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Genentech submits vemurafenib NDA for BRAF V600 mutation-positive metastatic melanoma

Genentech, a member of the Roche Group, today announced that the company submitted a New Drug Application for vemurafenib to the U.S. Food and Drug Administration for people with BRAF V600 mutation-positive metastatic melanoma, and that Roche submitted a Marketing Authorization Application to the European Medicines Agency for vemurafenib in the same indication.

11 May 2011

Plexxikon seeks vemurafenib marketing approval from FDA and EMA for melanoma treatment

Plexxikon Inc., a member of the Daiichi Sankyo Group, today announced that applications for market approval for vemurafenib for the treatment of metastatic melanoma have been submitted to the U.S. Food and Drug Administration and the European Medicines Agency.

11 May 2011

FDA approves ipilimumab for metastatic melanoma treatment

The U.S. Food and Drug Administration announced today its approval of a new treatment for advanced melanoma, the deadliest and most difficult-to-treat form of skin cancer.

28 Mar 2011

BMY receives FDA approval for YERVOY to treat metastatic melanoma

Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration approved YERVOY 3 mg/kg for the treatment of patients with unresectable or metastatic melanoma.

28 Mar 2011

BMY's ipilimumab Phase III study against metastatic melanoma meets primary endpoint

Bristol-Myers Squibb Company today announced that a clinical trial -- known as study 024 -- of its investigational compound ipilimumab has met the primary endpoint of improving overall survival in previously-untreated patients with metastatic melanoma.

22 Mar 2011

Daiichi Sankyo enters merger agreement to acquire Plexxikon

Plexxikon Inc. today announced it has entered into a merger agreement with Daiichi Sankyo Company, Limited, a Japan-based global pharmaceutical company.

28 Feb 2011

Independent Safety Monitoring Board recommends Vical's Allovectin-7 Phase 3 trial to continue as per protocol

Vical Incorporated today announced that an independent Safety Monitoring Board (SMB) for the company's Phase 3 trial of Allovectin-7® in patients with metastatic melanoma has completed the trial's fifth scheduled safety analysis and recommended that the trial continue per the protocol.

14 Feb 2011

RG7204 Phase III study shows significant survival benefit in patients with metastatic melanoma

Genentech, a member of the Roche Group, today announced that BRIM3, a Phase III clinical study of RG7204, met its co-primary endpoints showing a significant survival benefit in people with previously untreated BRAF V600 mutation-positive metastatic melanoma.

19 Jan 2011

Positive results from PLX4032 Phase 3 Trial in patients with metastatic melanoma

Plexxikon today announced positive data from an interim analysis of the BRIM3 trial, a large multi-center Phase 3 clinical study of PLX4032 in patients with previously untreated metastatic melanoma with the BRAF mutation. Patients treated with PLX4032 had an improved overall survival compared to patients treated with dacarbazine, the current standard of care.

19 Jan 2011

Positive results from Allovectin-7 Phase 3 trial in patients with metastatic melanoma

Vical Incorporated today announced a new publication summarizing results from the company's completed trials of Allovectin-7 including systemic responses and an excellent safety profile in patients with metastatic melanoma.

11 Jan 2011

Research reveals new standard treatment options for various forms of lymphoma

The next generation of drug therapies and enhanced treatment approaches for various forms of lymphoma are evolving as researchers continue to better understand how these cancers progress. Research will be presented today at the 52nd Annual Meeting of the American Society of Hematology introducing promising new options for the standard treatment of advanced asymptomatic follicular lymphoma, mantle cell lymphoma, and early, unfavorable (referring to patients with clinical stage I or II disease and one or more risk factors) Hodgkin disease.

6 Dec 2010

Rush University enrolls first U.S. patient in international clinical trial for melanoma

Rush University Medical Center has just enrolled the first U.S. patient in an international clinical trial testing a novel drug to treat certain kinds of melanoma, a deadly skin cancer that in its advanced stages currently has few effective treatments.

1 Dec 2010

Promising skin cancer drug in the near horizon

A new drug has been developed to combat a deadly form of skin cancer – melanoma. The drug, PLX4032, was tested on 32 melanoma patients who had a key mutation in their tumors. 26 of these patients responded favorably says the study published in the New England Journal of Medicine.

30 Aug 2010

Treating metastatic melanoma tumors with specific genetic signature shows promising results

Use of an experimental targeted drug to treat metastatic melanoma tumors with a specific genetic signature was successful in more than 80 percent of patients in a phase 1 clinical trial.

26 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

ZymoGenetics second-quarter net loss declines to $3.8 million

ZymoGenetics, Inc. today reported substantially improved financial results for the quarter ended June 30, 2010. For the second quarter of 2010, the company's net loss declined to $3.8 million, or $0.04 per share, a $23.2 million improvement from the $27.0 million loss, or $0.39 per share, reported for the second quarter of 2009. The improvement resulted from higher revenues as well as reduced operating expenses.

4 Aug 2010

Independent SMB recommends continuance of Allovectin-7 Phase 3 trial for metastatic melanoma

Vical Incorporated today announced that an independent Safety Monitoring Board (SMB) for the company's Phase 3 trial of Allovectin-7® in patients with metastatic melanoma has completed the trial's fourth scheduled safety analysis and recommended that the trial continue per the protocol.

16 Jun 2010

Abraxis BioScience presents phase 3 trial data on metastatic malignant melanoma

Abraxis BioScience, Inc. presented trial design information from its ongoing phase 3 registration trial of nanoparticle albumin bound (nab®) driven chemotherapy, nab-paclitaxel (ABRAXANE® for Injectable Suspension; paclitaxel albumin protein-bound particles for injectable suspension), in melanoma, an aggressive form of skin cancer that affects more than 68,000 people in the U.S. each year.

11 Jun 2010

Clinical data from two separate Phase 2a combination drug studies of Azixa presented at ASCO 2010

Myriad Pharmaceuticals, Inc. today announced the presentation of clinical data from two separate Phase 2a combination drug studies of AzixaTM (MPC-6827, verubulin) at the American Society of Clinical Oncology 2010 Annual Meeting in Chicago, IL. Results from studies in both recurrent glioblastoma multiforme and stage 4 metastatic melanoma demonstrated that Azixa, in combination with standard treatments, resulted in durable responses with no added toxicity compared with chemotherapy alone.

8 Jun 2010

Genta reports combined data from Genasense Phase 3 trials for advanced melanoma

Genta Incorporated announced today the presentation of combined data on early endpoints from the Company's randomized Phase 3 trials of Genasense® (oblimersen sodium) Injection plus chemotherapy in patients with advanced melanoma. The presentation included a "pooled analysis" that assessed combined efficacy results for the endpoints of overall response and progression-free survival from both studies. The data were presented today at the 2010 annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago, IL.

7 Jun 2010