Capecitabine News and Research

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Two Phase 3 studies of Sutent in advanced breast cancer fail to meet primary endpoints

Pfizer Inc. announced today that two Phase 3 studies of Sutent® (sunitinib malate) in advanced breast cancer did not meet their primary endpoints. The SUN 1064 Phase 3 study of sunitinib in combination with docetaxel for the first-line treatment of patients with advanced HER-2 negative breast cancer did not show a statistically significant improvement in progression-free survival compared with docetaxel alone.

12 Mar 2010

Herceptin as add-on to standard chemotherapy for gastric cancer earns Decision Resources' gold standard status

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, for the treatment of gastric cancer, Roche/Genentech/ Chugai's Herceptin as an add-on to standard chemotherapy earns Decision Resources' proprietary clinical gold standard status in 2013, following its approval for the first-line treatment of human epidermal growth factor receptor 2 (HER2)-positive gastric cancer in 2010.

9 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

CINJ researchers test malaria drug for colorectal cancer treatment

While new cases of colorectal cancer continue to decline in the United States, it remains the third leading cause of cancer death in the nation, according to the American Cancer Society. That is why researchers at The Cancer Institute of New Jersey are looking to add a drug known for fighting malaria to traditional chemotherapy for colorectal cancer to see if treatment can be made more effective for patients.

23 Feb 2010

Keryx Biopharmaceuticals reaches agreement with FDA on SPA for Phase 3 trial of KRX-0401

Keryx Biopharmaceuticals, Inc. announced today that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of a Phase 3 trial for its PI3K/Akt pathway inhibitor, KRX-0401 (perifosine), in patients with refractory metastatic colorectal cancer.

3 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

Genentech announces Phase III study of Avastin in women treated with chemotherapy for advanced breast cancer

Genentech, Inc., a wholly owned member of the Roche Group, today announced results from a Phase III study (RIBBON 2) of Avastin® (bevacizumab) in women who had previously been treated with initial (first-line) chemotherapy for advanced HER2-negative breast cancer and needed additional (second-line) treatment.

14 Dec 2009

CTRC-AACR San Antonio Breast Cancer Symposium presents new data on emerging breast cancer therapies

Breast cancer continues to be a dynamic field of research, and the CTRC-AACR San Antonio Breast Cancer Symposium, now in its 32nd year, is the premier destination to present new data on emerging therapies.

14 Dec 2009

Pfizer announces results from studies evaluating neratinib

Pfizer Inc. today announced results from studies evaluating neratinib (HKI-272), an investigational, orally administered, pan-ErbB inhibitor, in patients with human epidermal growth factor receptor-2 (HER2, also known as ErbB2) positive breast cancer at the 2009 CTRC-AACR San Antonio Breast Cancer Symposium (SABCS).

14 Dec 2009

Results from Phase 2 trial evaluating Nexavar with capecitabine and paclitaxel presented

Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. today announced results from two collaborative group-sponsored randomized, double-blind, placebo-controlled Phase 2 trials were presented at the 32nd Annual San Antonio Breast Cancer Symposium (SABCS).

14 Dec 2009

Combination therapy improves overall survival in women with advanced breast cancer

In a clinical study, women with an aggressive form of breast cancer experienced a median survival of 14 months when treated with an investigational combination of TYKERB® (lapatinib) plus HERCEPTIN® (trastuzumab). The results of the Phase III study in HER2-positive metastatic breast cancer were presented during the 32nd Annual CTRC-AACR San Antonio Breast Cancer Symposium, held in San Antonio, Texas (Dec. 9 - 13).

14 Dec 2009

Genentech announces positive results from Phase II study of T-DM1

Genentech, Inc., a wholly owned member of the Roche Group, today announced positive results from a Phase II study of trastuzumab-DM1 (T-DM1). As assessed by independent review, T-DM1 shrank the tumors (also known as objective response) in 33 percent of women with advanced (metastatic) HER2-positive breast cancer that had worsened following previous treatment.

14 Dec 2009

ImmunoGen announces the presentation of positive trastuzumab-DM1 clinical data

ImmunoGen, Inc., a biopharmaceutical company that develops targeted anticancer therapeutics, today announced the presentation of positive trastuzumab-DM1 (T-DM1) clinical data at the 32nd Annual San Antonio Breast Cancer Symposium (Abstract #710).

14 Dec 2009

Pfizer to present study findings from its expanded breast cancer portfolio

Pfizer Oncology announced today that it will be presenting study findings evaluating several compounds including those from its newly expanded breast cancer portfolio following the recent acquisition of Wyeth, focusing on the needs of multiple breast cancer patient populations at the CTRC-AACR San Antonio Breast Cancer Symposium (SABCS) being held December 9 – 13.

4 Dec 2009

Genentech submits sBLAs to the FDA for Avastin

Genentech, Inc., a wholly-owned member of the Roche Group, today announced that the company submitted two supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA) for Avastin® (bevacizumab) for the treatment of women who have not received chemotherapy for advanced (metastatic) HER2-negative breast cancer (first-line treatment). One sBLA is based on the Phase III study AVADO that investigated Avastin in combination with docetaxel chemotherapy.

17 Nov 2009

Capecitabine in chemotherapy regimen reduces early breast cancer recurrence

An analysis conducted by the Finnish Breast Cancer Group and published in The Lancet Oncology shows women at intermediate to high-risk of early breast cancer recurrence who received capecitabine as part of their chemotherapy regimen had a 34% reduction in the risk of the disease returning or death, compared with those taking the chemotherapy combination regimen without capecitabine.

11 Nov 2009

Positive interim data from the multicenter randomized Phase II trial of palifosfamide presented

ZIOPHARM Oncology, Inc. presented today at the 15th Annual Connective Tissue Oncology Society (CTOS) Meeting, positive interim data from the multicenter randomized Phase II trial of palifosfamide (ZymafosTM, ZIO-201) treating patients with unresectable or metastatic soft tissue sarcoma.

6 Nov 2009

Bristol-Myers Squibb reports strong sales and earnings growth for third quarter 2009

Bristol-Myers Squibb Company today reported strong sales and earnings growth for the third quarter 2009.

22 Oct 2009

Positive data from ZIOPHARM's palifosfamide sarcoma Phase II trial

ZIOPHARM Oncology, Inc. announced today positive top line interim data from the multicenter randomized Phase II trial of palifosfamide (ZymafosTM, ZIO-201) treating patients with unresectable or metastatic soft tissue sarcoma. The analysis evaluated 62 patients treated as of the end of September, with 58 being analyzed.

14 Oct 2009

Capecitabine News and Research

Two Phase 3 studies of Sutent in advanced breast cancer fail to meet primary endpoints

Herceptin as add-on to standard chemotherapy for gastric cancer earns Decision Resources' gold standard status

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

CINJ researchers test malaria drug for colorectal cancer treatment

Keryx Biopharmaceuticals reaches agreement with FDA on SPA for Phase 3 trial of KRX-0401

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

FDA grants accelerated approval for GlaxoSmithKline's TYKERB

Genentech announces Phase III study of Avastin in women treated with chemotherapy for advanced breast cancer

CTRC-AACR San Antonio Breast Cancer Symposium presents new data on emerging breast cancer therapies

Pfizer announces results from studies evaluating neratinib

Results from Phase 2 trial evaluating Nexavar with capecitabine and paclitaxel presented

Combination therapy improves overall survival in women with advanced breast cancer

Genentech announces positive results from Phase II study of T-DM1

ImmunoGen announces the presentation of positive trastuzumab-DM1 clinical data

Pfizer to present study findings from its expanded breast cancer portfolio

Genentech submits sBLAs to the FDA for Avastin

Capecitabine in chemotherapy regimen reduces early breast cancer recurrence

Positive interim data from the multicenter randomized Phase II trial of palifosfamide presented

Bristol-Myers Squibb reports strong sales and earnings growth for third quarter 2009

Positive data from ZIOPHARM's palifosfamide sarcoma Phase II trial

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