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Showing 1 - 50FDA Launches Pilot Program to Help Reduce Risks Associated With Using Laboratory Developed Tests to Identify Cancer Biomarkers
The U.S. Food and Drug Administration (FDA) announced a new voluntary pilot program to help physicians select safe and effective cancer treatments, with guidance on in vitro companion diagnostic tests to determine which corresponding oncology drugs may provide the most benefit for their patients....
Narratives in Oncology Through the Years
Beginning in 2012, The ASCO Post introduced Narratives in Oncology, a special commemorative issue profiling several of the many leaders in the oncology community. Over the past years, many in the oncology community have been profiled in this commemorative issue. A complete list of individuals...
FDA Issues Draft Guidance Aimed at Improving Oncology Clinical Trials for Accelerated Approval
On March 24, the U.S. Food and Drug Administration (FDA) issued draft guidance, Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics, regarding clinical trial design considerations to support accelerated approval applications. The accelerated approval pathway is...
FDA Oncology Center of Excellence Seeks Applications for New Research Funding Opportunities
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,...
FDA Approves First Targeted Therapy for HER2-Low Breast Cancer
On August 5, 2022, the U.S. Food and Drug Administration (FDA) approved fam-trastuzumab deruxtecan-nxki (T-DXd, Enhertu), an intravenous infusion for the treatment of patients with unresectable or metastatic HER2-low breast cancer. This is the first approved therapy targeted to patients with the...
Narratives in Oncology Through the Years
Beginning in 2012, The ASCO Post introduced Narratives in Oncology, a special commemorative issue profiling several of the many leaders in the oncology community. Over the past years, many in the oncology community have been profiled in this commemorative issue. Here is a complete list of...
How to Get the Dose Right
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, Mirat Shah, MD, of the Office of Oncologic Diseases, Center for Drug Evaluation and Research, FDA; Atiqur...
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...
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...
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...
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,...
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 Encourages Inclusion of Patients With Incurable Cancers in Oncology Clinical Trials Regardless of Prior Therapies
On June 24, 2021, Richard Pazdur, MD, Director of the U.S. Food and Drug Administration’s Oncology Center of Excellence and Acting Director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, made the following statement: “Today, the FDA issued a draft...
Narratives in Oncology Through the Years
Beginning in 2012,The ASCO Post introduced Narratives in Oncology, a special commemorative issue profiling several of the many leaders in the oncology community. Over the past years, many in the oncology community have been profiled in this commemorative issue. A complete list of individuals...
FDA Approves Sotorasib for KRAS G12C–Mutated NSCLC
On May 28, the U.S. Food and Drug Administration (FDA) approved sotorasib (Lumakras) as the first treatment for adult patients with non–small cell lung cancer (NSCLC) whose tumors have a KRAS G12C genetic mutation and who have received at least one prior systemic therapy. This is the first approved ...
FDA ODAC Meeting Focuses on ‘Dangling’ Accelerated Approvals of Anti–PD-1/PD-L1 Antibodies
In a perspective in The New England Journal of Medicine, Julia A. Beaver, MD, and Richard Pazdur, MD, of the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE), discussed issues surrounding “dangling” accelerated approvals of anti–PD-1/PD-L1 antibodies—ie, approvals for...
‘Dangling’ Accelerated Approvals of Anti–PD-1/PD-L1 Antibodies to Be Discussed at FDA Oncologic Drugs Advisory Committee Meeting
In a Perspective article in The New England Journal of Medicine, Julia A. Beaver, MD, and Richard Pazdur, MD, of the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCD), discussed issues surrounding “dangling” accelerated approvals of anti–PD-1/PD-L1 antibodies—ie,...
FDA Oncologic Drugs Advisory Committee to Review Status of Six Indications Granted Accelerated Approval
Recently, the U.S. Food and Drug Administration (FDA) announced that the agency will hold a public meeting of the Oncologic Drugs Advisory Committee on April 27 to 29 to discuss six indications granted accelerated approval that have since reported results from confirmatory trials that have not...
FDA Approves First Oral Hormone Therapy for Treating Advanced Prostate Cancer
Today, the U.S. Food and Drug Administration (FDA) approved relugolix (Orgovyx) for the treatment of adult patients with advanced prostate cancer. “Today’s approval marks the first oral drug in this class and it may eliminate some patients’ need to visit the clinic for treatments that require...
Project Orbis: Partnering With International Regulatory Agencies to Bring Earlier Global Access to Novel Cancer Treatments
OCE Insights is an occasional department 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, Preeti Narayan, MD, a medical oncologist and clinical reviewer on the Breast and Gynecologic Disease Team,...
FDA and AACR Launch Project Livin’ Label
The American Association for Cancer Research (AACR) and the U.S. Food and Drug Administration (FDA) will collaborate on Project Livin’ Label, a new educational initiative that aims to foster broad understanding of specific oncology product labels and increase awareness of recent oncology drug FDA...
Committed to Excellence: Oncology Drug Development Marches on Amid a Pandemic
Instituted as part of the 21st Century Cures Act, the Oncology Center of Excellence (OCE) fosters a unified interaction between three U.S. Food and Drug Administration (FDA) centers: Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research, and Center for Devices and...
Richard Pazdur, MD, Awarded the Simon M. Shubitz Cancer Prize and Lectureship
For more than 4 decades, the University of Chicago Cancer Research Foundation’s Simon M. Shubitz Cancer Prize and Lectureship has honored an internationally renowned individual for his or her exceptional contributions to cancer research and clinical care. The recipient of this year’s award is...
Tumor Mutational Burden and the Future of Complex Biomarkers
The development of complex biomarkers such as tumor mutational burden (TMB) has enabled clinicians to identify patients more likely to respond to treatment of a variety of cancers, leading to more accurate diagnoses and improved outcomes. Differences in testing assays, however, have produced...
FDA Approves Combination of Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf for HER2-Positive Breast Cancer
On June 29, the U.S. Food and Drug Administration (FDA) approved a new fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase-zzxf (Phesgo) for subcutaneous injection in the following indications: Use in combination with chemotherapy as: Neoadjuvant treatment for patients with...
The ASCO Post and Narratives in Oncology Through the Years
THE ASCO POST is pleased to acknowledge its 10th anniversary. Our first issue was launched in June 2010 at the ASCO Annual Meeting. Beginning in 2012, The ASCO Post introduced Narratives in Oncology, a special commemorative issue profiling leaders in the oncology community. To nominate an...
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 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 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...
FDA Approves Isatuximab-irfc–Based Triplet Regimen for Patients With Relapsed or Refractory Multiple Myeloma
On March 2, the U.S. Food and Drug Administration (FDA) approved isatuximab-irfc (Sarclisa) in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor. ...
Update on Project Facilitate at the Oncology Center of Excellence
OCE Insights is an occasional department 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, Mitchell Chan, PharmD, BCPS, Regulatory Project Manager; Tamy Kim, PharmD, Associate Director of Regulatory ...
FDA Approves Tazemetostat for Epithelioid Sarcoma
On January 23, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tazemetostat (Tazverik) for adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection. “Epithelioid sarcoma accounts...
FDA Approves Avapritinib for the Treatment of PDGFRA-Mutated Gastrointestinal Stromal Tumor
On January 9, the U.S. Food and Drug Administration (FDA) approved avapritinib (Ayvakit) for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) that harbors platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation. This approval includes...
Highlights From the 2019 ASCO Research Community Forum Annual Meeting
Researchers from around the country joined together for learning and collaboration at the 2019 ASCO Research Community Forum (RCF) Annual Meeting in September. During the meeting, Aisha Peterson Johnson, MD, MPH, MBA, of the U.S. Food and Drug Administration (FDA) Office of Compliance, delivered a...
FDA Approves Enfortumab Vedotin-ejfv for Previously Treated Advanced Urothelial Cancer
On December 18, the U.S. Food and Drug Administration (FDA) granted accelerated approval to enfortumab vedotin-ejfv (Padcev) for adult patients with locally advanced or metastatic urothelial cancer who have previously received neoadjuvant or adjuvant treatment with a programmed cell death protein 1 ...
FDA Approves Voxelotor for Sickle Cell Disease
On November 25, the U.S. Food and Drug Administration (FDA) granted accelerated approval to voxelotor (Oxbryta) for adults and pediatric patients 12 years of age and older with sickle cell disease. “[Voxelotor] is an inhibitor of deoxygenated sickle hemoglobin polymerization, which is the central...
FDA Approves Voxelotor for Sickle Cell Disease
On November 25, the U.S. Food and Drug Administration (FDA) granted accelerated approval to voxelotor (Oxbryta) for adults and pediatric patients 12 years of age and older with sickle cell disease. “[Voxelotor] is an inhibitor of deoxygenated sickle hemoglobin polymerization, which is the central...
FDA Office of Hematology Oncology Products Reorganized, Renamed Office of Oncologic Diseases
As part of modernization plans approved in September 2019, the U.S. Food and Drug Administration (FDA) office responsible for reviewing applications for new and existing cancer therapies has reorganized and been renamed. The Center for Drug Evaluation and Research (CDER) Office of Hematology and...
Project Socrates: An Educational Bridge From the FDA to the Public
OCE Insights is an occasional department 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, Jennifer J. Gao, MD, Acting Associate Director of Education in the OCE, and Richard Pazdur, MD, Director of ...
FDA Approves Givosiran for Acute Hepatic Porphyria
On November 20, the U.S. Food and Drug Administration (FDA) approved givosiran (Givlaari) for adults with acute hepatic porphyria, a genetic disorder resulting in the buildup of toxic porphyrin molecules which are formed during the production of heme. “This buildup can cause acute attacks, known...
FDA Approves Acalabrutinib for CLL/SLL as Part of Project Orbis
On November 21, as part of Project Orbis—a collaboration with the Australian Therapeutic Goods Administration (TGA) and Health Canada—the U.S. Food and Drug Administration (FDA) granted supplemental approval to acalabrutinib (Calquence) for the treatment of adults with chronic lymphocytic leukemia...
FDA Grants Accelerated Approval to Zanubrutinib for Pretreated Mantle Cell Lymphoma
On November 14, the U.S. Food and Drug Administration (FDA) granted accelerated approval to zanubrutinib (Brukinsa) for adult patients with mantle cell lymphoma who have received at least one prior therapy. “Mantle cell lymphoma usually responds well to initial treatment, but eventually returns or ...
FDA Office of Hematology Oncology Products Reorganizes, Renamed Office of Oncologic Diseases
As part of modernization plans approved in September 2019, the U.S. Food and Drug Administration (FDA) office responsible for reviewing applications for new and existing cancer therapies has reorganized and been renamed. The Center for Drug Evaluation and Research (CDER) Office of Hematology and...
FDA Grants Approval to Lenvatinib/Pembrolizumab in Advanced Endometrial Cancer, Announces Project Orbis
The U.S. Food and Drug Administration (FDA) has announced Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE). Project Orbis provides a framework for concurrent submission and review of oncology drugs among its international partners. Under this project, the FDA, the...
FDA Approves Entrectinib for NTRK-Fusion Cancers, ROS1-Positive NSCLC
On August 15, the U.S. Food and Drug Administration (FDA) granted accelerated approval to entrectinib (Rozlytrek) for adult and adolescent patients whose cancers have an NTRK (neurotrophic tyrosine receptor kinase) genetic fusion and for whom there are no effective treatments. Entrectinib was also...
FDA Approves Fedratinib for Treatment of Myelofibrosis
On August 16, the U.S. Food and Drug Administration (FDA) approved the Janus kinase 2 (JAK2) inhibitor fedratinib (Inrebic) for the treatment of adults with intermediate-2 or high-risk primary or secondary (postpolycythemia vera or postessential thrombocythemia) myelofibrosis. “Prior to [this...
FDA Issues Draft Guidance Encouraging Inclusion of Male Patients in Breast Cancer Clinical Trials
A draft guidance issued by the U.S. Food Drug Administration (FDA) on August 26 includes draft recommendations for the inclusion of male patients in breast cancer clinical trials. Historically, males either have not been included in clinical trials for drugs to treat breast cancer, or inclusion of...
Register for ASCO’s Research Community Forum 2019 Annual Meeting
Registration is open for the ASCO Research Community Forum (RCF) 2019 Annual Meeting. The ASCO RCF Annual Meeting brings together physician-investigators and research staff from across the country for 2 days of learning and collaboration. The meeting offers colleagues from a variety of research...
FDA Approves Pexidartinib for Tenosynovial Giant Cell Tumor
ON AUGUST 2, the U.S. Food and Drug Administration (FDA) granted approval to pexidartinib (Turalio) capsules for the treatment of adult patients with symptomatic tenosynovial giant cell tumor associated with severe morbidity or functional limitations and not responsive to improvement with surgery. ...
FDA Approves Fedratinib for Myelofibrosis
Today, the U.S. Food and Drug Administration (FDA) approved fedratinib (Inrebic) for adults with intermediate-2 or high-risk primary or secondary (postpolycythemia vera or postessential thrombocythemia) myelofibrosis. “Prior to today, there was one FDA-approved drug to treat patients with...
