Neutropenia News and Research

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Neutropenia is a hematological disorder characterized by an abnormally low number of neutrophils, the most important type of white blood cell, in the blood.

Nektar commences dosing in Phase 1 study of NKTR-102 in combination with 5-FU/leucovorin

Nektar Therapeutics announced today that the first patients have been dosed in a new Phase 1 dose-escalation clinical study to evaluate NKTR-102, the company's lead oncology compound, in combination with 5-fluorouracil (5-FU)/leucovorin in refractory solid tumor cancers. The study is being conducted at University Hospitals Case Medical Center of the Case Comprehensive Cancer Center in Cleveland, Ohio.

24 Jun 2010

Merck proposes to initiate Phase II proof-of-concept clinical study of posaconazole for chronic Chagas disease

Merck today announced plans to initiate a Phase II investigational proof-of-concept clinical study to evaluate its oral antifungal agent posaconazole for the treatment of chronic Chagas disease. Chagas disease results from infection with the parasite Trypanosoma cruzi that is spread by biting insects. The disease is estimated to affect approximately eight million people in Latin America, of whom approximately 30-40 percent will develop serious cardiac disease, digestive disease, or both as a result of this infection.

24 Jun 2010

Pfizer to discontinue commercial availability of Mylotarg for AML in U.S.

Pfizer Inc. announced today that based on discussions with the U.S. Food and Drug Administration (FDA), it will be discontinuing commercial availability of Mylotarg® (gemtuzumab ozogamicin for Injection) (used for the treatment of relapsed acute myeloid leukemia (AML)) in the United States and that it will be voluntarily withdrawing the new drug application (NDA) for Mylotarg effective October 15, 2010.

22 Jun 2010

FDA approves new indication for Tasigna in treatment of rare blood cancer

The U.S. Food and Drug Administration today approved a new indication for Tasigna (nilotinib) for the treatment of a rare blood cancer when it is first diagnosed. The cancer, called Philadelphia chromosome positive chronic phase chronic myeloid leukemia (Ph+ CP-CML), is a slowly progressing blood and bone marrow disease linked to a genetic abnormality.

18 Jun 2010

FDA approves Jevtana to treat men with prostate cancer

The U.S. Food and Drug Administration today approved Jevtana (cabazitaxel), a chemotherapy drug used in combination with the steroid prednisone to treat men with prostate cancer. Jevtana is the first treatment for advanced, hormone-refractory, prostate cancer that has worsened during or after treatment with docetaxel, a commonly used drug for advanced prostate cancer.

18 Jun 2010

$FDA approves Jevtana in combination with prednisone for metastatic hormone-refractory prostate cancer$

FDA approves Jevtana in combination with prednisone for metastatic hormone-refractory prostate cancer

Sanofi-aventis announced today that the U.S. Food and Drug Administration (FDA) has granted marketing authorization for Jevtana® (cabazitaxel) Injection in combination with prednisone for the treatment of patients with metastatic hormone-refractory prostate cancer (mHRPC) previously treated with a docetaxel-containing treatment regimen.

18 Jun 2010

FDA grants Fast Track status for Genzyme's alemtuzumab development program for MS

Genzyme Corporation announced today that its alemtuzumab for multiple sclerosis development program has been granted Fast Track status by the U.S. Food and Drug Administration (FDA). This designation covers patients with relapsing-remitting forms of the disease.

15 Jun 2010

Study confirms impact of febrile neutropenia on chemotherapy delivery in NHL

Data presented at the 15th European Hematology Association (EHA) congress in Barcelona, highlights the impact of febrile neutropenia (FN) on chemotherapy delivery in non-Hodgkin lymphoma (NHL) patients. The IMPACT NHL study showed that unplanned hospitalisations, delays in chemotherapy and reductions of chemotherapy dose leading to suboptimal relative dose intensity (RDI) of chemotherapy were more frequent in patients who experienced FN than those who did not.

14 Jun 2010

Phase III study of REVLIMID for treating patients with multiple myeloma shows improvement in PFS

Celgene International Sàrl announced that data from the planned second interim analysis (median follow-up of 21 months) of a phase III, randomized, double-blind study of continuous REVLIMID (lenalidomide) for the treatment of elderly patients with newly diagnosed multiple myeloma show improvement in progression-free survival, the primary endpoint of the study.

14 Jun 2010

$Data from Phase 1 study of FOLOTYN in patients with relapsed or refractory CTCL presented at EHA 2010$

Data from Phase 1 study of FOLOTYN in patients with relapsed or refractory CTCL presented at EHA 2010

Allos Therapeutics, Inc. today announced updated data from its ongoing dose finding Phase 1 study of FOLOTYN (pralatrexate injection) in patients with relapsed or refractory cutaneous T-cell lymphoma, a group of often slow-growing non-Hodgkins lymphomas that primarily manifest in the skin. These data were presented during a poster presentation at the European Hematology Association meeting being held June 10-13, 2010 in Barcelona, Spain.

11 Jun 2010

Clinical data from investigational study of patients with multiple myeloma presented at ASCO

Celgene International Sàrl announced clinical data from an investigational study of patients with multiple myeloma who were younger than 65 years old and received either lenalidomide (REVLIMID), melphalan and prednisone or melphalan plus autologous stem cell transplant (MEL200) following an induction treatment of lenalidomide plus low-dose dexamethasone (Rd) were presented at the American Society of Clinical Oncology annual meeting.

11 Jun 2010

Abraxis BioScience presents phase 3 trial data on metastatic malignant melanoma

Abraxis BioScience, Inc. presented trial design information from its ongoing phase 3 registration trial of nanoparticle albumin bound (nab®) driven chemotherapy, nab-paclitaxel (ABRAXANE® for Injectable Suspension; paclitaxel albumin protein-bound particles for injectable suspension), in melanoma, an aggressive form of skin cancer that affects more than 68,000 people in the U.S. each year.

11 Jun 2010

$Cell Therapeutics presents data on PIX301 trial of Pixuvri for relapsed or refractory, aggressive NHL$

Cell Therapeutics presents data on PIX301 trial of Pixuvri for relapsed or refractory, aggressive NHL

Cell Therapeutics, Inc. today reported exploratory analyses of the data at study completion from the Company's pivotal PIX301 trial of Pixuvri, the first randomized controlled trial in patients with relapsed or refractory, aggressive non-Hodgkin's lymphoma.

11 Jun 2010

EC approves Nivestim for prevention of FN

Hospira announced today that the EC has approved Nivestim™ (filgrastim) for the prevention of FN, the most serious haematological toxicity that occurs as a result of cancer chemotherapy. Nivestim now has marketing authorisation in all EU member states. Nivestim is expected to reduce the cost of neutropenia treatment.

10 Jun 2010

Combination therapy appears to improve outcome of women with late-stage ovarian cancer

The combination of decitabine and carboplatin appears to improve the outcome of women who have late-stage ovarian cancer. In an upcoming issue of the journal Cancer (online today), Indiana University researchers report four of 10 patients who participated in a phase I clinical trial had no disease progression after six months of treatment. One patient experienced complete resolution of tumor tissue for a period of time.

10 Jun 2010

Positive initial results from Nektar Therapeutics' NKTR-102 Phase 2 study for metastatic breast cancer

Nektar Therapeutics today announced positive preliminary initial results from a two-stage Phase 2 clinical study evaluating single-agent NKTR-102 in women with advanced/metastatic breast cancer patients who have received a prior taxane. The increased use of taxanes in breast cancer often renders tumors resistant to these drugs by the time the disease recurs, thereby underscoring the urgent need for new treatment options with novel mechanisms of action for metastatic disease.

10 Jun 2010

Four-year follow-up results from SPRYCEL Phase 3 study in CML-CP presented at ASCO

Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. today announced four-year follow-up results from a Phase 3 randomized, open-label, dose-optimization study of SPRYCEL® (dasatinib) in chronic-phase chronic myeloid leukemia (CML-CP) patients resistant or intolerant to Gleevec®* (imatinib mesylate). At four years, for all patients administered SPRYCEL 100 mg once daily, overall survival was 82% (95% CI: 76%-88%) and progression-free survival was 66% (95% CI: 57%-74%).

9 Jun 2010

Multiple presentations on nab-driven chemotherapy at 46th ASCO

Abraxis BioScience, Inc. presented abstracts describing 10 trials of nanoparticle albumin bound (nab®) driven chemotherapy, nab-paclitaxel (ABRAXANE® for Injectable Suspension; paclitaxel albumin protein-bound particles for injectable suspension), for the treatment of breast cancer at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago.

9 Jun 2010

Clinical trials of four investigational compounds in solid tumors presented at ASCO Annual Meeting

Millennium: The Takeda Oncology Company today announced data from clinical trials of four investigational compounds in solid tumors presented at the Annual Meeting of the American Society of Clinical Oncology, held in Chicago, Illinois, June 4-8, 2010. These data include an oral presentation on MLN8237, the Company's selective Aurora A kinase inhibitor.

9 Jun 2010

$Phase 2 Study: NKTR-102 holds great therapeutic potential for women with platinum-resistant/refractory ovarian cancer$

Phase 2 Study: NKTR-102 holds great therapeutic potential for women with platinum-resistant/refractory ovarian cancer

Nektar Therapeutics today announced positive results from a Phase 2 clinical study evaluating single-agent NKTR-102 in women with platinum-resistant/refractory ovarian cancer. A total of 68 patients were enrolled with platinum-resistant disease, half of whom were platinum refractory. All 68 patients were evaluable for the primary endpoint of objective response rate using Gynecologic Cancer InterGroup criteria, which is a combination of response by tumor imaging (RECIST) and/or ovarian cancer biomarker (CA-125) criteria.

8 Jun 2010

Neutropenia News and Research

Further Reading

Nektar commences dosing in Phase 1 study of NKTR-102 in combination with 5-FU/leucovorin

Merck proposes to initiate Phase II proof-of-concept clinical study of posaconazole for chronic Chagas disease

Pfizer to discontinue commercial availability of Mylotarg for AML in U.S.

FDA approves new indication for Tasigna in treatment of rare blood cancer

FDA approves Jevtana to treat men with prostate cancer

FDA approves Jevtana in combination with prednisone for metastatic hormone-refractory prostate cancer

FDA grants Fast Track status for Genzyme's alemtuzumab development program for MS

Study confirms impact of febrile neutropenia on chemotherapy delivery in NHL

Phase III study of REVLIMID for treating patients with multiple myeloma shows improvement in PFS

Data from Phase 1 study of FOLOTYN in patients with relapsed or refractory CTCL presented at EHA 2010

Clinical data from investigational study of patients with multiple myeloma presented at ASCO

Abraxis BioScience presents phase 3 trial data on metastatic malignant melanoma

Cell Therapeutics presents data on PIX301 trial of Pixuvri for relapsed or refractory, aggressive NHL

EC approves Nivestim for prevention of FN

Combination therapy appears to improve outcome of women with late-stage ovarian cancer

Positive initial results from Nektar Therapeutics' NKTR-102 Phase 2 study for metastatic breast cancer

Four-year follow-up results from SPRYCEL Phase 3 study in CML-CP presented at ASCO

Multiple presentations on nab-driven chemotherapy at 46th ASCO

Clinical trials of four investigational compounds in solid tumors presented at ASCO Annual Meeting

Phase 2 Study: NKTR-102 holds great therapeutic potential for women with platinum-resistant/refractory ovarian cancer

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