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.

Impact of cancer treatment on cardiovascular function

For the past two decades, cancer therapy has become more sophisticated and effective, resulting in an ever-expanding group of long-term cancer survivors. There is also a growing awareness of the potentially negative effects of cancer treatment on the heart and the management of cardiac disease during and after cancer therapy.

22 Sep 2010

FDA decides to review information on Avastin for advanced HER2-negative breast cancer

Genentech, Inc., a member of the Roche Group, today announced that information submitted by the company to the U.S. Food and Drug Administration (FDA) during the review of the supplemental Biologics License Applications (sBLAs) for Avastin (bevacizumab) for previously untreated (first-line) advanced HER2-negative breast cancer has been deemed a major amendment.

18 Sep 2010

$Cell Therapeutics to appeal FDA decision on pixantrone NDA for relapsed/refractory aggressive NHL$

Cell Therapeutics to appeal FDA decision on pixantrone NDA for relapsed/refractory aggressive NHL

Cell Therapeutics, Inc. today announced that it intends to appeal the U.S. Food and Drug Administration's previously disclosed decision regarding the pixantrone New Drug Application ("NDA") to treat patients with relapsed/refractory aggressive non-Hodgkin's lymphoma ("NHL").

14 Sep 2010

FDA denies accelerated approval of Genentech's trastuzumab-DM1 (T-DM1) BLA for metastatic breast cancer

In its review of the BLA, the FDA stated the T-DM1 trials did not meet the standard for accelerated approval because all available treatment choices approved for metastatic breast cancer, regardless of HER2 status, had not been exhausted in the study population.

27 Aug 2010

CTI announces EMEA's validation of expanded PIP for pixantrone

Cell Therapeutics, Inc. announced today that it has received notice that the European Medicines Agency has validated the expanded Pediatric Investigation Plan that CTI filed in July for pixantrone for the treatment of relapsed or refractory, aggressive non-Hodgkin's lymphoma (NHL).

16 Aug 2010

$CTI files SPA with FDA for new pixantrone phase III trial in relapsed or refractory aggressive B-Cell NHL$

CTI files SPA with FDA for new pixantrone phase III trial in relapsed or refractory aggressive B-Cell NHL

Cell Therapeutics, Inc. today announced it has filed for a Special Protocol Assessment ("SPA") with the U.S. Food and Drug Administration ("FDA") for the design of its new phase III trial of pixantrone for patients with relapsed or refractory aggressive B-Cell non-Hodgkin's lymphoma ("NHL").

4 Aug 2010

New Zealand MEDSAFE approves ABRAXANE for metastatic breast cancer

Abraxis BioScience, Inc., a fully integrated, global biotechnology company, and Specialised Therapeutics Ltd. today announced that MEDSAFE, the New Zealand Medicines and Medical Devices Safety Authority, has approved for marketing ABRAXANE® (nanoparticle albumin-bound paclitaxel) for the treatment of metastatic breast cancer after failure of anthracycline therapy.

29 Jul 2010

Onyx reports positive results from carfilzomib Phase 2b 003-A1 study in multiple myeloma

Onyx Pharmaceuticals, Inc. today announced positive top-line results from the Phase 2b 003-A1 study of single-agent carfilzomib, a selective, next generation proteasome inhibitor, in patients with relapsed and refractory multiple myeloma.

26 Jul 2010

Taiho Pharmaceutical receives approval to market ABRAXANE IV Infusion 100 mg in Japan

Abraxis BioScience, Inc., a fully integrated, global biotechnology company, today announced that Taiho Pharmaceutical Co., Ltd. has received approval from the Ministry of Health, Labor and Welfare to market ABRAXANE IV Infusion 100 mg, Paclitaxel Injection (Suspension with Albumin), for use in the treatment of breast cancer. The New Drug Application (J-NDA) for ABRAXANE was filed with the Ministry of Health, Labor and Welfare in 2008.

23 Jul 2010

Genentech disappointed with FDA ODAC's recommendation against Avastin

Genentech, Inc., a member of the Roche Group, announced today that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 12 to one that use of Avastin® (bevacizumab) in combination with paclitaxel for previously untreated (first-line) advanced HER2-negative breast cancer be removed from Avastin's U.S. label.

21 Jul 2010

CTI signs agreement with NerPharMa for long-term manufacture of pixantrone

Cell Therapeutics today announced that it has signed a manufacturing agreement with NerPharMa DS (a pharmaceutical manufacturing company belonging to Nerviano Medical Sciences S.r.l. for CTI's drug candidate pixantrone.

14 Jul 2010

Novelos reports positive results from NOV-002 Phase 2 neoadjuvant breast cancer trial

Novelos Therapeutics, Inc., a biopharmaceutical company developing therapeutics to treat cancer and hepatitis, today announced positive results in a Phase 2 trial of NOV-002 in combination with neoadjuvant chemotherapy treatment in patients with stage IIB-IIIC HER-2/neu negative invasive breast cancer, conducted by the Braman Family Breast Cancer Institute at Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine.

12 Jul 2010

FDA accepts to review sNDA for SPRYCEL for treating adult patients with CML

Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. today announced that the U.S. Food and Drug Administration has accepted for filing and review the supplemental New Drug Application for SPRYCEL (dasatinib) for the treatment of adult patients with newly diagnosed chronic myeloid leukemia in chronic phase.

12 Jul 2010

Genentech submits BLA for trastuzumab-DM1 in advanced HER2-positive breast cancer

Genentech, a member of the Roche Group, today announced that the company submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for trastuzumab-DM1 (T-DM1) in people with advanced HER2-positive breast cancer who have previously received multiple HER2-targeted medicines and chemotherapies.

7 Jul 2010

$CTI submits expanded PIP to EMEA for pixantrone MAA for relapsed or refractory, aggressive NHL$

CTI submits expanded PIP to EMEA for pixantrone MAA for relapsed or refractory, aggressive NHL

Cell Therapeutics, Inc. announced today that it has submitted an expanded Pediatric Investigation Plan to the European Medicines Agency, as part of the process for its submission for a Marketing Authorization Application for pixantrone in the E.U. for the treatment of relapsed or refractory, aggressive non-Hodgkin's lymphoma (NHL).

6 Jul 2010

Celgene signs definitive merger agreement to acquire Abraxis BioScience

Celgene Corporation and Abraxis BioScience Inc. today jointly announced the signing of a definitive merger agreement in which Celgene has agreed to acquire Abraxis BioScience. Under the terms of the merger agreement, each share of Abraxis BioScience common stock will be converted into the right to receive an upfront payment of $58.00 in cash and 0.2617 shares of Celgene common stock.

30 Jun 2010

Eribulin mesylate drug may help extend lives of women with advanced breast cancer

A new drug, based on a natural extract from sea sponge, may help to extend the lives of women with advanced breast cancer, UK scientists have found. A research team at the University of Leeds and St James's Institute of Oncology led an international trial of the new chemotherapy drug, eribulin mesylate.

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

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

Anthracycline News and Research

Impact of cancer treatment on cardiovascular function

FDA decides to review information on Avastin for advanced HER2-negative breast cancer

Cell Therapeutics to appeal FDA decision on pixantrone NDA for relapsed/refractory aggressive NHL

FDA denies accelerated approval of Genentech's trastuzumab-DM1 (T-DM1) BLA for metastatic breast cancer

CTI announces EMEA's validation of expanded PIP for pixantrone

CTI files SPA with FDA for new pixantrone phase III trial in relapsed or refractory aggressive B-Cell NHL

New Zealand MEDSAFE approves ABRAXANE for metastatic breast cancer

Onyx reports positive results from carfilzomib Phase 2b 003-A1 study in multiple myeloma

Taiho Pharmaceutical receives approval to market ABRAXANE IV Infusion 100 mg in Japan

Genentech disappointed with FDA ODAC's recommendation against Avastin

CTI signs agreement with NerPharMa for long-term manufacture of pixantrone

Novelos reports positive results from NOV-002 Phase 2 neoadjuvant breast cancer trial

FDA accepts to review sNDA for SPRYCEL for treating adult patients with CML

Genentech submits BLA for trastuzumab-DM1 in advanced HER2-positive breast cancer

CTI submits expanded PIP to EMEA for pixantrone MAA for relapsed or refractory, aggressive NHL

Celgene signs definitive merger agreement to acquire Abraxis BioScience

Eribulin mesylate drug may help extend lives of women with advanced breast cancer

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

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

Sensing a Healthier Future

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

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