Centocor Ortho Biotech Statement on the FDA ODAC Opinion Regarding DOXIL(R) for Treatment of Advanced Breast Cancer
... absolute neutrophil count, hemoglobin level, or
neutropenia with fever) may require dose reduction, delay in ... or hemorrhage
Sepsis occurring during
neutropenia has resulted in discontinuation of treatment and ... 5 percent (DOXIL vs topotecan, respectively) were
neutropenia (12 percent vs 76 percent) and anemia (6 percent ...
Amgen Highlights Data to Be Presented at ASCO
...
Neulasta (R) (pegfilgrastim)
neutropenia is a common and potentially dangerous side effect ... mortality in cancer patients experiencing febrile
neutropenia (neutropenia with fever) based on clinical ... in patients with cancer experiencing febrile
neutropenia
Lead Author: Barron R
Abstract ...
European Commission and United States Food and Drug Administration (FDA) Both Approve New Options for Patients With Certain Primary Brain Tumors
... and adverse events were combined, Grade 3 or 4
neutropenia occurred in 8% and Grade 3 or 4 platelet ... 9.5% of patients over age 70 experienced Grade 4
neutropenia or thrombocytopenia in the first cycle, ... equal to age 70, 7% and 5.5% experienced Grade 4
neutropenia or thrombocytopenia in the first cycle, ...
Prescription Copay Assistance for Patients taking Gleevec or Tasigna for Philadelphia chromosome-positive Chronic Myelogenous Leukemia (Ph+ CML)
... adverse reactions were thrombocytopenia (28%),
neutropenia (28%), elevated lipase (15%), and hyperglycemia ... adverse reactions were thrombocytopenia (37%),
neutropenia (37%), anemia (23%), and elevated lipase (17%). ... (NCI Grades 3/4) lab abnormalities - including
neutropenia (3.6%-48%), anemia (1%-42%), thrombocytopenia ...
Scientists identify new congenital neutropenia syndrome and causative gene mutation
... a new syndrome associated with severe congenital
neutropenia (SCN), a rare disorder in which children lack ... in this newly defined group of severe congenital
neutropenia patients," said Christoph Klein, M.D., Ph.D., ... lead author of the study.
Severe congenital
neutropenia (SCN) is a rare disorder, with an incidence of ...
Novel treatments show improvements in survival and response rates for leukemia and lymphoma
... favorable.
There were four cases of febrile
neutropenia with eight patients requiring a dose-modification ... mucositis (14 percent), anemia (12 percent), and
neutropenia (11 percent).
Immunochemotherapy With ... in the FC arm. While FCR was found to cause more
neutropenia (33.6 percent versus 20.9 percent) and leukopenia ...
Novel Treatments Demonstrate Improvements in Overall Survival and Response Rates in Difficult-To-Treat Forms of Leukemia and Lymphoma
... quite favorable. There were four cases of febrile
neutropenia with eight patients requiring a dose-modification ... mucositis (14 percent), anemia (12 percent), and
neutropenia (11 percent).
Immunochemotherapy ... in the FC arm. While FCR was found to cause more
neutropenia (33.6 percent versus 20.9 percent) and leukopenia ...
Study Showed ALIMTA(R) (pemetrexed for injection) Improved Survival in Certain Types of Non-Small Cell Lung Cancer
... NSCLC were
anemia (8 vs 7); leukopenia (5 vs 28);
neutropenia (5 vs 40);
thrombocytopenia (2 vs 1); ALT elevation (3 vs 1); febrile
neutropenia (2
vs 13); infection without
neutropenia (6 vs 4); infection/febrile
neutropenia - other ...
ASCO Study Confirms Importance of Histology in Treatment of Non-Small Cell Lung Cancer With ALIMTA (pemetrexed for injection)
... NSCLC were
anemia (8 vs 7); leukopenia (5 vs 28);
neutropenia (5 vs 40);
thrombocytopenia (2 vs 1); ALT elevation (3 vs 1); febrile
neutropenia (2
vs 13); infection without
neutropenia (6 vs 4); infection/febrile
neutropenia -- other ...
New IDSA Clinical Practice Guidelines Recommend NOXAFIL(R) (Posaconazole) for Antifungal Prophylaxis in Certain High-Risk Patients
... with hematologic malignancies with
prolonged
neutropenia from chemotherapy.
In October 2006, the FDA ... for AML or MDS expected
to result in prolonged
neutropenia and HSCT recipients who are undergoing
high-dose ... refractory OPC patients
included fever (13%) and
neutropenia (10%).
Coadministration with the CYP3A4 ...
Cell Therapeutics Completes Pixantrone NDA Submission and Requests Priority Review
... The most common grade 3/4 adverse event observed on the pixantrone arm was
neutropenia in 41.2% of patients versus 19.4% on the comparator arm. However, the incidence of grade 3/4 febrile
neutropenia was only 7.4% versus 3.0% in the comparator arm. Grade 3/4 infections had ...
NKTR-105 Demonstrates Superior Antitumor Activity and Improved Pharmacokinetics Over Docetaxel in Preclinical Studies Presented at AACR
... studies, NKTR-105 demonstrated superior antitumor activity with no
neutropenia in multiple tumor models, indicating that NKTR-105 may enable sustained ... required no pre-treatment with corticosteroids and shown no evidence of
neutropenia in patients to date.
About NKTR-105
NKTR-105 is a novel ...
Cell Therapeutics Initiating Rolling NDA Submission for Pixantrone
... arm, p = 0.003).
Pixantrone recipients had a low incidence of severe
neutropenia complicated by either fever or documented infections, or severe vomiting ... arm. The pixantrone patients had a higher incidence of leucopenia and
neutropenia and numerically more severe cardiac events (5 vs. 2) with only 1 ...
Telik Announces Fourth Quarter and 2008 Year End Financial Results and 2009 Financial Guidance
... 2 studies for Myelodysplastic Syndrome (MDS) and Chemotherapy Induced
neutropenia (CIN). The company also plans to initiate a Phase 2 Study in Severe Chronic Idiopathic
neutropenia (SCIN) this year. The company will pursue a corporate partnership for the ...
Data on VELCADE(R) (Bortezomib) for Injection Based Therapies to be Presented at the International Myeloma Workshop
... (21%), cough and insomnia (each 20%), rash (18%), arthralgia (17%),
neutropenia and dizziness (excluding vertigo) (each 17%), pain in limb and abdominal ... 1 episode of ¿Grade 4 toxicity, most commonly thrombocytopenia (5%) and
neutropenia (3%). A total of 50% of patients experienced serious adverse events (SAEs) ...
InterMune Reports Results from Triple Combination Study of ITMN-191
... by the investigator to be unrelated to ITMN-191. The other two were
neutropenia and indirect bilirubin elevation.
neutropenia occurred with a similar pattern, frequency and severity in the placebo and ...
Ortho Biotech Announces NDA Submission for Trabectedin for the Treatment of Relapsed Ovarian Cancer
... respectively, were:
Hematological reactions including
neutropenia (77% versus 38%, with febrile
neutropenia occurring in 8% of the cases and sepsis in 1% of the cases), leucopenia ...
FDA Approves VELCADE(R) (Bortezomib) for Injection for Patients with Previously Untreated Multiple Myeloma
... with MP vs MP, respectively, were thrombocytopenia (52% vs
47%),
neutropenia (49% vs 46%), nausea (48% vs 28%), peripheral neuropathy
(47% vs 5%), ... than or equal to Grade 4 toxicity, most commonly
thrombocytopenia (5%) and
neutropenia (3%). A total of 50% of patients
experienced serious adverse events (SAEs) ...
Publication of Clinical Results Underscores VELCADE(R) (Bortezomib) For Injection Based Therapy As a Standard of Care In Newly Diagnosed Multiple Myeloma Patients
... of the individual agents in the combination, including
thrombocytopenia,
neutropenia and peripheral neuropathy.
About Multiple Myeloma
Multiple myeloma is ... 1 episode of >/= Grade 4 toxicity, most commonly
thrombocytopenia (5%) and
neutropenia (3%). A total of 50% of patients
experienced serious adverse events (SAEs) ...
JCI table of contents: Feb. 21, 2008
... in patients with too few white blood cells may lead to leukemia
neutropenia is a disease characterized by low numbers of white blood cells called ... infections. A high proportion of patients who have severe congenital
neutropenia have mutations in their CSFR3 gene, which is responsible for making the ...
St. Jude Finds Risk Factors for Severe RSV Infection in Immunocompromised Children
... is not a risk factor for
lower respiratory track infection, Gaur said.
neutropenia is an abnormally
low level of neutrophils, immune system cells that engulf ... study shows that for RSV,
which is a viral infection, lymphopenia and not
neutropenia is what
identifies children at risk.
Previous studies have shown that ...
St. Jude finds risk factors for severe RSV infection in immunocompromised children
... is not a risk factor for lower respiratory track infection, Gaur said.
neutropenia is an abnormally low level of neutrophils, immune system cells that engulf ... study shows that for RSV, which is a viral infection, lymphopenia and not
neutropenia is what identifies children at risk.
Previous studies have shown that ...
Pharmion and MethylGene Present Favorable Clinical Data From Combination MGCD0103/Vidaza(R) Study in Myelodysplastic Syndromes and Acute Myelogenous Leukemia at The 49th American Society of Hematology (ASH) Meeting
... or refractory anemia with ringed sideroblasts (RARS)
if accompanied by
neutropenia or thrombocytopenia or requiring
transfusions; refractory anemia with ... hypokalemia (31.3%).
Because treatment with Vidaza is associated with
neutropenia and
thrombocytopenia, complete blood counts should be performed as needed ...
Favorable Vote From FDA Advisory Committee on SEROQUEL Pediatric Supplemental New Drug Applications
... of therapy. In these patients, SEROQUEL should be discontinued at the first sign of a decline in WBC absent other causative factors. Patients with
neutropenia should be carefully monitored, and SEROQUEL should be discontinued in any patient if the absolute neutrophil count is 1000/mm3.
Tardive ...
New survey highlights growing concern about risk of infection in cancer patients
... Each year, 60,000 cancer patients are hospitalized for chemotherapy-induced neutropenia, and a patient dies every two hours from this complication.
neutropenia also can potentially disrupt chemotherapy treatment, including both dose delays and dose reductions. Studies show that for certain types of cancer, ...
Poniard Pharmaceuticals Announces Positive Efficacy and Safety Data From Phase 2 Clinical Trial of Picoplatin in Men With Metastatic Prostate Cancer
... report evidence of neuropathy in 30 percent of patients, including severe neuropathy (Grade 3/4) in almost 2 percent of patients.i
neutropenia was the main hematologic toxicity. In contrast with picoplatin monotherapy in previous studies, thrombocytopenia was less severe and less frequent ...
New Survey Highlights Growing Concern About Risk of Infection in Cancer Patients and Emerging Antibiotic Resistance
... Each year, 60,000 cancer patients are hospitalized for chemotherapy-induced neutropenia, and a patient dies every two hours from this complication.
neutropenia also can potentially disrupt chemotherapy treatment, including both dose delays and dose reductions. Studies show that for certain types of cancer, ...
New Data Demonstrate RISPERDAL(R) CONSTA(R) (Risperidone) Long-Acting Treatment May Improve Health Outcomes and Reduce Hospitalizations in Patients with Schizophrenia
... be used with caution in patients with known cardiovascular disease, and conditions that would predispose patients to hypotension.
Leukopenia,
neutropenia and Agranulocytosis have been reported with antipsychotics, including risperidone. Patients with a pre-existing low white blood cell count (WBC) or ...
FDA Grants Approval for Use of RISPERDAL(R) CONSTA(R) as Both a Monotherapy and Adjunctive Therapy in the Maintenance Treatment of Bipolar I Disorder
... be used with caution in patients with known cardiovascular disease, and conditions that would predispose patients to hypotension.
Leukopenia,
neutropenia and Agranulocytosis have been reported with antipsychotics, including risperidone. Patients with a pre-existing low white blood cell count (WBC) or ...
FDA Advisory Committee Recommendation on SEROQUEL XR Supplemental New Drug Applications
... these patients, SEROQUEL XR and SEROQUEL should be discontinued at the first sign of a decline in WBC absent other causative factors. Patients with
neutropenia should be carefully monitored, and SEROQUEL XR and SEROQUEL should be discontinued in any patient if the absolute neutrophil count is < 1000/mm3. ...
Poniard Announces Publication of Results of Picoplatin Phase 2 Study in Journal of Clinical Oncology
... control rate was 47 percent in the 77 evaluable patients. The most common side effects observed were hematologic and included thrombocytopenia,
neutropenia and anemia. No grade 3 or 4 neurotoxicity or nephrotoxicity and no treatment-related deaths occurred in the study.
"The publication of these ...
FDA Advisory Committee Recommendation on SEROQUEL XR Supplemental New Drug Applications
... these patients, SEROQUEL XR and SEROQUEL should be discontinued at the first sign of a decline in WBC absent other causative factors. Patients with
neutropenia should be carefully monitored, and SEROQUEL XR and SEROQUEL should be discontinued in any patient if the absolute neutrophil count is < 1000/mm3. ...
FDA Advisory Committee Documents for SEROQUEL XR Available on AstraZeneca Web Site
... therapy. In these patients, SEROQUEL XR should be discontinued at the first sign of a decline in WBC absent other causative factors. Patients with
neutropenia should be carefully monitored, and SEROQUEL XR should be discontinued in any patient if the absolute neutrophil count is < 1000/mm3.
Tardive ...
Gleevec(R) substantially reduces risk of cancer returning in patients with life-threatening gastrointestinal stromal tumors (GIST), The Lancet reports
...
In Phase III unresectable or metastatic GIST trials (400 mg/day; 800 mg/day), severe (NCI Grades 3/4/5) lab abnormalities - including
neutropenia (3%; 4%) and anemia (5%; 6%) - and severe adverse reactions (NCI Grades 3/4/5), including severe fluid retention (9% to 13%) and edema (9%; 13%), ...
AstraZeneca Announces SEROQUEL XR is Now Available to Treat Bipolar Depression
... therapy. In these patients, SEROQUEL XR should be discontinued at the first sign of a decline in WBC absent other causative factors. Patients with
neutropenia should be carefully monitored, and SEROQUEL XR should be discontinued in any patient if the absolute neutrophil count is < 1000/cubic mm.
...
PEGASYS(R) Proven Effective as Hepatitis C Treatment for Latino Patients, According to Article in The New England Journal of Medicine
... percent), pyrexia (41 percent), myalgia (40 percent), irritability/anxiety/nervousness (33 percent), insomnia (30 percent), alopecia (28 percent),
neutropenia (27 percent), nausea/vomiting (25 percent), rigors (25 percent), anorexia (24 percent), injection site reaction (23 percent), arthralgia (22 ...
Schering-Plough Announces FDA Approval of PEGINTRON(TM) and REBETOL(R) Combination Therapy for Treating Pediatric Hepatitis C
... percent were treated for clinical hypothyroidism.
Dose modifications were required in 25 percent of patients, most commonly for anemia,
neutropenia and weight loss. Therapy was discontinued prematurely in two percent of the patients.
About Hepatitis C
Hepatitis C is a serious ...
Exjade(R) Benefits Chronically Transfused Patients by Significantly Reducing Toxic Iron That Can Damage Key Organs, According to Landmark Trial
... patients in Study 1, and monthly monitoring is recommended.
There have been postmarketing reports of cytopenias (including agranulocytosis,
neutropenia and thrombocytopenia) in patients treated with EXJADE. Some of these patients died. The relationship of these episodes to treatment with EXJADE is ...
Eisai Will Initiate First Head-to-Head Study Comparing Dacogen(R) (decitabine for injection) and Vidaza(R) (azacitidine) in Patients with Myelodysplastic Syndromes
... child while receiving treatment with Dacogen(R) and for two months afterwards. The most commonly occurring adverse reactions with Dacogen(R) include
neutropenia (90%), thrombocytopenia (89%), anemia (82%), pyrexia (53%), fatigue (48%), nausea (42%), cough (40%), petechiae (39%), constipation (35%), and ...
Global Growth Factors (Blood and Tissue) Market to Reach $52.1 Billion by 2012, According to New Report by Global Industry Analysts
... billion by the year 2012. Growth will also be encouraged by the recent success of commercialized products in new therapeutic applications such as
neutropenia prevention and treatment.
San Jose, CA (PRWEB) November 10, 2008 -- Age-related conditions such as Alzheimer's disease, ...