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Genentech confirms EMA, FDA updates on Avastin for metastatic breast cancer

Genentech, a member of the Roche Group, confirmed that following the reviews of Avastin® (bevacizumab) in metastatic breast cancer by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), the following regulatory announcements were made by the individual health authorities:

17 Dec 2010

Nektar reports positive results from NKTR-102 Phase 2 study in metastatic breast cancer at CTRC-AACR SABCS

Nektar Therapeutics today announced positive results from a Phase 2 clinical study evaluating single-agent NKTR-102 in patients with metastatic breast cancer during the 33rd Annual CTRC-AACR San Antonio Breast Cancer Symposium (SABCS). NKTR-102, a novel investigational topoisomerase I inhibitor-polymer conjugate, is Nektar's lead oncology candidate and is being evaluated in multiple cancer indications.

14 Dec 2010

Xeloda may reduce recurrence of faster growing breast cancers: Study

Joyce O'Shaughnessy, M.D., medical director and co-chair of the Breast Cancer Research Committee, US Oncology Research, and medical oncologist with Texas Oncology-Baylor Sammons Cancer Center, presented her study findings today at the 33rd Annual San Antonio Breast Cancer Symposium (SABCS), an international scientific symposium for interaction and exchange among basic scientists and clinicians in breast cancer

13 Dec 2010

Positive preliminary results from tivozanib-paclitaxel combination Phase 1b trial in metastatic breast cancer

AVEO Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced preliminary results from an ongoing Phase 1b clinical trial evaluating the company's lead product candidate, tivozanib, a highly potent and selective inhibitor of VEGF receptors 1, 2, and 3, in combination with paclitaxel (Taxol®), a standard chemotherapy regimen, in patients with metastatic breast cancer.

10 Dec 2010

AVEO to present data on tivozanib Phase 1b trial for breast cancer at SABCS Symposium

AVEO Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced that new clinical data from a Phase 1b trial evaluating the company's lead product candidate, tivozanib, a highly potent and selective inhibitor of VEGF receptors 1, 2, and 3, in combination with paclitaxel (Taxol), a standard chemotherapy regimen, will be presented during the 33rd Annual San Antonio Breast Cancer Symposium (SABCS) being held December 8-12, 2010 at the Henry B. Gonzalez Convention Center in San Antonio, Texas.

2 Dec 2010

AVEO announces results from tivozanib Phase 1b clinical trial for advanced gastrointestinal cancers

AVEO Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced results from a Phase 1b clinical trial evaluating the company's lead product candidate, tivozanib, a highly potent and selective inhibitor of VEGF receptors 1, 2, and 3, in combination with FOLFOX6, a standard chemotherapy regimen, in patients with advanced gastrointestinal (GI) cancers.

19 Nov 2010

AVEO commences enrollment in Phase 1b combination trial of tivozanib with oral capecitabine in advanced tumors

AVEO Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced that it has initiated patient enrollment in an open-label, multi-center Phase 1b clinical trial evaluating tivozanib in combination with oral capecitabine (Xeloda®) in patients with certain advanced solid tumors.

17 Nov 2010

FDA approves Halaven therapy for metastatic late-stage breast cancer

The U.S. Food and Drug Administration today approved Halaven (eribulin mesylate) to treat patients with metastatic breast cancer who have received at least two prior chemotherapy regimens for late-stage disease.

16 Nov 2010

FDA approves Herceptin with chemotherapy for HER2-positive metastatic cancer

Genentech, a member of the Roche Group today announced the U.S. Food and Drug Administration (FDA) has approved Herceptin (trastuzumab) in combination with chemotherapy (cisplatin plus either capecitabine or 5-fluorouracil [5-FU]) for HER2-positive metastatic (cancer that has spread) cancer of the stomach or gastroesophageal junction, in men and women who have not received prior medicines for their metastatic disease.

21 Oct 2010

ACT Biotech reports positive interim data from Telatinib Phase 2 trial for advanced gastric cancer

ACT Biotech Inc., a privately held biotechnology company based in San Francisco, California, today announced positive interim data from a Phase 2 trial of the Company's lead oral kinase inhibitor, Telatinib, for the first-line treatment of patients with advanced gastric cancer. This proof-of-concept, multi-center, open label trial was designed to test the efficacy and safety of full-dose Telatinib, administered continuously, as a first-line treatment in combination with a standard regimen of capecitabine and cisplatin in US and European patients.

11 Oct 2010

Study: Capecitabine with concurrent radiation is effective for treating gastric cancer

Gastric cancer is a major cause of cancer deaths in the world. The outcome of large gastric tumors and those with lymph node involvement remains poor after surgical resection. The optimal adjuvant therapy after surgical resection remains to be determined.

21 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

Genentech receives FDA Refuse to File letter for accelerated approval of trastuzumab-DM1 BLA

ImmunoGen, Inc., a biotechnology company that develops antibody-based targeted anticancer products, today announced that Genentech, a member of the Roche Group, today announced its receipt of a Refuse to File (RTF) letter from the US Food and Drug Administration (FDA) for the accelerated approval of the Biologic License Application (BLA) for trastuzumab-DM1, or T-DM1, submitted in July 2010.

27 Aug 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

NICE draft guidance rejects cancer drug bevacizumab

The National Institute for Health and Clinical Excellence (NICE) has released draft guidance for cancer drug bevacizumab (Avastin).

25 Aug 2010

Aeterna Zentaris second-quarter revenues decrease to $5.6 million

Aeterna Zentaris Inc., a late-stage drug development company specialized in oncology and endocrinology, today reported financial and operating results for the second quarter ended June 30, 2010.

12 Aug 2010

Array BioPharma fiscal 2010 revenue increases to $53.9 million

Array BioPharma Inc. today reported financial results for the fourth quarter and full year of fiscal 2010.

10 Aug 2010

Health Canada approves first targeted biological therapy to show survival benefit in stomach cancer

Roche announced today that after priority review, Health Canada has approved HERCEPTIN(R) (trastuzumab), in combination with XELODA(R) (capecitabine) or intravenous 5-fluorouracil and cisplatin, for the first-line treatment of patients with HER2-positive metastatic adenocarcinoma of the stomach (gastric cancer) or gastro-esophageal cancer.

9 Aug 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

Interim progress from Phase III TeloVac study of GV1001 vaccine announced

KAEL-GemVax, a leading oncology vaccine company, today announced, through its subsidiary GemVax A.S, encouraging interim progress from the UK-based Phase III TeloVac study of its anti-telomerase therapeutic cancer vaccine GV1001 in pancreatic cancer. The company also strongly believes GV1001 has major "blockbuster" potential as a universal therapeutic cancer vaccine and is developing a strong pipeline for other indications, including lung and liver cancer and melanoma.

12 Jul 2010