Dacarbazine News and Research

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FDA approves Yondelis (trabectedin) for treatment of specific soft tissue sarcomas

The U.S. Food and Drug Administration today approved Yondelis (trabectedin), a chemotherapy, for the treatment of specific soft tissue sarcomas (STS) – liposarcoma and leiomyosarcoma – that cannot be removed by surgery (unresectable) or is advanced (metastatic).

24 Oct 2015

Array Biopharma reports strong fourth quarter and full year 2015 financial results

Array BioPharma Inc. today reported results for the fourth quarter and full year of its fiscal year ended June 30, 2015.

3 Aug 2015

Phase 3 SUMIT study: Selumetinib fails to meet primary endpoint in patients with metastatic uveal melanoma

AstraZeneca today announced that the Phase 3 SUMIT study of selumetinib in combination with dacarbazine for the treatment of patients with metastatic uveal melanoma did not meet its primary endpoint of progression free survival. This combination therapy showed an adverse event profile generally consistent with current knowledge of the safety profiles of dacarbazine and selumetinib.

23 Jul 2015

Trabectedin may be better than dacarbazine for treatment of soft tissue sarcoma

Janssen Research & Development, LLC announced data from the Phase 3 multicenter study SAR3007, which demonstrated a significant improvement in progression-free survival with trabectedin (YONDELIS®) compared to dacarbazine in patients with advanced liposarcoma (LPS) or leiomyosarcoma (LMS) previously treated with an anthracycline and at least one additional chemotherapy regimen.

2 Jun 2015

Eisai Phase 3 trial of eribulin meets primary endpoint in patients with advanced soft tissue sarcoma

Eisai Inc. announced today the results of its Phase 3 trial (Study 309), which showed that eribulin met the study's primary endpoint evaluating overall survival in patients who had advanced leiomyosarcoma (LMS) or adipocytic sarcoma (ADI), two types of advanced soft tissue sarcoma.

30 May 2015

Array BioPharma presents clinical data of BRAF, MEK and HER2 drugs at 2015 ASCO Annual Meeting

Array BioPharma Inc. today announced presentations on encorafenib, binimetinib and selumetinib (licensed to AstraZeneca) at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting, which will be held May 29 – June 2, 2015 in Chicago, Illinois.

29 May 2015

Combination of anti-Nodal and DTIC therapy can produce anti-cancer effects

Metastatic melanoma is the leading cause of skin cancer deaths in the United States; once melanoma has spread (metastasized), life expectancy for patients can be dramatically shortened.

13 Mar 2015

Janssen granted Priority Review from FDA for YONDELIS (trabectedin) NDA to treat STS patients

Janssen Research & Development, LLC announced today that the U.S. Food and Drug Administration has granted Priority Review for the New Drug Application (NDA) for YONDELIS (trabectedin) to treat patients with advanced soft tissue sarcoma (STS), including liposarcoma and leiomyosarcoma subtypes, who have received prior chemotherapy including an anthracycline.

3 Feb 2015

Pre-clinical studies confirm TRXE-009 as new potential treatment for melanoma

Novogen Limited, Australian/US biotechnology company, today announces that it has confirmed that its lead candidate product, TRXE-009, originally developed for the treatment of brain cancers, has been shown in pre-clinical studies also to be highly active against melanoma.

16 Dec 2014

Janssen submits YONDELIS NDA for treatment of advanced soft tissue sarcoma

PharmaMar announces that Janssen Research & Development, LLC has submitted a New Drug Application (NDA) for YONDELIS (trabectedin) to the U.S. Food and Drug Administration for the treatment of patients with advanced soft tissue sarcoma (STS), including liposarcoma and leiomyosarcoma subtypes, who have received prior chemotherapy including an anthracycline.

26 Nov 2014

GSK reports 45% survival rate in phase III study of Tafinlar in BRAF V600E mutant metastatic melanoma

GSK today announced updated results for Tafinlar (dabrafenib) from a planned analysis of the phase III BREAK-3 study in 250 patients with BRAF V600E mutant metastatic melanoma.

30 Sep 2014

Nivolumab drug achieves superior response rates in previously-treated advanced melanoma patients

The monoclonal antibody nivolumab achieves superior response rates and a longer duration of response than standard chemotherapy in patients whose melanoma has progressed after treatment with ipilimumab, according to phase III data presented at the ESMO 2014 Congress in Madrid, Spain.

30 Sep 2014

Study compares effectiveness of selumetinib, chemotherapy in patients with advanced uveal melanoma

In patients with advanced uveal melanoma, treatment with the agent selumetinib, compared with chemotherapy, resulted in an improved cancer progression-free survival time and tumor response rate, but no improvement in overall survival, according to a study in the June 18 issue of JAMA. The modest improvement in clinical outcomes was accompanied by a high rate of adverse events.

18 Jun 2014

Study shows dabrafenib has no added benefit in comparison with dacarbazine

Dabrafenib (trade name: Tafinlar) has been approved since August 2013 for the treatment of advanced melanoma. In January 2014, in an early benefit assessment pursuant to the "Act on the Reform of the Market for Medicinal Products" (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) had determined that dabrafenib has no added benefit in comparison with dacarbazine.

10 Apr 2014

CytRx initiates Phase 3 clinical trial to evaluate efficacy of aldoxorubicin in STS patients

CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical research and development company specializing in oncology, today announced it has initiated a pivotal global Phase 3 clinical trial to evaluate the efficacy and safety of aldoxorubicin as a second-line treatment for patients with soft tissue sarcoma (STS) under a Special Protocol Assessment with the FDA.

25 Mar 2014

Added benefit of ipilimumab in advanced melanoma not proven for non-pretreated patients

The German Institute for Quality and Efficiency in Health Care already assessed the added benefit of ipilimumab in advanced melanoma in 2012. A considerable added benefit was found for patients who had already received previous treatment. In the new dossier compiled by the drug manufacturer, the drug was now compared with the appropriate comparator therapy dacarbazine specified by the Federal Joint Committee (G-BA) also for non-pretreated patients.

19 Mar 2014

CytRx receives FDA approval to continue dosing aldoxorubicin for patients with soft tissue sarcomas

CytRx Corporation (NASDAQ:CYTR), a biopharmaceutical research and development company specializing in oncology, today announced it has received approval from the U.S. Food and Drug Administration (FDA) to continue dosing patients with aldoxorubicin until disease progression in a planned pivotal, global Phase 3 clinical trial with aldoxorubicin as a second-line treatment for soft tissue sarcomas.

22 Jan 2014

Added benefit of dabrafenib not proven

Dabrafenib has been approved in Germany since August 2013 for the treatment of advanced melanoma. In an early benefit assessment pursuant to the Act on the Reform of the Market for Medicinal Products, the German Institute for Quality and Efficiency in Health Care examined whether this new drug offers an added benefit over the appropriate comparator therapy.

7 Jan 2014

IQWiG reassesses vemurafenib for treatment of advanced melanoma

Pursuant to the Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) reassessed vemurafenib (trade name: Zelboraf), a drug for the treatment of adults with a certain type of advanced melanoma.

20 Dec 2013

New hope for patients whose melanoma has metastasised to the brain

New data show that in patients whose melanoma (BRAF V600 mutation-positive) has spread (metastasised) to the brain, Zelboraf (vemurafenib) extends life expectancy by over six months compared to chemotherapy.1 These results are welcome news for patients suffering from metastatic melanoma, as up to half of these patients are diagnosed with brain metastases with many given less than six months to live.1

18 Nov 2013