Regorafenib News and Research

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New drug combination therapy effectively kills cancer cells

Results from a recent preclinical study have shown that a new drug combination therapy being developed at Virginia Commonwealth University Massey Cancer Center effectively killed colon, liver, lung, kidney, breast and brain cancer cells while having little effect on noncancerous cells. The results lay the foundation for researchers to plan a future phase 1 clinical trial to test the safety of the therapy in a small group of patients.

6 Nov 2013

European Commission approves Stivarga tablets for treatment of patients with mCRC

Bayer HealthCare and Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) announced today that the European Commission has approved Stivarga® (regorafenib) tablets for the treatment of adult patients with metastatic colorectal cancer (mCRC).

30 Aug 2013

ARIAD Pharmaceuticals initiates ponatinib Phase 2 trial in adult patients with metastatic GIST

ARIAD Pharmaceuticals, Inc. today announced the initiation of the Phase 2 trial of Iclusig (ponatinib) in adult patients with metastatic and/or unresectable gastrointestinal stromal tumors.

11 Jun 2013

Bayer HealthCare to present new data on oncology portfolio at ASCO meeting

Bayer HealthCare announced today that new data on the oncology portfolio, including Nexavar (sorafenib) tablets, Stivarga (regorafenib) tablets and the recently U.S. Food and Drug Administration approved product Xofigo (radium Ra 223 dichloride) injection will be presented at the 49th Annual Meeting of the American Society of Clinical Oncology, May 31 – June 4, in Chicago, IL (USA).

16 May 2013

Bayer HealthCare: Patient enrollment underway in Phase III trial of Stivarga tablets for treatment of HCC

Bayer HealthCare announced today that patient enrollment is underway for RESORCE (Regorafenib after Sorafenib in Patients with Hepatocellular Carcinoma), an international Phase III trial to evaluate the efficacy and safety of Stivarga (regorafenib) tablets for the treatment of patients with hepatocellular carcinoma who have progressed on Nexavar (sorafenib) tablets, an anticancer medicine for the treatment of patients with unresectable HCC.

15 May 2013

BEAMing technology detects more mutations linked with secondary drug resistance in GIST patients

A study presented at the AACR Annual Meeting 2013 indicates that a DNA blood test using Inostics' BEAMing Digital PCR can detect more mutations associated with secondary drug resistance in GIST patients than testing conventional biopsies.

9 Apr 2013

Blood test reveals more gene mutations in cancer than traditional tumor biopsy

A new blood test revealed more of the gene mutations that sustain certain digestive-tract tumors than did a DNA analysis of a traditional tumor biopsy, Dana-Farber Cancer Institute investigators will report at a special symposium of the American Association for Cancer Research annual meeting in Washington, April 6-10.

8 Apr 2013

UC Davis scientists find mechanism in metabolized omega-3 fatty acid that helps combat cancer

A team of UC Davis scientists has found that a product resulting from a metabolized omega-3 fatty acid helps combat cancer by cutting off the supply of oxygen and nutrients that fuel tumor growth and spread of the disease.

3 Apr 2013

Bayer receives FDA approval for Stivarga to treat advanced gastrointestinal stromal tumors

The U.S. Food and Drug Administration today expanded the approved use of Stivarga (regorafenib) to treat patients with advanced gastrointestinal stromal tumors (GIST) that cannot be surgically removed and no longer respond to other FDA-approved treatments for this disease.

26 Feb 2013

Regorafenib phase III results strongly support use in GIST

Regorafenib is effective for patients with gastrointestinal stromal tumors who have failed to respond to treatment with imatinib and sunitinib, trial results show.

29 Nov 2012

Bowel cancer and GIST patients could benefit from novel oral drug

Two phase 3 trials, published in The Lancet, have shown that a novel oral drug called regorafenib could offer survival benefits to people with bowel (colorectal) cancer or gastrointestinal stromal tumour (GIST) following failure of existing treatments.

22 Nov 2012

Regorafenib able to control resistant gastrointestinal stromal tumor

A new targeted drug demonstrated its ability to control metastatic gastrointestinal stromal tumor, an uncommon and life-threatening form of sarcoma, after the disease had become resistant to all existing therapies, report investigators at Dana-Farber Cancer Institute who led the worldwide clinical trial.

21 Nov 2012

Bayer HealthCare receives FDA approval for Stivarga to treat colorectal cancer

The U.S. Food and Drug Administration today approved Stivarga (regorafenib) to treat patients with colorectal cancer that has progressed after treatment and spread to other parts of the body (metastatic).

28 Sep 2012

Bayer submits regorafenib NDA with FDA for treatment of metastatic and/or unresectable GIST

Bayer HealthCare and Onyx Pharmaceuticals today announced that Bayer HealthCare has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the oral multi-kinase inhibitor regorafenib for the treatment of metastatic and/or unresectable gastrointestinal stromal tumors (GIST) in patients whose disease has progressed despite prior treatment.

31 Aug 2012

Bayer receives priority review designation from FDA for regorafenib NDA

Bayer HealthCare and Onyx Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has granted priority review designation to Bayer HealthCare's New Drug Application (NDA) filed end of April 2012 for the oral multi-kinase inhibitor regorafenib, for the treatment of patients with metastatic colorectal cancer (mCRC) whose disease has progressed after approved standard therapies.

29 Jun 2012

Onyx announces data from regorafenib Phase 3 trial on GIST

Onyx Pharmaceuticals today announced data from the Phase 3 GRID (GIST – Regorafenib In Progressive Disease) trial evaluating the investigational drug regorafenib, a Bayer compound, in patients with metastatic and/or unresectable gastrointestinal stromal tumors (GIST) whose disease had progressed despite prior treatment with imatinib and sunitinib.

4 Jun 2012

Bayer submits regorafenib NDA with FDA for treatment of mCRC

Bayer HealthCare announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the oral multi-kinase inhibitor regorafenib for the treatment of patients with metastatic colorectal cancer.

24 May 2012

Onyx announces results from regorafenib Phase 3 trial on GIST

Onyx Pharmaceuticals, Inc. today announced results from the Phase 3 trial GRID (GIST – Regorafenib in Progressive Disease) evaluating the investigational compound regorafenib (BAY 73-4506), a Bayer-owned compound, for the treatment of patients with metastatic and/or unresectable gastrointestinal stromal tumors (GIST) whose disease has progressed despite prior treatment with at least imatinib and sunitinib.

3 Apr 2012

Mayo Clinic experts available to discuss latest colorectal cancer research and treatment

March is National Colorectal Cancer Awareness Month. Colon cancer is one of the most common and deadly cancers, and also one of the most preventable. Mayo Clinic experts are available to discuss the latest in colorectal cancer research, detection and treatment.

6 Mar 2012

Onyx reports total operating revenue of $237.0M for fourth quarter 2011

Onyx Pharmaceuticals, Inc. today reported its financial results for the full year and fourth quarter 2011. Onyx reported non-GAAP net income of $42.0 million, or $0.66 per diluted share, for the full year 2011 compared to non-GAAP net income of $39.2 million, or $0.63 per diluted share, for the same period in 2010.

23 Feb 2012