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Your search for Richard Pazdur, MD,Richard Pazdur, MD matches 250 pages

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breast cancer

FDA Approves Pertuzumab for HER2-positive Metastatic Breast Cancer

The FDA has approved pertuzumab (Perjeta), a new anti-HER2 therapy, to treat patients with HER2-positive late-stage breast cancer. Intended for patients who have not received prior treatment for metastatic breast cancer with an anti-HER2 therapy or chemotherapy, pertuzumab is combined with...

issues in oncology

Symposium Focuses on Policy Issues in Personalized Cancer Care

“What is the biggest barrier to progress in personalized medicine?” asked moderator Anna Barker, PhD, leading a panel discussion at a recent meeting convened by the Washington-based advocacy group, the Personalized Medicine Coalition, with the American Association for Cancer Research and Feinstein...

multiple myeloma

FDA Grants Accelerated Approval to Carfilzomib for Multiple Myeloma

Onyx Pharmaceuticals announced that the FDA has granted accelerated approval to carfilzomib (Kyprolis) for the treatment of patients with multiple myeloma who have received at least two prior therapies, including treatment with bortezomib (Velcade) and an immunomodulatory therapy, and have...

FDA Approves New Treatment for Severe Neutropenia

The FDA recently approved Sicor Biotech’s tbo-filgrastim (Neutroval) to reduce the time certain patients receiving chemotherapy experience severe neutropenia. The new drug is a short-acting recombinant granulocyte colony-stimulating factor (G-CSF) agent. It is marketed as Tevagrastim in Europe,...

colorectal cancer

Regorafenib Approved for Advanced Colorectal Cancer

The FDA recently approved regorafenib (Stivarga) to treat patients with metastatic colorectal cancer that has progressed after treatment. Regorafenib is a multikinase inhibitor that blocks several enzymes that promote cancer growth. The drug was reviewed under the FDA’s priority review program that ...

FDA Approves Omacetaxine for Chronic Myeloid Leukemia

The FDA has approved omacetaxine mepesuccinate (Synribo) to treat adults with chronic myelogenous leukemia (CML) whose cancer has progressed after treatment with at least two tyrosine kinase inhibitors. Omacetaxine is injected subcutaneously twice daily for 14 consecutive days over a 28-day cycle...

leukemia

FDA Approves Ponatinib to Treat CML and Philadelphia Chromosome–positive ALL

In December, the FDA granted accelerated approval to ponatinib (Iclusig) for the treatment of adult patients with chronic-, accelerated-, or blast-phase chronic myeloid leukemia (CML) that is resistant or intolerant to prior tyrosine kinase inhibitor therapy or Philadelphia chromosome–positive...

leukemia

Imatinib Receives New Indication for Children with Acute Lymphoblastic Leukemia 

The FDA approved a new use of imatinib (Gleevec) to treat children newly diagnosed with Philadelphia chromosome–positive acute lymphoblastic leukemia (ALL). ALL is the most common type of pediatric cancer, affecting approximately 2,900 children annually, and progresses quickly if untreated....

multiple myeloma

FDA Approves Pomalidomide for Advanced Multiple Myeloma

The FDA approved pomalidomide (Pomalyst) an oral immunomodulatory agent, to treat patients with multiple myeloma whose disease progressed after being treated with other cancer drugs. Pomalidomide is intended for patients who have received at least two prior therapies, including lenalidomide...

solid tumors

FDA Approves Regorafenib for Advanced Gastrointestinal Stromal Tumors

The FDA has expanded the approved use of regorafenib (Stivarga) to treat patients with metastatic or unresectable gastrointestinal stromal tumors (GIST) that no longer respond to treatment with imatinib (Gleevec) or sunitinib (Sutent). Regorafenib, a multikinase inhibitor, blocks several enzymes...

breast cancer

T-DM1 for HER2-positive Metastatic Breast Cancer Receives FDA Approval

The FDA approved the antibodydrug conjugate ado-trastuzumab emtansine (Kadcyla), referred to as T-DM1 during clinical research, for patients with HER2-positive, metastatic breast cancer who were previously treated with trastuzumab (Herceptin) and taxane chemotherapy. Ado-trastuzumab emtansine was...

Leading Investigators Honored for Outstanding Contributions to the Field of Oncology

Each year through its Special Awards Program, ASCO recognizes researchers, patient advocates, and leaders of the global oncology community who, through their work, have made significant contributions to enhancing cancer care. These recipients of ASCO’s highest, most prestigious awards collectively...

skin cancer

FDA Approves Two Drugs, Companion Diagnostic Test for Advanced Skin Cancer

The U.S. Food and Drug Administration (FDA) recently approved two new drugs, dabrafenib (Tafinlar) and trametinib (Mekinist), for patients with advanced or unresectable melanoma. Dabrafenib, a BRAF inhibitor, is approved to treat patients with melanoma whose tumors express the BRAF V600E gene...

solid tumors

FDA Approves Denosumab to Treat Giant Cell Tumor of the Bone

The U.S. Food and Drug Administration (FDA) has expanded the approved use of denosumab (Xgeva) to treat adults and some adolescents with giant cell tumor of the bone, a rare and usually noncancerous tumor. Denosumab, which was granted orphan product designation, was reviewed under the FDA’s...

leukemia

FDA on CLL Drug Approval and Expanded Access

The ASCO Post article, “Ibrutinib CLL Trial: Where is the Equipoise?” published in May 2013, inaccurately conveyed that the Food and Drug Administration (FDA) requires an improvement in overall survival for chronic lymphocytic leukemia (CLL) drug approval and opposes allowing crossover in the...

pancreatic cancer

FDA Approves Nab-Paclitaxel for Late-Stage Pancreatic Cancer

The U.S. Food and Drug Administration (FDA) has expanded the approved uses of paclitaxel protein-bound particles for injectable suspension, albumin-bound (nab-paclitaxel, Abraxane) to treat patients with late-stage pancreatic cancer. “Patients with pancreatic cancer are often diagnosed after the...

issues in oncology
legislation

A Look Ahead: How the FDA Is Adapting in the Era of Precision Medicine  

Dubbed “Cancer Czar” by the media, Richard Pazdur, MD, Director of the U.S. Food and Drug Administration (FDA) Office of Hematology and Oncology Products, said he has the “best job in oncology, with a unique vantage point in cancer drug development.” An oncologist for more than 30 years—including...

leukemia

FDA Approves Obinutuzumab for Chronic Lymphocytic Leukemia 

The U.S. Food and Drug Administration (FDA) has approved obinutuzumab (Gazyva) for use in combination with chlorambucil (Leukeran) to treat patients with previously untreated chronic lymphocytic leukemia (CLL). Obinutuzumab is the first drug with Breakthrough Therapy designation to receive FDA...

lymphoma

FDA Approves Ibrutinib for Mantle Cell Lymphoma

The U.S. Food and Drug Administration has approved ibrutinib (Imbruvica) to treat patients with mantle cell lymphoma, a rare and aggressive form of non-Hodgkin lymphoma representing about 6% of all non-Hodgkin lymphoma cases in the United States. By the time mantle cell lymphoma is diagnosed, it...

health-care policy

National Cancer Policy Summit: Setting Priorities for the Next 3 Years

Welcome to the meeting we hold every 3 years to choose our next projects,” said John Mendelsohn, MD, Chair of the National Cancer Policy Forum and Director of the Khalifa Institute for Personalized Cancer Therapy at The University of Texas M.D. Anderson Cancer Center, Houston. “We have here a...

thyroid cancer

FDA Approves Sorafenib to Treat Late-Stage Differentiated Thyroid Cancer

The U.S. Food and Drug Administration recently expanded the approved uses of sorafenib (Nexavar) to treat late-stage differentiated thyroid cancer. The new indication is for patients with locally recurrent or metastatic, progressive differentiated thyroid cancer that no longer responds to...

issues in oncology

Oncology Drug Dosing: Can an Optimal Dose Be Fine-Tuned for Each Patient?

ASCO Chief Medical Officer Richard L. Schilsky, MD, and other oncology drug experts presented a panel on drug dosing at a recent meeting, cosponsored by the Friends of Cancer Research and the Brookings Institution, in Washington, DC.1 The presentations made it clear that issues surrounding drug...

lung cancer

Molecularly Targeted Therapy for Lung Cancer

INSIDE THE BLACK BOX is an occasional column offering insight into the FDA and its policies and procedures. This installment addresses a changing paradigm in the treatment of lung cancer, exemplified by concurrent approval of a companion diagnostic with each of several new targeted agents or new...

leukemia

FDA Approves Ibrutinib for the Treatment of Chronic Lymphocytic Leukemia

The U.S. Food and Drug Administration (FDA) has expanded the approved use of ibrutinib (Imbruvica) for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one previous therapy. Ibrutinib, an oral Bruton’s tyrosine kinase inhibitor, was previously granted...

gastrointestinal cancer

FDA Approves Ramucirumab for Stomach Cancer

The U.S. Food and Drug Administration (FDA) has approved ramucirumab (Cyramza) to treat patients with advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with disease progression on or after prior treatment with fluoropyrimidine- or platinum-containing chemotherapy....

Enthusiasm and Vision Guide the Head of FDA’s Oncology Office

In  2005, Richard Pazdur, MD, was named the FDA’s Director of the Office of Hematology and Oncology Products. By any measure, being arbiter of the nation’s oncology drug pipeline is a daunting prospect, but Dr. Pazdur sees it as an opportunity to encourage his talented staff to work for the greater ...

hematologic malignancies

FDA Approval of Siltuximab for Multicentric Castleman’s Disease

INSIDE THE BLACK BOX is an occasional column providing insight into the FDA and its policies and procedures. In this installment, FDA hematologist/oncologist Albert Deisseroth, MD, PhD, discusses the recent approval of siltuximab for patients with multicentric Castleman’s disease who are human...

lymphoma

FDA Approves Belinostat for Relapsed or Refractory Peripheral T-Cell Lymphoma

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to belinostat (Beleodaq), a histone deacetylase inhibitor, for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma, a rare and fast-growing type of non-Hodgkin lymphoma (NHL). “This is the...

lung cancer

FDA Approval of Ceritinib for the Treatment of ALK-Positive Non–Small Cell Lung Cancer

INSIDE THE BLACK BOX is an occasional column providing insight into the U.S. Food and Drug Administration (FDA) and its policies and procedures. In this installment, FDA oncologists Sean Khozin, MD, MPH, and Dikran Kazandjian, MD, discuss anaplastic lymphoma kinase (ALK)-positive non–small cell...

leukemia
lymphoma

Recent FDA Drug Approvals Foster Growing Treatment Armamentarium for Chronic Lymphocytic Leukemia and Rare B-Cell Lymphomas

Recent approvals announced by the U.S. Food and Drug Administration (FDA) have led to increased treatment options for managing several difficult-to-treat hematologic B-cell cancers. The newly approved drugs and/or their indications include the oral PI3K delta inhibitor idelalisib (Zydelig) for the...

gynecologic cancers

FDA Approves Bevacizumab for Aggressive and Late-Stage Cervical Cancer

The U.S. Food and Drug Administration (FDA) has approved the antiangiogenic agent bevacizumab (Avastin) for the treatment of persistent, recurrent, or metastatic cervical cancer. The new indication is approved for use in combination with paclitaxel and cisplatin or paclitaxel and topotecan. The FDA ...

issues in oncology

Patient-Reported Outcomes in Hematology and Oncology Product Development

INSIDE THE BLACK BOX is an occasional column providing insight into the U.S. Food and Drug Administration (FDA) and its policies and procedures. In this installment, Virginia Kwitkowski, MS, RN, ACNP-BC, and Elektra Papadopoulos, MD, MPH, discuss FDA’s current approach to the review of study...

skin cancer

FDA Approves Pembrolizumab for Advanced Melanoma

The U.S. Food and Drug Administration (FDA) today granted accelerated approval to the anti–PD-1 antibody pembrolizumab (Keytruda) for the treatment of patients with advanced or unresectable melanoma who are no longer responding to other drugs. Pembrolizumab is intended for use following treatment...

leukemia

FDA Approves Blinatumomab to Treat Rare Form of Acute Lymphoblastic Leukemia

The U.S. Food and Drug Administration (FDA) today granted accelerated approval to blinatumomab (Blincyto) for the treatment of patients with Philadelphia chromosome–negative, relapsed or refractory precursor B-cell acute lymphoblastic leukemia (B-cell ALL). Blinatumomab is a bispecific...

gynecologic cancers

FDA Approves Olaparib to Treat BRCA-Mutated Advanced Ovarian Cancer

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to olaparib (Lynparza) for women with advanced ovarian cancer with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer, as detected by an FDA-approved test, who have been treated with three...

skin cancer

FDA Approves Nivolumab for Advanced Melanoma

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to nivolumab (Opdivo) for patients with unresectable or metastatic melanoma who no longer respond to other drugs. Nivolumab, a programmed cell death protein 1 (PD-1) inhibitor, is intended for patients who have been...

Friends of Cancer Research Holds Annual Conference on Clinical Cancer Research

Friends of Cancer Research, in conjunction with the Engelberg Center for Health Care Reform at Brookings, recently held the seventh annual Conference on Clinical Cancer Research in Washington, DC. The panels that comprised the daylong meeting discussed a future that has already begun. The most...

lymphoma

FDA Expands Approved Use of Ibrutinib for Waldenström’s Macroglobulinemia

The U.S. Food and Drug Administration (FDA) today expanded the approved use of ibrutinib (Imbruvica) for patients with Waldenström’s macroglobulinemia, a rare, indolent type of B-cell lymphoma. Ibrutinib is the first therapy indicated specifically for Waldenström’s macroglobulinemia and previously...

issues in oncology

Pharmacokinetics and Exposure Response in Drug Development

INSIDE THE BLACK BOX is an occasional column offering insight into the U.S. Food and Drug Administration (FDA) and its policies and procedures. In this installment, former clinical pharmacology team leader Julie Bullock, PharmD, and current team leader Nitin Mehrotra, PhD, discuss how...

multiple myeloma

FDA Approves Panobinostat Combination for the Treatment of Multiple Myeloma

The U.S. Food and Drug Administration (FDA) has approved panobinostat (Farydak) in combination with bortezomib (Velcade) and dexamethasone for the treatment of patients with multiple myeloma. Panobinostat is the first histone deacetylase (HDAC) inhibitor approved to treat multiple myeloma. It is...

thyroid cancer

FDA Approves Lenvatinib for Progressive Radioiodine-Refractory Differentiated Thyroid Cancer

The U.S. Food and Drug Administration (FDA) has granted approval to lenvatinib (Lenvima) to treat patients with progressive, differentiated thyroid cancer whose disease progressed despite receiving radioactive iodine therapy. Lenvatinib is a tyrosine kinase inhibitor that binds to multiple sites...

breast cancer

FDA Approves Palbociclib in Combination With Letrozole for Advanced Breast Cancer

The U.S. Food and Drug Administration has granted accelerated approval to palbociclib (Ibrance) in combination with letrozole for the treatment of postmenopausal women with estrogen receptor–positive, HER2-negative metastatic breast cancer who have not yet received an endocrine-based therapy....

cns cancers

Dinutuximab Combination Approved for Pediatric High-Risk Neuroblastoma

The U.S. Food and Drug Administration (FDA) has approved dinutuximab (Unituxin), a monoclonal antibody targeting glycolipid GD2,  as part of first-line therapy for pediatric patients with high-risk neuroblastoma. A chimeric monoclonal antibody that binds to the surface of neuroblastoma cells,...

issues in oncology

Development and Approval of Biosimilar Products

INSIDE THE BLACK BOX is an occasional column providing insight into the U.S. Food and Drug Administration (FDA) and its policies and procedures. In this installment, Leah Christl, PhD, and Albert Deisseroth, MD, PhD, answer questions about biosimilar products. Dr. Christl is the Associate Director...

The ASCO Post Replies

Nivolumab (Opdivo) was approved by the U.S. Food and Drug Administration (FDA) for the treatment of lung cancer on March 4, 2015, before clinical data from the pivotal trials (CheckMate 017 and CheckMate 063) were presented at a major oncology conference or published in a peer-reviewed journal....

Richard Pazdur, MD, and Anthony S. Fauci, MD, Included in Fortune’s List of the World’s 50 Greatest Leaders

Richard Pazdur, MD, Director of the Office of Oncology and Hematology Products at the U.S. Food and Drug Administration (FDA) was named one of the world’s 50 greatest leaders by Fortune Magazine. The list also included names such as Pope Francis, Apple CEO Tim Cook, Chief Justice of the United...

issues in oncology

Building a Better Federal Oncology Workforce

The process of delivering novel treatments for patients with cancer involves a multifaceted and long-term interaction between three distinct entities: clinical researchers, who conduct the trials which test treatments; drug developers, including the pharmaceutical industry, which takes cancer drugs ...

Richard Pazdur, MD, Receives AACR Public Service Award

Richard Pazdur, MD, was awarded the American Association of Cancer Research’s (AACR) Distinguished Public Service Award at the 2015 AACR Annual Meeting. The Association chose Dr. Pazdur for this award based on his “extraordinary, steadfast leadership in scientific and regulatory affairs” and his...

issues in oncology

FDA’s Pregnancy Category Labeling

INSIDE THE BLACK BOX is an occasional column providing insight into the U.S. Food and Drug Administration (FDA) and its policies and procedures. In this installment, FDA supervisory toxicologist Todd Palmby, PhD, and pharmacologist Eias Zahalka, PhD, MBA, discuss the approach taken in the Office of ...

lung cancer

ODAC Discussion ‘Constructive’ About Necitumumab for Squamous NSCLC

The U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) favored the approval of necitumumab in combination with gemcitabine and cisplatin for use in first-line treatment of patients with locally advanced or metastatic squamous non–small cell lung cancer (NSCLC). In...

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