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.

Rituxan's sBLA receives a Complete Response from the FDA

Genentech, Inc. a wholly-owned member of the Roche Group, and Biogen Idec announced today that the companies received a Complete Response from the U.S. Food and Drug Administration (FDA) for a supplemental Biologics License Application (sBLA) for Rituxan (rituximab) plus methotrexate (MTX) in patients with moderately-to-severely active rheumatoid arthritis (RA) who no longer respond to treatment with a disease modifying antirheumatic drug (DMARD), including MTX.

19 Oct 2009

Breast cancer patients who achieve pathological complete response have better outcomes

Locally advanced breast cancer patients who received the same class of neoadjuvant chemotherapy were found to have no evidence of disease at the time of their surgery, or achieved pathological complete response, at the same rate regardless of race, according to researchers at The University of Texas M. D. Anderson Cancer Center.

12 Oct 2009

Orphan drug designation for pixantrone applied by Cell Therapeutics

Cell Therapeutics, Inc. ("CTI") announced today that it has applied to the European Medicines Agency (EMEA) for orphan drug designation for pixantrone. CTI initiated the process of obtaining marketing approval in Europe in July, 2009, for the treatment of relapsed or refractory aggressive NHL.

30 Sep 2009

Genentech releases Phase III PRIMA study findings

Genentech, Inc., a wholly-owned member of the Roche Group and Biogen Idec, today announced that a Phase III study (PRIMA) showed that patients with follicular lymphoma who continued receiving Rituxan (rituximab) alone after responding to Rituxan and chemotherapy lived longer without their disease worsening (progression-free survival or PFS) than those who did not continue to receive Rituxan.

17 Sep 2009

Phase III EXTEND trial results of pixantrone announced

Cell Therapeutics, Inc. (CTI) today released updated 18-month follow-up clinical data for its phase III EXTEND (PIX 301) trial of pixantrone (BBR2778) for patients with advanced, relapsed or refractory, aggressive non-Hodgkin's lymphoma (NHL). Responses were evaluated by an Independent Assessment Panel that was blinded to patient assignment.

16 Sep 2009

Cell Therapeutics submits Pediatric Investigation Plan to EMEA for pixantrone

Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced today that it has submitted a Pediatric Investigation Plan (PIP) to the European Medicines Agency (EMEA) as part of the required filing process for approval of pixantrone for treating relapsed or refractory, aggressive non-Hodgkin's Lymphoma (NHL) in Europe. The PIP outlines how the company proposes to study the drug in children in order to benefit child health.

15 Sep 2009

Cytrx initiates tamibarotene and TRISENOX combination dose escalation study

CytRx Corporation (NASDAQ:CYTR), a biopharmaceutical company engaged in the development and commercialization of human therapeutics, today announced the initiation of a dose escalation study with its oncology drug candidate tamibarotene combined with TRISENOX® (arsenic trioxide) injection (marketed by Cephalon, Inc.) in patients with relapsed acute promyelocytic leukemia (APL).

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

FDA notifies PDUFA action date for Cell Therapeutics' NDA for pixantrone

Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced today that the U.S. Food and Drug Administration (FDA) has notified CTI that a Prescription Drug User Fee Act (PDUFA) action date of April 23, 2010 under standard review has been established regarding CTI's NDA for pixantrone as potential treatment for relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL).

5 Sep 2009

Chemotherapy affects sleep-wake activity rhythms of breast cancer patients

A study in the Sept.1 issue of the journal Sleep shows that the sleep-wake activity rhythms of breast cancer patients are impaired during the administration of chemotherapy. Results indicate that the first cycle of chemotherapy is associated with a temporary disruption of these rhythms, while repeated administration of chemotherapy results in progressively worse and more enduring impairments.

1 Sep 2009

Cell Therapeutics' NDA for Pixantrone accepted by the FDA

Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced today that the U.S. Food and Drug Administration (FDA) has accepted and has filed for review the Company's New Drug Application (NDA) for pixantrone as treatment for relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL). A Prescription Drug User Fee Act (PDUFA) date will be established by the FDA regarding the review of the pixantrone NDA by September 4th 2009.

24 Aug 2009

Genentech announces Phase III study results for Avastin (bevacizumab) in combination with chemo in HER2-negative breast cancer

Genentech, Inc. today announced that a Phase III study (RIBBON 2) of Avastin (bevacizumab) in combination with chemotherapy increased the time women with metastatic HER2-negative breast cancer whose initial chemotherapy had stopped working lived without the disease worsening (progression-free survival or PFS), compared to chemotherapy alone.

18 Aug 2009

U.S. District Court rules against Lilly regarding Gemzar patent

Eli Lilly and Company today announced that the U.S. District Court for the Eastern District of Michigan has granted a motion by Sun Pharmaceuticals for partial summary judgment.

17 Aug 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

Combining two chemotherapy drugs with Herceptin shows promise for metastatic HER2+ breast cancer

At the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO), researchers from the Mayo Clinic campus in Florida report that using a combination of capecitabine, vinorelbine, and trastuzumab offers a treatment option that is at least as beneficial as other current options - and doesn't cause hair loss in patients.

17 May 2009

Gene alterations associated with response to anthracycline therapy for breast cancer

Alterations in the topoisomerase II alpha (TOP2A) gene were associated with better patient outcomes following anthracycline-based therapy compared with non-anthracycline-based regimens, according to a study in the April 28 online issue of the Journal of the National Cancer Institute.

30 Apr 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

Researchers show how anthracycline class of chemotherapeutics block blood vessel growth, slow cancer spread

Researchers at the Johns Hopkins University School of Medicine have discovered how a whole class of commonly used chemotherapy drugs can block cancer growth.

21 Jan 2009

New research moves us one step closer to personalised breast cancer treatment

Cancer Research UK scientists have found that a test, already used in breast cancer diagnosis, can also predict who will and who won't benefit from commonly used chemotherapy drugs.

15 Dec 2008

Doxil and docetaxel combination treatment delays disease progression in metastatic breast cancer

Results from a Phase 3 study show that patients with metastatic breast cancer who were treated previously with an anthracycline in the adjuvant setting experienced a significant improvement in time to disease progression (TTP) and overall response rates after receiving a combination of DOXIL (doxorubicin HCl liposome injection) and docetaxel as compared to docetaxel alone.

14 Dec 2008