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Showing 201 - 250The 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...
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...
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 ...
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...
FDA Approves New Oral Medication for the Treatment of Refractory Metastatic Colorectal Cancer
The U.S. Food and Drug Administration (FDA) has approved trifluridine/tipiracil (Lonsurf) for patients with metastatic colorectal cancer who have been previously treated with chemotherapy and biologic therapy and are no longer responding to treatment. Mechanism of Action The new oral agent is a...
National Coalition for Cancer Survivorship Honors Richard Pazdur, MD, and Ellen Goodman
On October 21 in Washington, DC, the National Coalition for Cancer Survivorship (NCCS) hosted a reception to honor Richard Pazdur, MD, and Ellen Goodman. NCCS Chief Executive Officer, Shelly Fuld Nasso, welcomed attendees to the special awards reception. NCCS Public Service Leadership Award The...
FDA Approves Trabectedin for Advanced Liposarcoma and Leiomyosarcoma
The U.S. Food and Drug Administration has approved the novel chemotherapy drug trabectedin (Yondelis) for the treatment of specific soft-tissue sarcomas—liposarcoma and leiomyosarcoma—that are unresectable or metastatic. Trabectedin is a novel marine antineoplastic alkaloid with a unique mechanism ...
Daratumumab Approved in Multiple Myeloma
The U.S. Food and Drug Administration has granted accelerated approval for daratumumab (Darzalex) to treat patients with multiple myeloma who have received at least three prior treatments, including a proteasome inhibitor and an immunomodulatory agent, or who are double-refractory to a proteasome...
FDA Approves Cobimetinib in Combination With Vemurafenib for Metastatic Melanoma
On November 10, 2015, the U.S. Food and Drug Administration (FDA) approved the MEK inhibitor cobimetinib (Cotellic) in combination with the BRAF inhibitor vemurafenib (Zelboraf) to treat metastatic or unresectable melanoma in patients whose tumors express the BRAF V600E or V600K mutation. Approval...
Nationally Regarded Oncology Nurse Practitioner, Mary Pazdur, RN, MSN, Remembered by Friends and Colleagues
Oncology nurse practitioner Mary Pazdur, RN, MSN, spent her professional life bettering the clinical care and outcomes of cancer patients, culminating in her career at the National Cancer Institute (NCI), in the Laboratory of Tumor Immunology and Biology, working with patients on cancer vaccine...
Nivolumab Receives Two FDA Approvals in November
Nivolumab (Opdivo) is a monoclonal antibody that binds to the programmed cell death protein 1 (PD-1) receptor and blocks its interaction with its ligands PD-L1 and PD-L2, releasing PD-1 pathway–mediated inhibition of the immune response. Late last month, the U.S. Food and Drug Administration (FDA)...
FDA Approves Elotuzumab in Combination With Lenalidomide and Dexamethasone for Multiple Myeloma
The U.S. Food and Drug Administration (FDA) has granted approval for elotuzumab (Empliciti) in combination with two other therapies to treat patients with multiple myeloma who have received one to three prior medications. “We are continuing to learn about the ways the immune system interacts with...
Clinical Trial System Badly in Need of Overhaul, Say Panelists at Friends-Brookings Conference
Cancer clinical trials in three distinct phases, as they have been conducted for decades, are probably no longer the best way to bring a drug or biologic agent to market. This was the consensus of three panels at the 8th Annual Conference on Clinical Cancer Research convened by Friends of Cancer...
FDA Approves Alectinib for Advanced ALK-Positive NSCLC
The U.S. Food and Drug Administration (FDA) today granted accelerated approval to alectinib (Alecensa) for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive non–small cell lung cancer (NSCLC) who have had disease progression on or are intolerant to crizotinib (Xalkori). ...
FDA Approves Uridine Triacetate for Emergency Treatment of Fluorouracil or Capecitabine Overdose
The U.S. Food and Drug Administration (FDA) today approved uridine triacetate (Vistogard) for the emergency treatment of adults and children who receive an overdose of the cancer treatment fluorouracil (5-FU) or capecitabine, or who develop certain severe or life-threatening toxicities within...
FDA Approves Elotuzumab in Combination With Lenalidomide and Dexamethasone for Multiple Myeloma
The U.S. Food and Drug Administration (FDA) granted approval for elotuzumab (Empliciti) in combination with two other therapies to treat patients with multiple myeloma who have received one to three prior medications. “We are continuing to learn about the ways the immune system interacts...
FDA Approves Nivolumab to Treat Advanced Kidney Cancer
The U.S. Food and Drug Administration today approved nivolumab (Opdivo) to treat patients with metastatic renal cell carcinoma who have received a prior antiangiogenic therapy. Nivolumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2,...
FDA Approves Ixazomib in Combination With Lenalidomide and Dexamethasone for Multiple Myeloma
The U.S. Food and Drug Administration (FDA) granted approval for ixazomib (Ninlaro) in combination with two other agents to treat patients with multiple myeloma who have received at least one prior therapy. “As we learn more about the underlying biology of multiple myeloma, we are encouraged ...
FDA Approves Daratumumab for Patients With Previously Treated Multiple Myeloma
Today the U.S. Food and Drug Administration granted accelerated approval for daratumumab (Darzalex) to treat patients with multiple myeloma who have received at least three prior treatments, including a proteasome inhibitor and an immunomodulatory agent, or who are double-refractory to a proteasome ...
FDA Approves Osimertinib for EGFR T790M Mutation–Positive Non–Small Cell Lung Cancer After Progression on Prior EGFR-Blocking Therapy
The U.S. Food and Drug Administration (FDA) granted accelerated approval for an oral medication to treat patients with advanced non–small cell lung cancer (NSCLC). Osimertinib (Tagrisso) is now approved for patients whose tumors have a specific epidermal growth factor receptor (EGFR) mutation ...
FDA Approves Cobimetinib in Combination With Vemurafenib for Advanced Melanoma
The U.S. Food and Drug Administration (FDA) approved cobimetinib (Cotellic) to be used in combination with vemurafenib (Zelboraf) to treat metastatic or unresectable melanoma, with the BRAF V600E or V600K mutation. “As we continue to advance our knowledge of tumor biology, we have...
FDA Approves Adjuvant Ipilimumab to Reduce the Risk of Melanoma Returning After Surgery
The U.S. Food and Drug Administration has expanded the approved use of ipilimumab (Yervoy) to include a new use as adjuvant therapy for patients who have cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm and have undergone complete resection, including total...
National Coalition for Cancer Survivorship Honors Richard Pazdur, MD, and Ellen Goodman
On October 21 in Washington, DC, the National Coalition for Cancer Survivorship (NCCS) hosted a reception to honor Richard Pazdur, MD, and Ellen Goodman. Special guest Robert M. Califf, MD, Deputy Commissioner for Medical Products and Tobacco at the U.S. Food and Drug Administration (FDA),...
FDA Approves Trabectedin for Advanced Liposarcoma and Leiomyosarcoma
The U.S. Food and Drug Administration today approved the chemotherapy drug trabectedin (Yondelis) for the treatment of specific soft-tissue sarcomas—liposarcoma and leiomyosarcoma—that are unresectable or metastatic. This treatment is approved for patients who previously received...
FDA Approves Use of Nivolumab in Advanced Nonsquamous Lung Cancer
The U.S. Food and Drug Administration (FDA) today approved nivolumab (Opdivo) to treat patients with metastatic nonsquamous non–small cell lung cancer (NSCLC) whose disease progressed during or after platinum-based chemotherapy. Nivolumab is a monoclonal antibody that that blocks the...
FDA Grants Accelerated Approval to Pembrolizumab for Advanced NSCLC
On October 2, 2015, the U.S. Food and Drug Administration (FDA) granted accelerated approval for pembrolizumab (Keytruda) to treat patients with metastatic non–small cell lung cancer (NSCLC) whose disease has progressed after other treatments and with tumors that express programmed cell...
FDA Approves New Oral Medication for the Treatment of Refractory Metastatic Colorectal Cancer
The U.S. Food and Drug Administration today approved trifluridine/tipiracil (Lonsurf) for patients with metastatic colorectal cancer who have been previously treated with chemotherapy and biologic therapy and are no longer responding to treatment. The new agent is an oral combination of...
FDA Approves Dinutuximab Combination for Pediatric Patients With High-Risk Neuroblastoma
The U.S. Food and Drug Administration has approved dinutuximab (Unituxin) as part of first-line therapy for pediatric patients with high-risk neuroblastoma. Dinutuximab, a chimeric monoclonal antibody that binds to the surface of neuroblastoma cells, is being approved for use as part of a...
FDA Approves Panobinostat Combination for the Treatment of Multiple Myeloma
The U.S. Food and Drug Administration (FDA) today 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...
FDA Approves Lenvatinib for Progressive Radioiodine-Refractory Differentiated Thyroid Cancer
The U.S. Food and Drug Administration (FDA) today 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...
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. ...
FDA Approves New Indication for Ibrutinib in 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...
FDA Approves Nivolumab for Advanced Melanoma
The U.S. Food and Drug Administration (FDA) today granted accelerated approval to nivolumab (Opdivo) for patients with unresectable or metastatic melanoma who no longer respond to other drugs. Nivolumab, a PD-1 inhibitor, is intended for patients who have been previously treated with ipilimumab...
FDA Approves Olaparib to Treat BRCA-Mutated Advanced Ovarian Cancer
The U.S. Food and Drug Administration (FDA) today 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 ...
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...
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...
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 ...
FDA Expands Approved Use of Ibrutinib for Chronic Lymphocytic Leukemia
The U.S. Food and Drug Administration (FDA) today expanded the approved use of ibrutinib (Imbruvica) to treat patients with chronic lymphocytic leukemia (CLL) who carry deletions of the short arm of chromosome 17, which are associated with poor responses to standard treatment for CLL. Ibrutinib...
FDA Approves Idelalisib for Three Types of Blood Cancers
The U.S. Food and Drug Administration (FDA) has approved idelalisib (Zydelig) for the treatment of patients with three types of blood cancers. Idelalisib is being granted traditional approval to treat patients with relapsed chronic lymphocytic leukemia (CLL). Used in combination with rituximab...
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...
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....
FDA Approves Ibrutinib for the Treatment of Chronic Lymphocytic Leukemia
The U.S. Food and Drug Administration (FDA) today 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...
FDA Approves Sorafenib to Treat Late-Stage Differentiated Thyroid Cancer
The U.S. Food and Drug Administration today 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 radioactive...
FDA Approves Ibrutinib for Mantle Cell Lymphoma
The U.S. Food and Drug Administration today approved ibrutinib (Imbruvica) for the treatment of patients with mantle cell lymphoma, an aggressive B-cell lymphoma that represents about 6% of all non-Hodgkin lymphoma cases in the United States. The drug, a Bruton’s tyrosine kinase inhibitor, is ...
FDA Approves Obinutuzumab for Chronic Lymphocytic Leukemia
The U.S. Food and Drug Administration (FDA) today 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...
FDA Approves Neoadjuvant Pertuzumab for Early-Stage Breast Cancer
The U.S. Food and Drug Administration (FDA) today granted accelerated approval to pertuzumab (Perjeta) in combination with trastuzumab (Herceptin) and docetaxel for patients with early-stage breast cancer in the neoadjuvant setting. Pertuzumab is the first FDA-approved drug for the neoadjuvant...
FDA Approves Nab-Paclitaxel for Late-Stage Pancreatic Cancer
The U.S. Food and Drug Administration (FDA) today 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...
FDA Approves Afatinib for EGFR-mutant Late-stage Non–Small Cell Lung Cancer
The U.S. Food and Drug Administration (FDA) today approved the tyrosine kinase inhibitor afatinib (Gilotrif) for the first-line treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors express epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21...
