administration (FDA) granted approval to tebentafusp-tebn (Kimmtrak) for the treatment of adult patients with HLA-A*02:01–positive, unresectable or metastatic uveal melanoma. Tebentafusp’s approval establishes several firsts: as the first T-cell receptor...
Project Catalyst: Educating Industry to Help Develop Successful Cancer Therapies
OCE Insights is written by members of the Oncology Center of Excellence (OCE) and the Office of Oncology Diseases (OOD) at the U.S. Food and Drug Administration. In this installment, Jeff Summers, MD, OOD Acting Associate Director for Translational Sciences, and Marc R. Theoret, MD, OCE Deputy...
Adjuvant Atezolizumab in IMpower010: Moving the Needle in Early-Stage NSCLC
Adjuvant platinum-based chemotherapy for early-stage non–small cell lung cancer (NSCLC) is currently almost an afterthought and is taken for granted as a standard of care for patients with stage II to IIIA NSCLC after resection. The earliest meta-analysis, published in 1995,1 gave the first hint of ...
Pembrolizumab Plus Chemotherapy in Advanced Esophageal Cancer: Good News for Some, but More Work to Be Done
Multiple comparisons of traditional cytotoxic chemotherapy combinations that began decades ago led to the adoption of the platinum plus fluorouracil doublet as the standard of care for treatment of recurrent or metastatic esophageal cancer.1 Other combinations created by the addition and/or...
Isatuximab-Containing Induction Therapy for Multiple Myeloma Increases Measurable Residual Disease Negativity
For the first-line treatment of newly diagnosed multiple myeloma, the percentage of patients achieving measurable residual disease (MRD, previously called minimal residual disease) negativity was significantly greater when the anti-CD38 monoclonal antibody isatuximab was added to a standard...
Better Federal Agency Coordination Is Needed to Accelerate Progress Against Cancer
President Richard M. Nixon signed the National Cancer Act into law on December 23, 1971. The unprecedented legislation granted sweeping authority to the Director of the National Cancer Institute (NCI) to develop a national cancer program that included the NCI, other research institutes, and federal ...
FDA Shortens Interval for Booster Dose of Moderna COVID-19 Vaccine to 5 Months
On January 7, the U.S. Food and Drug Administration (FDA) amended the emergency use authorization (EUA) for the Moderna COVID-19 vaccine to shorten the time between the completion of a primary series of the vaccine and a booster dose to at least 5 months for individuals aged 18 years and older....
Portable Prostate Cancer Screening Test May Help Reach Underserved Patients
A portable, rapid prostate cancer screening kit could provide early warning to populations with a higher incidence of prostate cancer and may particularly aid those with limited access to health care. The proof-of-concept test, described by Srinivasan et al in Current Research in Biotechnology, is...
NCCN 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...
