Capecitabine News and Research

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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NICE draft guidance rejects cancer drug bevacizumab

The National Institute for Health and Clinical Excellence (NICE) has released draft guidance for cancer drug bevacizumab (Avastin).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

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

EMA grants Scientific Advice to Aeterna Zentaris for Phase 3 trial of anticancer compound perifosine

Aeterna Zentaris Inc., a late-stage drug development company specialized in oncology and endocrine therapy, today announced that it has received positive Scientific Advice from the European Medicines Agency (EMA) regarding the Phase 3 trial initiated last April for the development of its lead anticancer proprietary compound, perifosine, in refractory advanced colorectal cancer.

30 Jun 2010

Ph II data of perifosine + capecitabine in metastatic CRC to be presented at gastrointestinal cancer congress

Keryx Biopharmaceuticals, Inc. today announced that abstract O-0017, entitled "Subset Analysis of 5-FU Refractory Patients from a Randomized Ph II Study of Perifosine + Capecitabine (P-CAP) vs. Placebo + Capecitabine (CAP) in Patients with 2nd or 3rd Line Metastatic CRC" has been selected for oral presentation at the upcoming 12th World Congress on Gastrointestinal Cancer, to be held in Barcelona, Spain from June 30 - July 2, 2010.

30 Jun 2010

Aeterna Zentaris receives positive Scientific Advice from EMA for perifosine Phase 3 trial in colorectal cancer

29 Jun 2010

New presentations on neuroendocrine tumors at ESMO 12th World Congress on Gastrointestinal Cancer

Groundbreaking studies will be presented at the ESMO 12th World Congress on Gastrointestinal Cancer next week in Barcelona, Spain, including exciting new data on treatment for neuroendocrine tumors. "The presentations this year are very significant for clinicians, and outline real progress in the development of agents that are effective in managing and treating gastrointestinal diseases," says Eric Van Cutsem, MD, PhD of the University Hospital Gasthuisberg in Leuven, Belgium and Congress co-chair.

23 Jun 2010

ZIOPHARM Oncology announces guidance on palifosfamide Phase III trial in metastatic soft tissue sarcoma

ZIOPHARM Oncology, Inc. announced guidance today regarding the Company's planned pivotal Phase III trial for palifosfamide in metastatic soft tissue sarcoma, including details of the proposed study's design, timing and regulatory review.

21 Jun 2010

Aeterna Zentaris reports final results on clinical activity of perifosine for metastatic colorectal cancer

Aeterna Zentaris Inc., a late-stage drug development company specialized in oncology and endocrine therapy, today reported final results on the clinical activity of perifosine (KRX-0401), the Company's novel, potentially first-in-class, oral anticancer agent that inhibits Akt activation in the phosphoinositide 3-kinase pathway, in combination with capecitabine (Xeloda) as a treatment for advanced, metastatic colorectal cancer.

10 Jun 2010

NICE decides not to recommend lapatinib for women with advanced breast cancer

The National Institute for Health and Clinical Excellence has decided not to recommend the oral drug lapatinib (Tyverb) for women with advanced breast cancer, except for use in clinical trials.

10 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

Multiple presentations on nab-driven chemotherapy at 46th ASCO

Abraxis BioScience, Inc. presented abstracts describing 10 trials of nanoparticle albumin bound (nab®) driven chemotherapy, nab-paclitaxel (ABRAXANE® for Injectable Suspension; paclitaxel albumin protein-bound particles for injectable suspension), for the treatment of breast cancer at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago.

9 Jun 2010

Capecitabine News and Research

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

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

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

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

NICE draft guidance rejects cancer drug bevacizumab

Aeterna Zentaris second-quarter revenues decrease to $5.6 million

Array BioPharma fiscal 2010 revenue increases to $53.9 million

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

Genentech disappointed with FDA ODAC's recommendation against Avastin

Interim progress from Phase III TeloVac study of GV1001 vaccine announced

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

EMA grants Scientific Advice to Aeterna Zentaris for Phase 3 trial of anticancer compound perifosine

Ph II data of perifosine + capecitabine in metastatic CRC to be presented at gastrointestinal cancer congress

Aeterna Zentaris receives positive Scientific Advice from EMA for perifosine Phase 3 trial in colorectal cancer

New presentations on neuroendocrine tumors at ESMO 12th World Congress on Gastrointestinal Cancer

ZIOPHARM Oncology announces guidance on palifosfamide Phase III trial in metastatic soft tissue sarcoma

Aeterna Zentaris reports final results on clinical activity of perifosine for metastatic colorectal cancer

NICE decides not to recommend lapatinib for women with advanced breast cancer

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

Multiple presentations on nab-driven chemotherapy at 46th ASCO

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