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Showing 51 - 100FDA 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...
FDA Approves Entrectinib for NTRK-Fusion Cancers, ROS1-Positive NSCLC
Today, 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 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 (TGCT) associated with severe morbidity or functional limitations and not responsive to improvement with...
Director of the FDA’s Oncology Center of Excellence Discusses Expanded Access, Accelerated Drug Approvals in Latest ASCO in Action Podcast
THE DIRECTOR OF the U.S. Food and Drug Administration’s (FDA) Oncology Center of Excellence (OCE), Richard Pazdur, MD, joins ASCO Chief Executive Officer Clifford A. Hudis, MD, FACP, FASCO, in the latest ASCO in Action Podcast to discuss the FDA’s new program to make it easier for physicians to...
FDA Grants Accelerated Approval to Selinexor in Combination With Dexamethasone in Pentarefractory Multiple Myeloma
On July 3, the U.S. Food and Drug Administration (FDA) granted accelerated approval to selinexor (Xpovio) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two ...
FDA Grants Accelerated Approval to Selinexor in Combination With Dexamethasone in Pentarefractory Multiple Myeloma
Today, the U.S. Food and Drug Administration (FDA) granted accelerated approval to selinexor (Xpovio) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two...
Project Facilitate: FDA’s Plan to Ease Expanded Access to Novel Therapies
The U.S. Food and Drug Administration (FDA) plans to provide oncologists with greater help in acquiring expanded access to investigational therapies. Deemed Project Facilitate, the pilot program was announced at a press briefing during the 2019 ASCO Annual Meeting. Project Facilitate is essentially ...
Register Early for ASCO’s Research Community Forum 2019 Annual Meeting
EARLY REGISTRATION is now 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...
FDA Announces Project Facilitate to Access Investigational Therapies for Patients With Cancer
The Oncology Center of Excellence of the U.S. Food and Drug Administration (FDA) recently announced a new pilot program to assist oncology health-care professionals in requesting access to unapproved therapies for patients with cancer. A new call center designated Project Facilitate will be a...
Richard Pazdur, MD, on the Launch of Project Facilitate
Richard Pazdur, MD, Director of the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence and Acting Director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, discusses the launch of Project Facilitate, a new pilot program to...
FDA Announces Project Facilitate
Today, the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence announced a new pilot program to assist oncology health-care professionals in requesting access to unapproved therapies for patients with cancer. A new call center designated Project Facilitate will be a single point...
FDA Approves Alpelisib in Combination With Fulvestrant for PIK3CA-Mutated, Hormone Receptor–Positive Advanced Breast Cancer
On May 24, the U.S. Food and Drug Administration (FDA) approved alpelisib (Piqray) tablets to be used in combination with the FDA-approved endocrine therapy fulvestrant to treat postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2...
FDA Approves Dalteparin Sodium for VTE in Pediatric Patients
On May 16, 2019, the U.S. Food and Drug Administration (FDA) approved dalteparin sodium (Fragmin) to reduce the recurrence of symptomatic venous thromboembolism (VTE) in pediatric patients 1 month of age and older. This is the first FDA-approved therapy to treat VTE in pediatric patients....
FDA Expands Palbociclib Indication in HR-Positive, HER2-Negative Breast Cancer to Include Male Patients
Today, the U.S. Food and Drug Administration (FDA) extended the indication of palbociclib (Ibrance) capsules in combination with specific endocrine therapies for hormone receptor (HR)–positive, HER2-negative advanced or metastatic breast cancer to include male patients. “Today, we are...
FDA Approves Caplacizumab-yhdp for Acquired Thrombotic Thrombocytopenic Purpura
ON FEBRUARY 6, 2019, the U.S. Food and Drug AdministrationFDA approved caplacizumab-yhdp (Cablivi) injection, in combination with plasma exchange and immunosuppressive therapy, for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP). “Patients with aTTP endure...
FDA Approves Caplacizumab-yhdp for Acquired Thrombotic Thrombocytopenic Purpura
Today, the U.S. Food and Drug Administration approved caplacizumab-yhdp (Cablivi) injection, the first therapy specifically indicated, in combination with plasma exchange and immunosuppressive therapy, for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), a...
FDA Approves Tagraxofusp-ezrs for Blastic Plasmacytoid Dendritic Cell Neoplasm
On December 21, the U.S. Food and Drug Administration (FDA) approved tagraxofusp-erzs (Elzonris) infusion for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients aged 2 years and older. “Prior to [this] approval, there had been no...
FDA Expands Approved Use of Brentuximab Vedotin in Some Types of PTCL
ON NOVEMBER 16, 2018, the U.S. Food and Drug Administration (FDA) expanded the approved use of brentuximab vedotin (Adcetris) injection in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma (PTCL)—adults with previously untreated systemic anaplastic...
FDA Approves Glasdegib for Patients With Newly Diagnosed AML Who Cannot Undergo Intensive Chemotherapy
Today, the U.S. Food and Drug Administration (FDA) approved glasdegib (Daurismo) tablets to be used in combination with low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults who are 75 years of age or older or with comorbidities that may preclude the use of ...
FDA Expands Approved Use of Brentuximab Vedotin in Some Types of PTCL
Today, the U.S. Food and Drug Administration (FDA) expanded the approved use of brentuximab vedotin (Adcetris) injection in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma (PTCL)—adults with previously untreated systemic anaplastic large cell...
FDA Approves Cemiplimab-rwlc for Metastatic Cutaneous Squamous Cell Carcinoma
On September 28, the U.S. Food and Drug Administration (FDA) approved cemiplimab-rwlc (Libtayo) injection for intravenous use for the treatment of patients with metastatic cutaneous squamous cell carcinoma (SCC) or locally advanced cutaneous SCC who are not candidates for curative surgery or...
FDA Approves Moxetumomab Pasudotox-tdfk for the Treatment of Hairy Cell Leukemia
ON SEPTEMBER 13, 2018, the U.S. Food and Drug Administration (FDA) approved moxetumomab pasudotox-tdfk (Lumoxiti) injection for intravenous use for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who have received at least two prior systemic therapies,...
FDA Approves Moxetumomab Pasudotox-tdfk for the Treatment of Hairy Cell Leukemia
The U.S. Food and Drug Administration (FDA) today approved moxetumomab pasudotox-tdfk (Lumoxiti) injection for intravenous use for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who have received at least two prior systemic therapies, including treatment with...
FDA Approves Mogamulizumab-kpkc for Two Rare Types of Non-Hodgkin Lymphoma
On August 8, the U.S. Food and Drug Administration approved mogamulizumab-kpkc (Poteligeo) injection for intravenous use in the treatment of adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy. This approval provides a new...
FDA Approves First Treatment for Rare Adrenal Tumors
On July 30, 2018, the U.S. Food and Drug Administration (FDA) approved iobenguane I 131 injection (Azedra) for intravenous use in the treatment of adults and adolescents aged 12 and older with unresectable pheochromocytoma or paraganglioma that have spread beyond the original tumor site and require ...
FDA Approves Mogamulizumab-kpkc for Two Rare Types of Non-Hodgkin Lymphoma
Today, the U.S. Food and Drug Administration approved mogamulizumab-kpkc (Poteligeo) injection for intravenous use for the treatment of adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy. This approval provides a new...
FDA Approves Iobenguane I-131 for Rare Adrenal Gland Tumors
On July 30, the U.S. Food and Drug Administration (FDA) approved iobenguane I-131 (Azedra) injection for adult and pediatric patients (12 years and older) with iobenguane scan–positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma (PPGL) who require systemic...
FDA Approves Ivosidenib for IDH1-Mutated AML
Today, the U.S. Food and Drug Administration (FDA) approved ivosidenib (Tibsovo) tablets for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. This is the first drug in its class (isocitrate dehydrogenase-1 [IDH1]...
FDA Approves Dabrafenib/Trametinib Combination for BRAF-Positive Anaplastic Thyroid Cancer
Today, the U.S. Food and Drug Administration approved dabrafenib (Tafinlar) and trametinib (Mekinist), administered together, for the treatment of unresectable, metastatic, BRAF V600E mutation–positive anaplastic thyroid cancer. Anaplastic thyroid cancer accounts for about 1% to 2% of all...
FDA Expands Approval of Blinatumomab for Certain Patients With B-Cell Precursor ALL
The U.S. Food and Drug Administration granted accelerated approval to blinatumomab (Blincyto) to treat adults and children with B-cell precursor acute lymphoblastic leukemia (ALL) who are in remission but still have minimal residual disease (MRD). In patients who have achieved remission after...
FDA Expands Approval of Brentuximab Vedotin for First-Line Treatment of Stage III or IV Classical Hodgkin Lymphoma in Combination With Chemotherapy
On March 20, the U.S. Food and Drug Administration (FDA) approved brentuximab vedotin (Adcetris) to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma in combination with chemotherapy. “Today’s approval represents an improvement in the initial...
FDA Expands Approval of Durvalumab to Reduce the Risk of NSCLC Progression
On February 16, the U.S. Food and Drug Administration (FDA) approved durvalumab (Imfinzi) for the treatment of patients with stage III unresectable non–small cell lung cancer (NSCLC) whose cancer has not progressed after treatment with chemoradiation. “This is the first treatment...
FDA Approves Apalutamide for Nonmetastatic, Castration-Resistant Prostate Cancer
The U.S. Food and Drug Administration (FDA) today approved apalutamide (Erleada) for the treatment of patients with prostate cancer that has not spread, but that continues to grow despite treatment with hormone therapy. This is the first FDA-approved treatment for nonmetastatic,...
FDA Approves Radiopharmaceutical for Rare Gastrointestinal Cancers
On January 26, 2018, the U.S. Food and Drug Administration (FDA) approved lutetium Lu-177 dotatate (Lutathera) for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The drug is indicated for adult patients with somatostatin receptor–positive GEP-NETs. GEP-NETs can be...
FDA Approves Lutetium Lu-177 Dotatate for Treatment of Gastroenteropancreatic Neuroendocrine Tumors
On January 26, the U.S. Food and Drug Administration (FDA) approved lutetium Lu-177 dotatate (Lutathera) for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This is the first time a radiopharmaceutical has been approved for the treatment of GEP-NETs. Lu-177 dotatate is...
FDA Approves Olaparib for Germline BRCA-Mutated Metastatic Breast Cancer
On January 12, 2018, the U.S. Food and Drug Administration (FDA) granted regular approval to olaparib (Lynparza), a poly ADP-ribose polymerase (PARP) inhibitor, for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated, HER2-negative metastatic breast cancer who...
FDA Approves Olaparib for Germline BRCA-Mutated Metastatic Breast Cancer
Today, the U.S. Food and Drug Administration (FDA) granted regular approval to olaparib (Lynparza), a poly ADP-ribose polymerase (PARP) inhibitor, for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated, HER2-negative metastatic breast cancer who have been...
FDA Updates Nilotinib Label With Information on Discontinuing Treatment in Certain Patients With Early-Phase CML After Sustained Response
On December 22, the U.S. Food and Drug Administration (FDA) updated the product label for nilotinib (Tasigna) to include information for providers about how to discontinue the drug in certain patients. Nilotinib, first approved by the FDA in 2007, is indicated for the treatment of patients with...
FDA Helps Streamline Approval Process for Supplemental Drug Indications
As researchers learn more about the natural history of cancers, as more drugs are effective for more types of the disease, and as the number and complexity of combination therapies increase, the more important it is that new drugs and permutations of old ones be available to patients. The U.S. Food ...
Mary Pazdur Award for Excellence in Advanced Practice in Oncology Announced
The inaugural Mary Pazdur Award for Excellence in Advanced Practice in Oncology was announced at the 2017 JADPRO Live at APSHO (Advanced Practitioner Society for Hematology and Oncology) conference. Jack Gentile, Chairman of Harborside, which sponsors the JADPRO Live at APSHO conference (and...
Shifting Landscape of Oncology Drug Development and Approvals
Future oncology drug development and approvals will be faster and more efficient as well as take the patient experience more into account, said Richard Pazdur, MD, Director of the Oncology Center of Excellence at the U.S. Food and Drug Administration (FDA). The Center was established as part of...
SABCS 40th Anniversary Award Lecture: Richard Pazdur, MD, on Cancer Drug Development
Richard Pazdur, MD, of the U.S. Food & Drug Administration’s Oncology Center of Excellence, discusses the rapid changes in evaluating and approving new and effective agents, incorporating the view of patients in the process, and modernizing clinical trial design with broader eligibility...
Mary Pazdur Award for Excellence in Advanced Practice in Oncology Announced at JADPRO Live
The inaugural Mary Pazdur Award for Excellence in Advanced Practice in Oncology was announced at the 2017 JADPRO Live, the annual conference of the Advanced Practitioner Society for Hematology and Oncology (APSHO). Mary Pazdur is the late wife of Richard Pazdur, MD, Director of the Oncology Center...
FDA Expands Approval of Sunitinib Malate for Adjuvant Treatment of Renal Cell Carcinoma After Nephrectomy
Today, the U.S. Food and Drug Administration (FDA) approved sunitinib malate (Sutent) for the adjuvant treatment of adult patients who are at a high risk of recurrent renal cell carcinoma after nephrectomy. “This is the first adjuvant treatment approved for patients with renal cell...
FDA Approves Vemurafenib for Certain Patients With Erdheim-Chester Disease
On November 6, the U.S. Food and Drug Administration (FDA) expanded the approval of vemurafenib (Zelboraf) to include the treatment of certain adult patients with Erdheim-Chester disease (ECD), a rare cancer of the blood. Vemurafenib is indicated to treat patients whose cancer cells have a specific ...
FDA Approves New Treatment for Adults With Mantle Cell Lymphoma
The U.S. Food and Drug Administration (FDA) today granted accelerated approval to acalabrutinib (Calquence) for the treatment of adults with mantle cell lymphoma who have received at least one prior therapy. “Mantle cell lymphoma is a particularly aggressive cancer,” said Richard...
FDA Approves New CDK4/6 Inhibitor for Certain Advanced or Metastatic Breast Cancers
The U.S. Food and Drug Administration today approved abemaciclib (Verzenio) to treat adult patients who have hormone receptor–positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer that has progressed after endocrine therapy. Abemaciclib is...
FDA Approves Copanlisib for Adults With Relapsed Follicular Lymphoma
Today, the U.S. Food and Drug Administration (FDA) granted accelerated approval to copanlisib (Aliqopa) for the treatment of adults with relapsed follicular lymphoma who have received at least two prior systemic therapies. “For patients with relapsed follicular lymphoma, the cancer often...
FDA Pilot Program Aims to Encourage Students to Pursue STEM Careers
When I was in high school, I spent summers working as a restaurant dishwasher, grocery store stock boy, and gardener in northwest Indiana. The idea of spending those weeks learning about science and medicine would not have been an option for me at that time. Yet it is precisely those students who...
FDA Approves Gemtuzumab Ozogamicin for Treatment of Acute Myeloid Leukemia
The U.S. Food and Drug Administration (FDA) today approved gemtuzumab ozogamicin (Mylotarg) for the treatment of adults with newly diagnosed acute myeloid leukemia (AML) whose tumors express the CD33 antigen. The drug was also approved for the treatment of patients aged 2 years and older with...
