Anthracycline News and Research

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Anthracycline is a type of antibiotic that comes from certain types of Streptomyces bacteria. Anthracyclines are used to treat many types of cancer. Anthracyclines damage the DNA in cancer cells, causing them to die. Daunorubicin, doxorubicin, and epirubicin are anthracyclines.

Abraxis BioScience to present updated survival findings from ABRAXANE Phase I/II trial at 101st AACR meeting

Abraxis BioScience, Inc., a fully integrated biotechnology company, announced that the updated survival findings from a Phase I/II clinical trial evaluating the chemotherapy agent ABRAXANE® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in combination with gemcitabine for first-line treatment of patients with metastatic pancreatic cancer will be discussed during a keynote address on April 20 at the 101st Annual Meeting of the American Association for Cancer Research (AACR) being held in Washington, D.C.

9 Apr 2010

Cell Therapeutics receives FDA Complete Response Letter for Pixuvri NDA

Cell Therapeutics, Inc. today announced that it had received a Complete Response Letter from the U.S. Food and Drug Administration regarding its New Drug Application for Pixuvri™ (pixantrone dimaleate) for relapsed or refractory aggressive non-Hodgkin's lymphoma ("NHL").

9 Apr 2010

Eisai Europe seeks EMA approval of eribulin mesylate for locally advanced or metastatic breast cancer

Eisai Europe Ltd. today announced that it has submitted a marketing authorization application to the European Medicines Agency (EMA) for approval of eribulin mesylate, also known as 'E7389', for the treatment of locally advanced or metastatic breast cancer in Europe. Eribulin mesylate, a non-taxane microtubule dynamics inhibitor, is an investigational chemical compound discovered and developed by Eisai. Regulatory applications for eribulin mesylate have also been submitted in the United States and Japan.

31 Mar 2010

Eisai seeks simultaneous approval of eribulin mesylate in U.S., EU and Japan

Eisai Inc. today announced that it has submitted simultaneous regulatory applications for approval of eribulin mesylate (also known as E7389) for the treatment of locally advanced or metastatic breast cancer to agencies in Japan, the United States and the European Union (EU). Eribulin, a non-taxane microtubule dynamics inhibitor, is an investigational chemical compound discovered and developed by Eisai.

31 Mar 2010

Abnormality on chromosome 17 helps detect breast cancer tumour's response to anthracyclines

British researchers have discovered a new way of detecting which breast cancer patients are going to respond best to chemotherapy that includes anthracycline antibiotics. The study has found that an abnormality on chromosome 17, called CEP17, is not only associated with a worse outcome for patients, but also that its presence is a highly significant indicator that the tumour will respond to anthracyclines. The research will be presented at the European Breast Cancer Conference (EBCC7) Thursday 25th March.

26 Mar 2010

$CTI's pixantrone trial for relapsed/refractory aggressive NHL: FDA ODAC finds data inadequate for approval$

CTI's pixantrone trial for relapsed/refractory aggressive NHL: FDA ODAC finds data inadequate for approval

Cell Therapeutics, Inc. announced today that the U.S. Food and Drug Administration's Oncologic Drugs Advisory Committee panel voted unanimously that clinical trial data was not adequate to support approval of pixantrone for patients with relapsed or refractory aggressive non-Hodgkin's lymphoma.

23 Mar 2010

Abraxis BioScience's Phase 3 trial comparing ABRAXANE with Taxol injection meets primary endpoint

Abraxis BioScience, Inc. today announced that its randomized registrational Phase 3 clinical trial comparing ABRAXANE® (protein-bound paclitaxel) with Taxol® (paclitaxel) injection, both in combination with carboplatin, met the study’s primary endpoint by demonstrating that ABRAXANE showed a significant improvement in overall response rate as compared to Taxol, in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC), as assessed by independent radiologist review.

17 Mar 2010

Challenges in treating AML and recent updates to NCCN Guidelines presented at NCCN Annual Conference

Using risk stratification to assist in treatment selection was just one of the focal points at a recent presentation of the NCCN Clinical Practice Guidelines for Oncology (NCCN Guidelines™) for Acute Myeloid Leukemia (AML) at the NCCN 15th Annual Conference.

15 Mar 2010

SpePharm Holding acquires global rights to Savene from TopoTarget

SpePharm Holding, BV today announced the acquisition of the worldwide (with the exception of North and South America) rights to Savene® from TopoTarget A/S (Copenhagen, Denmark). As part of the acquisition SpePharm will also take on the European sales force of TopoTarget. Savene®, which has been marketed by TopoTarget since its approval by the EMEA in July 2006, is the only approved product for the treatment of extravasations, or leakage out of the blood stream, of certain commonly used anticancer drugs known as anthracyclines.

4 Mar 2010

Genentech's Avastin combination Phase III study in advanced stomach cancer does not meet primary endpoint

Genentech, Inc., a wholly owned member of the Roche Group, today announced that a Phase III study (AVAGAST) did not meet its primary endpoint of showing Avastin® (bevacizumab) plus Xeloda® (capecitabine) or 5-FU and cisplatin chemotherapy extended the lives of people with inoperable or advanced stomach (gastric) cancer, compared to chemotherapy alone.

23 Feb 2010

FDA approves Rituxan-FC combination therapy for CLL

Genentech, Inc., a wholly owned member of the Roche Group, and Biogen Idec announced today the U.S. Food and Drug Administration (FDA) approved Rituxan® (rituximab) in combination with fludarabine and cyclophosphamide (FC) for people with previously untreated and previously treated CD20-positive chronic lymphocytic leukemia (CLL).

18 Feb 2010

FDA approves new drug combination for hormone positive and HER2-positive advanced breast cancer

The U.S. Food and Drug Administration today approved Tykerb (lapatinib) in combination with Femara (letrozole) to treat hormone positive and HER2-positive advanced breast cancer in postmenopausal women for whom hormonal therapy is indicated.

30 Jan 2010

FDA grants accelerated approval for GlaxoSmithKline's TYKERB

GlaxoSmithKline (NYSE: GSK) announced today that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for a new combination regimen using TYKERB® (lapatinib) as a first-line, all-oral treatment for women with metastatic breast cancer.

29 Jan 2010

Researchers identify new gene signature that predicts cancer recurrence in certain breast tumors

Researchers at Dana-Farber Cancer Institute have discovered a gene activity signature that predicts a high risk of cancer recurrence in certain breast tumors that have been treated with commonly used chemotherapy drugs.

24 Jan 2010

Enzon Pharmaceuticals treats first patient in Phase 2 studies of PEG-SN38

Enzon Pharmaceuticals, Inc. today announced that the first patient has been treated in the Phase 2 studies of PEG-SN38 for metastatic breast cancer. PEG-SN38 or EZN-2208 is Enzon’s PEGylated form of SN38, the active metabolite of the cancer drug Camptosar® (irinotecan HCl injection).

6 Jan 2010

Cell Therapeutics supports Code on Interactions with Healthcare Professionals

Cell Therapeutics, Inc. announced today its support of the Pharmaceutical Research Manufacturers of America's (PhRMA) "Code on Interactions with Healthcare Professionals, revised July 2008" (PhRMA Code). Adherence to the Code is voluntary for commercial biotechnology and pharmaceutical companies.

22 Dec 2009

EMEA grants orphan drug designation for pixantrone in Europe

Cell Therapeutics, Inc. ("CTI") announced today that the European Medicines Agency (EMEA) has granted pixantrone orphan drug designation for the treatment of DLBCL which accounts for about 80% of aggressive non-Hodgkin's lymphoma.

21 Dec 2009

ODAC to review Cell Therapeutics' NDA for pixantrone

Cell Therapeutics, Inc. (CTI) announced today that on February 10, 2010 the U.S. Food and Drug Administration's Oncologic Drugs Advisory Committee (ODAC) will review the New Drug Application (NDA) for pixantrone for the treatment of relapsed/refractory aggressive non-Hodgkin's lymphoma (NHL).

17 Dec 2009

Results from five new studies on Genomic Health's Oncotype DX breast cancer test announced

Genomic Health, Inc. today announced results from five new studies on its Oncotype DX® breast cancer test, a multi-gene expression test that physicians currently use to predict the likelihood of chemotherapy benefit and recurrence risk for patients with early-stage breast cancer.

16 Dec 2009

INS cites FDA-approved Totect antidote for anthracycline extravasations

The third edition of Infusion Nursing: An Evidence-Based Approach, published by the Infusion Nurses Society (INS), includes Totect(®), the only FDA-approved treatment for anthracycline extravasation. Anthracyclines are a group of chemotherapy medications including daunorubicin, doxorubicin, idarubicin and epirubicin that have been used in the treatment of various types of cancer since the early 1970s.

15 Dec 2009