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Showing 701 - 750Norman Sharpless, MD, to Step Down as Director of the NCI
Norman E. Sharpless, MD, has announced that he has decided to step down from his position as Director of the National Cancer Institute (NCI), part of the National Institutes of Health, a position he has held since 2017. Dr. Sharpless will continue as NCI Director through April 29, 2022, to allow...
FDA Approves Axicabtagene Ciloleucel for the Second-Line Treatment of Large B-Cell Lymphoma
On April 1, the U.S. Food and Drug Administration (FDA) approved axicabtagene ciloleucel (Yescarta) for adult patients with large B-cell lymphoma (LBCL) who are refractory to first-line chemoimmunotherapy or who experienced relapse within 12 months of first-line chemoimmunotherapy. It is not...
Study Finds Black Patients With Cancer Diagnosed With COVID-19 Have Worse Outcomes Than White Patients
Black patients with cancer experienced significantly worse outcomes after a COVID-19 diagnosis than non-Hispanic White patients, according to findings published by Fu et al in JAMA Network Open. Investigators from the COVID-19 and Cancer Consortium (CCC19) studied the electronic health records of...
FDA Approvals in Prostate and Endometrial Cancers
In this week’s episode, we are discussing two recent FDA approvals—one for prostate cancer, and the other for endometrial cancer. The radioconjugate lutetium Lu-177 vipivotide tetraxetan was approved for the treatment of adult patients with prostate-specific membrane antigen–positive metastatic...
Recent FDA Approvals in Gastrointestinal Cancer
Over the past year, the U.S. Food and Drug Administration granted approval to several novel drugs and new indications for older therapeutic agents used in gastrointestinal oncology. Cetuximab Plus Encorafenib On September 28, 2021, cetuximab (Erbitux) was approved in combination with encorafenib...
Gastrointestinal Oncology 2021–2022 Almanac
The past year has seen unprecedented progress across the spectrum of gastrointestinal malignances, including the advancement of immunotherapy and targeted molecular agents and the refinement of adjuvant therapy using novel as well as existing therapies. Three themes emerging from these reports are: ...
ASCO Provisional Clinical Opinion Offers Guidance for Using and Interpreting Genomic Testing in Patients With Advanced Cancer
Somatic genomic testing should be a routine part of clinical care for many patients with metastatic or advanced solid tumors, according to a new ASCO provisional clinical opinion.1 As reported in the Journal of Clinical Oncology, the expert panel found that genomic testing in oncology practice has...
FDA Approves Radioligand for Metastatic Castration-Resistant Prostate Cancer
On March 23, the U.S. Food and Drug Administration approved lutetium Lu-177 vipivotide tetraxetan (Pluvicto) for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer who have been treated with androgen receptor...
FDA Approves Pembrolizumab for Advanced Endometrial Carcinoma
On March 21, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) as a single agent for patients with advanced endometrial carcinoma that is microsatellite instability–high or mismatch repair–deficient (as determined by an FDA-approved test). Eligible patients have disease...
FDA Approves Nivolumab/Relatlimab-rmbw for Unresectable or Metastatic Melanoma
On March 18, the U.S. Food and Drug Administration (FDA) approved nivolumab and relatlimab-rmbw (Opdualag) for adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. The approved treatment is a fixed-dose combination of the LAG-3–blocking antibody relatlimab ...
FDA Approval in Germline BRCA-Mutated, HER2-Negative, High-Risk Early-Stage Breast Cancer
In this week’s episode, we’ll discuss a recent U.S. Food and Drug Administration (FDA) approval in germline BRCA-mutated, HER2-negative, high-risk early-stage breast cancer. Then, we’ll hear about the publication of final overall survival results from the MONALEESA-2 trial, which evaluated the...
Genitourinary Oncology 2021–2022 Almanac
The past year has witnessed tremendous advances in genitourinary oncology. I am pleased to review these findings in this year’s Genitourinary Oncology Almanac from The ASCO Post. I hope that you will find this roadmap helpful in highlighting a selection of these exciting developments. Checkpoint...
VISION Trial: Novel PSMA-Targeted Radiotherapy Improves Outcomes in Metastatic Prostate Cancer
Lutetium-177–PSMA-617 (LuPSMA)—an investigational radiolabeled small molecule—significantly improved radiographic progression-free survival and overall survival when added to the standard of care compared with the standard of care alone for men with metastatic castration-resistant prostate cancer...
FDA Approves Olaparib for Adjuvant Treatment of High-Risk Early Breast Cancer
On March 11, the U.S. Food and Drug Administration (FDA) approved olaparib (Lynparza) for the adjuvant treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated, HER2-negative, high-risk early breast cancer who have been treated with neoadjuvant or adjuvant...
First FDA Approval for Neoadjuvant Therapy for Early-Stage NSCLC
In this week’s episode, we’ll discuss a recent U.S. Food and Drug Administration (FDA) approval in the early-stage non–small cell lung cancer setting. Then, we’ll hear about a study presented at the 2022 Multidisciplinary Head and Neck Cancers Symposium that investigated methods for the...
New ASCO Report Clarifies Potential Value and Utility of Biosimilars in Oncology
A new report from an ASCO expert panel that addresses unanswered questions about biosimilars—licensed biologic products that are largely analogous to products approved by the U.S. Food and Drug Administration (FDA)—found that they may represent an affordable and effective alternative for cancer...
Importing Oncology Trials From China, or Other Single Foreign Countries, for Consideration of U.S. Regulatory Approvals
In a commentary published recently in The Lancet Oncology,1 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...
Project Confirm: An Initiative to Promote Transparency of the Accelerated Approval Program for Oncology Indications
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, Gautam U. Mehta, MD, Neurosurgical Oncologist and Clinical Reviewer, Division of Oncology 2; Fatima Rizvi,...
Report on COVID-19 Outlines the Pandemic’s Negative Impact on Patient Care and Clinical Research—and the Lessons Learned
Patients with cancer are not only at an increased risk for developing severe COVID-19, but also face cancer treatment delays and interruptions due to the pandemic, potentially worsening cancer outcomes, according to the AACR Report on the Impact of COVID-19 on Cancer Research and Patient Care. In...
Emerging Issues Regarding Artificial Intelligence in Cancer Research and Clinical Practice
Artificial intelligence (AI) has captured society’s imagination and generated enthusiasm for its potential to improve our quality of life, especially in the health-care arena. The availability of high-dimensionality data sets along with innovations in high-performance computing and deep-learning...
President’s Cancer Panel Report: Closing Gaps in Cancer Screening for All Americans
Much progress has been made in the past 50 years since the signing of the National Cancer Act of 1971, which included the establishment of the President’s Cancer Panel. Nevertheless, there remain significant opportunities to make improvements across the cancer spectrum, perhaps none more pressing...
FDA Approves Neoadjuvant Nivolumab and Platinum Doublet Chemotherapy for Early-Stage NSCLC
On March 4, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo) in combination with platinum-doublet chemotherapy for adult patients with resectable non–small cell lung cancer (NSCLC) in the neoadjuvant setting. This represents the first FDA approval for neoadjuvant therapy for...
FDA Clinical Trial Guidances Share Biden Administration’s Goals for Advancing Development of Cancer Treatments
The U.S. Food and Drug Administration (FDA) has issued three final guidances to industry regarding cancer clinical trials that parallel the goals of President Biden’s recently announced effort to renew and build upon his 2016 Cancer Moonshot initiative. Both endeavors aim to facilitate continued...
FDA Approves Pacritinib for Adult Patients With Myelofibrosis and Thrombocytopenia
On February 28, the U.S. Food and Drug Administration (FDA) approved pacritinib (Vonjo) for the treatment of adults with intermediate- or high-risk primary or secondary (post–polycythemia vera or post–essential thrombocythemia) myelofibrosis with a platelet count below 50 × 109/L. Pacritinib is a...
FDA Approves Ciltacabtagene Autoleucel for Relapsed or Refractory Multiple Myeloma
On February 28, the U.S. Food and Drug Administration (FDA) approved ciltacabtagene autoleucel (Carvykti) for the treatment of adults with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 ...
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...
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...
