Docetaxel News and Research

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Docetaxel is approved by the Food and Drug Administration (FDA) to be used alone or with other drugs to treat certain types of breast and non-small cell lung cancer (NSCLC). It is also approved to be used with other drugs to treat squamous cell carcinoma of the head and neck (SCCHN) and certain types of gastric and prostate cancer.

Docetaxel is a semi-synthetic, second-generation taxane derived from a compound found in the European yew tree Taxus baccata. Docetaxel displays potent and broad antineoplastic properties; it binds to and stabilizes tubulin, thereby inhibiting microtubule disassembly which results in cell- cycle arrest at the G2/M phase and cell death. This agent also inhibits pro-angiogenic factors such as vascular endothelial growth factor (VEGF) and displays immunomodulatory and pro-inflammatory properties by inducing various mediators of the inflammatory response. Docetaxel has been studied for use as a radiation-sensitizing agent.

Anti-HER2 antibody-drug conjugate effective as first-line therapy for advanced breast cancer: Research

A new type of breast cancer treatment has shown encouraging activity as a first-line therapy in HER2-positive metastatic disease, researchers reported at the 35th Congress of the European Society for Medical Oncology (ESMO) in Milan, Italy.

11 Oct 2010

Sanofi-aventis publishes Phase III TROPIC study data in The Lancet article

Sanofi-aventis announced today that data from the Phase III TROPIC study, which was the basis for the June 2010 U.S. Food and Drug Administration (FDA) approval of Jevtana (cabazitaxel) Injection, was published in the October 2, 2010 print edition of The Lancet in an article titled "Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial.

4 Oct 2010

Array BioPharma to present positive interim results of Phase 1 ARRY-380 trial at ASCO Symposium

Array BioPharma Inc. today announced positive interim results of its novel, oral HER2 (ErbB2) inhibitor, ARRY-380, in a Phase 1 trial in patients with advanced cancer.

4 Oct 2010

Teva Pharmaceuticals, OncoGenex initiate SYNERGY Phase 3 trial to evaluate custirsen

Teva Pharmaceuticals Industries Ltd. and OncoGenex Pharmaceuticals, Inc. announced today the initiation of SYNERGY, a global Phase 3 trial evaluating custirsen (also known as OGX-011/TV-1011) as first line therapy for the treatment of castrate-resistant prostate cancer (CRPC).

30 Sep 2010

Pfizer ceases SUN 1120 Phase 3 trial of SUTENT in men with CRPC

Pfizer Inc. announced today the discontinuation of the SUN 1120 Phase 3 trial evaluating SUTENT (sunitinib malate) in combination with prednisone for men with advanced castration-resistant prostate cancer that had progressed despite treatment with a docetaxel-based chemotherapy regimen. During a scheduled interim analysis, an independent Data Monitoring Committee found that the combination of sunitinib with prednisone was unlikely to improve overall survival when compared to prednisone alone.

28 Sep 2010

Hospira's Nivestim receives Australian TGA approval

Hospira, Inc., the world leader in generic injectable pharmaceuticals, today announced that it has received Australian Therapeutic Goods Administration approval for its biosimilar filgrastim product, Nivestim.

27 Sep 2010

Genta commences new tesetaxel Phase 2 clinical trial in advanced bladder cancer

Genta Incorporated today announced that the Company has initiated a new Phase 2 clinical trial of tesetaxel in patients with advanced bladder cancer. Tesetaxel is the leading oral taxane in clinical development. The new trial will be conducted at Memorial Sloan-Kettering Cancer Center, New York, NY, the Kimmel Cancer Center at Jefferson University, Philadelphia, PA, and at least one site in the EU.

24 Sep 2010

Results of custirsen Phase 2 trial for advanced prostate cancer published in Journal of Clinical Oncology

OncoGenex Pharmaceuticals, Inc. announced today publication of results from a randomized Phase 2 trial in the Journal of Clinical Oncology. The trial results showed a survival benefit with the investigational agent OGX-011/TV1011 (custirsen) in patients with advanced prostate cancer. The median overall survival for patients who were treated with custirsen plus first-line docetaxel/prednisone was 23.8 months compared to 16.9 months for patients treated with docetaxel/prednisone alone.

22 Sep 2010

Synta expands STA-9090 Phase 2 clinical trial in NSCLC

Synta Pharmaceuticals Corp., a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, today announced that it was expanding its Phase 2 clinical trial of STA-9090 in patients with Stage IIIB and Stage IV non-small cell lung cancer (NSCLC) from up to 69 patients to up to 146 patients based on encouraging activity observed in the first stage of the two stage clinical trial.

13 Sep 2010

Ortho Biotech unblinded abiraterone acetate Phase 3 study for prostate cancer patients

Ortho Biotech Oncology Research & Development, a unit of Cougar Biotechnology, Inc., today announced that it has unblinded the Phase 3 study of abiraterone acetate plus prednisone for the treatment of patients with metastatic advanced prostate cancer (also referred to as castration-resistant prostate cancer) whose disease has progressed following treatment with one or two chemotherapy regimens at least one of which contained docetaxel.

10 Sep 2010

Aflibercept Phase 3 VELOUR clinical trial for mCRC to continue to completion

Sanofi-aventis and Regeneron Pharmaceuticals, Inc. announced that the Phase 3 VELOUR clinical trial of aflibercept (VEGF Trap) in patients with metastatic colorectal cancer (mCRC) will continue to completion as planned, with no modifications due to efficacy or safety concerns. This decision is based on the recommendation of an Independent Data Monitoring Committee (IDMC) following a planned interim analysis.

9 Sep 2010

In vitro HDRA improves survival, prognosis of patients with NSCLC: Study

Chemotherapy is the best broad defense against cancer recurrence after surgical resection. However, it is difficult to predict which patients will benefit from which regimen of anticancer drugs, if at all. Building on existing knowledge, a study published in the September edition of the Journal of Thoracic Oncology, analyzed the usefulness of adjuvant chemotherapy for non-small cell lung cancer based on the histoculture drug response assay.

2 Sep 2010

Celator Pharmaceuticals raises $20 million in Series D private equity financing

Celator Pharmaceuticals, a privately held pharmaceutical company developing new and more effective therapies to treat cancer based on the company's proprietary technology, today announced that it raised $20 million in a Series D private equity financing.

2 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

Phase 1 CRLX101 clinical study paves way for promising innovations in cancer therapy: Cerulean Pharma

Cerulean Pharma Inc., a leader in designing and developing nanopharmaceuticals, today announced that results of a Phase 1 clinical study of CRLX101 (formerly IT-101), Cerulean's lead clinical development candidate, and pre-clinical data on Cerulean's development candidate, CRLX288, were presented at the American Chemical Society National Meeting & Exposition, ongoing in Boston, Massachusetts.

26 Aug 2010

First patient treated in Synta Pharmaceuticals' clinical trial of STA-9090

Synta Pharmaceuticals Corp., a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, today announced that the first patient has been treated in its clinical trial of STA-9090 in combination with docetaxel for the treatment of advanced solid tumor malignancies.

24 Aug 2010

Preclinical studies of BIND-014 to be presented at ACS National Meeting

BIND Biosciences announced today the presentation of its Medicinal Nanoengineering platform at the ACS National Meeting, including results from preclinical studies on its lead nanomedicine drug , BIND-014, scheduled to enter clinical trials later this year. BIND-014 is a targeted, polymeric nanoparticle containing the cytotoxic agent, docetaxel, which is approved in major cancer indications, including breast, prostate and lung.

23 Aug 2010

Docetaxel News and Research

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