Neutropenia News and Research

RSS

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

Phase 2 MS clinical trial data continues to show durable reductions in relapse rate

Genzyme Corporation reported today that four-year follow-up data from its completed Phase 2 multiple sclerosis (MS) trial continued to show durable reductions in relapse rate and sustained accumulation of disability three years after the majority of patients received their last course of the investigational compound alemtuzumab.

14 Sep 2009

FDA approves Supplemental New Drug Application for DOXIL

Centocor Ortho Biotech Products, L.P. today announced that it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding its Supplemental New Drug Application (sNDA) for DOXIL (doxorubicin HCI liposome injection) in combination with docetaxel for the treatment of women with locally advanced and metastatic breast cancer.

10 Sep 2009

Millennium's sNDA to be reviewed by the FDA

The Takeda Oncology Company today announced the U.S. Food and Drug Administration (FDA) has accepted for review the Company’s supplemental new drug application (sNDA) based on long- term overall survival (OS) data from the landmark VISTA1 trial examining the use of VELCADE based therapy in patients with previously untreated multiple myeloma (MM).

3 Sep 2009

FDA: Randomized clinical trial necessary to better interpret Clolar’s efficacy and safety in adult AML

Genzyme Corporation (Nasdaq: GENZ) announced today that the FDA’s Oncologic Drugs Advisory Committee voted 9 to 3 that a randomized, controlled trial is needed to support the currently proposed label expansion for Clolar® (clofarabine) in adult myeloid leukemia (AML). The committee found that the single-arm clinical study results submitted to support the label expansion showed Clolar was an active agent in acute AML patients, but concluded that a randomized clinical trial should be necessary to better interpret Clolar’s efficacy and safety in the proposed patient population.

2 Sep 2009

FDA approves the usage of Valcyte for preventing CMV disease in pediatric patients

Roche announced today that the U.S. Food and Drug Administration (FDA) has approved Valcyte(R) (valganciclovir hydrochloride) for the prevention of cytomegalovirus (CMV) disease in pediatric kidney and heart transplant patients (4 months to 16 years of age) at high risk of developing CMV disease.

31 Aug 2009

Initial results of the CURRENT-OASIS 7 clinical trial due for release

Today, the OASIS study group will present initial results of the CURRENT-OASIS 7 clinical trial at the European Society of Cardiology congress in Barcelona. Sanofi-aventis and Bristol-Myers Squibb, co-commercialization and co-development partners for PLAVIX(clopidogrel bisulfate), were sponsors of the study.

30 Aug 2009

Genzyme’s supplemental NDA for treating adult AML with Clolar to be discussed by the FDA

Genzyme Corporation (Nasdaq: GENZ) announced today that its supplemental New Drug Application for Clolar® (clofarabine) will be discussed Tuesday, September 1 at a public meeting of the FDA’s Oncologic Drugs Advisory Committee in Silver Spring, Maryland. The panel is expected to consider the clinical trial results Genzyme submitted to support the approval and labeling of Clolar to treat older adult patients with acute myeloid leukemia (AML), the most common type of acute leukemia in adults.

29 Aug 2009

Neurogen stockholders to receive $11 million in Ligand Pharmaceuticals common stock as part of acquisition deal

Ligand Pharmaceuticals Incorporated (NASDAQ:LGND) and Neurogen Corporation (NASDAQ:NRGN) announced today they have entered into a definitive merger agreement under which Ligand will acquire Neurogen. Under the transaction, Neurogen stockholders will receive an estimated $11 million in Ligand common stock and will be granted Contingent Value Rights (“CVRs”) under four CVR agreements.

25 Aug 2009

InterMune receives $20 million event payment from Roche for initiating the Phase 2b trial of RG7227/ ITMN-191

Roche (SIX: ROG.VX; RO.S, OTCQX: RHHBY) and InterMune, Inc. (Nasdaq: ITMN) today announced that the first patient has been dosed in a Phase 2b study evaluating the hepatitis C virus (HCV) protease inhibitor, RG7227/ ITMN-191, in combination with PEGASYS(R) (pegylated interferon alfa-2a) and COPEGUS(R) (ribavirin). The study, to be conducted at 45 sites globally, will further define the safety and efficacy profile of RG7227/ ITMN-191, for a treatment duration of up to 24 weeks. Approximately 300 treatment-naive patients chronically infected with HCV genotype 1 - the most difficult to treat form of the virus - will participate.

20 Aug 2009

Cost effectiveness study looks at potential value of new genetic test for guiding chemotherapy treatment

For the 29,000 patients in the United States with metastatic colorectal cancer, chemotherapy with irinotecan is a standard treatment that has been shown to improve survival. But for more than one in 10 of these patients, a variation in their DNA means that this treatment could result in a severe reduction in their white blood cell count, leading to a high risk of bacterial infection and possible subsequent death.

27 Jul 2009

Vandetanib shows clinical benefit when combined with docetaxel for lung cancer

When combined with standard chemotherapy, an international Phase III trial has shown that the oral targeted therapy vandetanib improves progression-free survival for patients with advanced non-small cell lung cancer, according to research from The University of Texas M. D. Anderson Cancer Center.

1 Jun 2009

Study shows that induction chemotherapy prior to chemoradiotherapy significantly increases time-to-treatment failure in comparison to standard chemoradiotherapy alone

The Spanish Head and Neck Cancer Cooperative Group (TTCC) announced today that Induction Chemotherapy (IC) delivered prior to standard ChemoRadiotherapy (CRT), a treatment paradigm defined as sequential therapy, compared to upfront CRT alone, significantly prolonged Time-to-Treatment Failure (TTF) for patients with unresectable Locally Advanced Head and Neck Cancer (LAHNC).

1 Jun 2009

Combination of temsirolimus and bryostatin appears safe and active in metastatic kidney cancer

Fox Chase Cancer Center investigators report that a two-drug blockade of mTOR signaling appears safe in metastatic kidney cancer in a phase I trial. Early data suggests that a combination of temsirolimus and bryostatin may be active in patients with rare forms of renal cell cancer, which are less likely to respond to other targeted therapies.

31 May 2009

FDA grants full approval for Sprycel (dasatinib) for chronic myeloid leukemia

Bristol-Myers Squibb Company has announced that the U.S. Food and Drug Administration (FDA) has granted full approval for Sprycel (dasatinib) for the treatment of adults in all phases of chronic myeloid leukemia (CML) (chronic, accelerated, or myeloid or lymphoid blast phase) with resistance or intolerance to prior therapy including Gleevec (imatinib mesylate).

27 May 2009

Genentech and Biogen Idec submit applications to FDA for Rituxan in chronic lymphocytic leukemia

Genentech, Inc. and Biogen Idec today announced that the companies submitted two supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA) for Rituxan (rituximab) plus standard chemotherapy for people with previously untreated or treated chronic lymphocytic leukemia (CLL).

20 May 2009

Sanofi-aventis to acquire Oforta, oral chronic lymphocytic leukemia treatment

Sanofi-aventis U.S. announced today that it has acquired from biotechnology company Antisoma plc the U.S. commercial rights to Oforta (fludarabine phosphate film-coated tablets), an oral B-cell chronic lymphocytic leukemia (CLL) drug. Oforta is currently approved in the United States for use as a second-line therapy to treat adults with B-cell CLL.

12 May 2009

Seroquel XR supplemental NDA recommended for approval

The U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) conducted a review of the safety and efficacy of supplemental new drug applications (sNDA) for Seroquel XR (quetiapine fumarate) extended-release tablets proposed for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD).

9 Apr 2009

Gleevec reduces risk of cancer returning in patients with life-threatening gastrointestinal stromal tumors

Data published online and in an upcoming print issue of The Lancet show that Gleevec (imatinib mesylate) tablets, when taken after surgery, substantially reduces the rate of recurrence of Kit-positive gastrointestinal stromal tumors (GIST) compared with placebo.

20 Mar 2009

Study of Rituxan (rituximab) in lupus nephritis misses primary endpoint

Genentech, Inc. and Biogen Idec has announced that a Phase III study of Rituxan (rituximab) plus mycophenolate mofetil (MMF) and corticosteroids in patients with lupus nephritis did not meet its primary endpoint of significantly reducing disease activity at 52 weeks.

11 Mar 2009

European Commission and US FDA approve intravenous formulation of temozolomide

Schering-Plough Corporation (NYSE:SGP) today announced that the European Commission and the US FDA both approved the intravenous (IV) formulation of temozolomide as an alternative to the already approved oral form of the drug.

5 Mar 2009