Navigation Links
Bayer Submits New Drug Application for Regorafenib for the Treatment of Gastrointestinal Stromal Tumors (GIST)
Date:8/30/2012

WAYNE, N.J. and SOUTH SAN FRANCISCO, Calif., Aug. 30, 2012 /PRNewswire/ -- Bayer HealthCare and Onyx Pharmaceuticals (NASDAQ: ONXX) 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.

Regorafenib is a Bayer compound developed by Bayer. In 2011, Bayer entered into an agreement with Onyx Pharmaceuticals, Inc. under which Onyx will receive a royalty on any future global net sales of regorafenib in oncology. Bayer and Onyx will jointly promote regorafenib in the United States.

"The submission of regorafenib for the treatment of GIST marks an important milestone for Bayer, bringing us one step closer to potentially addressing a significant medical need for patients with this rare but aggressive disease," said Pamela A. Cyrus, M.D., Vice President and Head of U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals. "With the development of regorafenib and other oncology compounds, we remain committed to discovering and advancing cancer therapies for patients who are in need of new treatment options."

The submission is based on data from the pivotal Phase III GRID (GIST – Regorafenib In Progressive Disease) trial, which showed that regorafenib plus best supportive care (BSC) significantly improved progression-free survival (PFS) compared to placebo plus BSC [HR=0.27 (95% CI 0.19-0.39), p<0.0001] in patients with metastatic and/or unresectable GIST who were previously treated with imatinib and sunitinib. The median PFS was 4.8 months in the regorafenib arm versus 0.9 months in the placebo arm and there was a positive trend in the regorafenib group in improv
'/>"/>

SOURCE Bayer HealthCare Pharmaceuticals Inc.
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. U.S. FDA Grants Priority Review to the New Drug Application for Bayers Regorafenib to Treat Patients with Metastatic Colorectal Cancer
2. Zacks Bull and Bear of the Day Highlights: Discover Financial Services, POSCO, AstraZeneca, Bayer and Takeda Pharmaceutical
3. Bayer Partnership Delivers Industry-First Dose Management Offering
4. Regeneron and Bayer Announce Co-Promotion Agreement With Santen For EYLEA® (aflibercept) Injection in Japan
5. Bayer Employees Named Rising Stars by Healthcare Businesswomens Association
6. Delcath Submits New Drug Application For Proprietary Chemosaturation System To The U.S. Food And Drug Administration
7. Takeda Resubmits New Drug Applications to the United States Food and Drug Administration for Alogliptin and the Fixed-Dose Combination Alogliptin and Pioglitazone
8. Janssen Research & Development Submits New Drug Application to U.S. FDA for Canagliflozin to Treat Patients with Type 2 Diabetes
9. Janssen Research & Development Submits XARELTO® (rivaroxaban) to U.S. FDA for the Treatment and Prevention of Recurrent Venous Thromboembolism
10. Zogenix Submits New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for Zohydro™ for Treatment of Chronic Pain
11. Varying Technology and Application Trends Pep up the Mature Research Antibodies Market, Finds Frost & Sullivan
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/21/2014)... Conn. , Aug. 21, 2014  Aptuit ... West Lafayette, Indiana , has enhanced ... and characterization of small and large molecules, including ... of the Bruker maXisPlus Q-TOF mass spectrometer. ... Goldman , CEO, Aptuit, said, "The expanded large ...
(Date:8/21/2014)... 2014  eRelevance Corporation ( www.erelevancecorp.com ), a ... it has completed integration with Nextech, a popular ... and Dermatology practices. "Integration allows our ... practices using Nextech," stated Bob Fabbio , ... from the EMR we are able to automatically ...
(Date:8/21/2014)... TORONTO , Aug. 21, 2014 /CNW/ - The Canadian ... a new comic series designed to educate children about the ... epilepsy.  The Medikidz Explain Epilepsy comic series tells ... who is navigating middle school while living with epilepsy. ... 100 Canadians, there is still so much misinformation and lack ...
Breaking Medicine Technology:Aptuit SSCI Adds Ultra High Resolution Q-TOF Mass Spectrometer for Large & Small Molecule Analyses 2eRelevance Corporation Integrates with Nextech Electronic Medical Records 2Action Heroes Harness Powers to Educate Children About Epilepsy 2Action Heroes Harness Powers to Educate Children About Epilepsy 3
... NewCardio, Inc., (OTC BB: NWCI) a cardiac diagnostic technology provider, ... 30, 2011. More details on the financial results are available ... with the Securities and Exchange Commission. Highlights ... global pharmaceutical company for two Phase I drug safety studies, ...
... Millennium HealthCare Inc. (Symbol: MHCC) announced today that ... Oversight Board (PCAOB) accounting firm as the Company,s accountant ... a combination of technology, intellectual capital and experience with ... entrepreneurial spirit and a reputation for excellence.  The Company ...
Cached Medicine Technology:NewCardio Announces Financial Results for Its 2011 Second Quarter 2NewCardio Announces Financial Results for Its 2011 Second Quarter 3NewCardio Announces Financial Results for Its 2011 Second Quarter 4NewCardio Announces Financial Results for Its 2011 Second Quarter 5NewCardio Announces Financial Results for Its 2011 Second Quarter 6NewCardio Announces Financial Results for Its 2011 Second Quarter 7NewCardio Announces Financial Results for Its 2011 Second Quarter 8Millennium HealthCare Inc. Engages KBL, LLP 2
(Date:8/22/2014)... News) -- Many Americans know little about how Ebola is ... outbreak in the United States, a new survey shows. ... there will be a major Ebola outbreak in the United ... family member will get sick with the deadly virus in ... Public Health poll. However, those opinions don,t match reality, ...
(Date:8/22/2014)... NV (PRWEB) August 22, 2014 Mi40x ... uses university-proven research to show people how they can use ... muscle in only a matter of weeks has caught the ... “Ben Pakulski is one of the most well-known bodybuilders in ... the body he has today, that in itself is a ...
(Date:8/22/2014)... August 22, 2014 Paying tuition and ... in the coming year for four nurse educators pursuing ... National League for Nursing Foundation for Nursing Education . ... share $28,000, $10,000 more than in 2013, thanks to ... Endowment and Elizabeth Isaac Marcil Endowment Funds, both donated ...
(Date:8/22/2014)... Wisconsin (PRWEB) August 22, 2014 Mueller ... for Plantar Fasciitis, an exciting new product that provides ... you to stay active while you heal. The package ... is truly a new technology – it is not ... , FasciaDerm® PFTape™ System for Plantar Fasciitis ...
(Date:8/22/2014)... Orange, NJ. August 22, 2014. A new ... that persons with multiple sclerosis (MS) may be ... rehabilitation. The study was epublished ahead of print ... Goverover, Helen Genova, Hali Griswold, Nancy D. Chiaravalloti ... in persons with multiple sclerosis doi: 10.3233/NRE-141113). Self-awareness ...
Breaking Medicine News(10 mins):Health News:Many Americans Harbor Unfounded Fears About Ebola Outbreak: Survey 2Health News:Mi40x: Review Exposes Ben Pakulski’s Guide to Packing on Lean Muscle Fast 2Health News:NLN Foundation for Nursing Education Announces 2014 Faculty Scholarship Awards 2Health News:NLN Foundation for Nursing Education Announces 2014 Faculty Scholarship Awards 3Health News:Mueller Introduces FasciaDerm® PFTape™ System for Plantar Fasciitis 2Health News:Kessler Foundation study of self-awareness in MS has implications for rehabilitation 2
... report released today reveals that California ranks in the bottom ... and the District of Columbia in the percentage of ... According to "Reading Across the Nation: A Chartbook," prepared by ... the nonprofit Reach Out and Read National Center, only 44.6 ...
... today in a special supplement to the Journal of General ... patients who speak little, if any, English and the impact ... The studies overall report that measurable disparities in quality of ... same language. , Hospitalized Patients Who ...
... An unforgettable evening of good food, ... The 12th Annual Tallahassee,Wine and Food Festival culminates tomorrow evening ... around the world, including,unique varietals from Argentina and South Africa. ... fun-filled sessions about wine:, * Basics of Wine Tasting ...
... 1 Fibromyalgia is the most common,widespread chronic ... than,six million Americans. But, findings from two new ... there is still much to be,learned about this ... public shows nearly half (45%) of respondents,have never ...
... to Postal Service Social Awareness Stamp,Series, WASHINGTON, Nov. ... year to help raise awareness about Alzheimer,s disease,as part ... announced today, on the first day of both National ... "With the Alzheimer,s Awareness commemorative stamp, we,ll ask,Americans to ...
... NexGenix Pharmaceuticals, a privately,held biotechnology company focused on ... disorder neurofibromatosis and related sporadic,tumors, today announced that ... will be presenting at the Acumen BioFin and ... pm on November 5th, 2007,at the New York ...
Cached Medicine News:Health News:Report shows less than half of kids in California are being read to daily 2Health News:Report shows less than half of kids in California are being read to daily 3Health News:JGIM: studies show importance of language services on disparities, quality of care 2Health News:JGIM: studies show importance of language services on disparities, quality of care 3Health News:JGIM: studies show importance of language services on disparities, quality of care 4Health News:JGIM: studies show importance of language services on disparities, quality of care 5Health News:Take a Culinary Trip Around the World for a Good Cause: March of Dimes 2Health News:Medialink Features: The Painful Truth About Fibromyalgia 2Health News:Alzheimer's Disease to be Highlighted on Stamp Next Year 2Health News:NexGenix Pharmaceuticals to Present at Acumen BioFin Rodman & Renshaw 9th Annual Healthcare Conference 2