Navigation Links
FDA Grants Fast Track Designation to Bayer's Investigational Compound Regorafenib for the Treatment of Gastrointestinal Stromal Tumors
Date:5/9/2011

WAYNE, N.J., May 10, 2011 /PRNewswire/ -- Bayer HealthCare Pharmaceuticals Inc. announced today that its investigational compound regorafenib (BAY 73-4506) has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with metastatic and/or unresectable gastrointestinal stromal tumors (GIST) whose disease has progressed despite at least imatinib and sunitinib as prior treatments.  

Regorafenib is an investigational agent and is not approved by the FDA, the European Medicines Agency (EMA) or other Health Authorities.

"There is an unmet medical need for this specific patient population," said Kemal Malik, MD, Head of Global Development and member of the Bayer HealthCare Executive Committee.  "This milestone is an important step in the overall development of regorafenib."  

In January, Bayer began enrolling patients in a randomized, double-blind, placebo-controlled Phase III study of regorafenib plus best supportive care versus placebo plus best supportive care for subjects with metastatic and/or unresectable gastrointestinal stromal tumors (GIST) whose disease has progressed despite prior treatment with at least imatinib and sunitinib (NCT01271712). The trial is estimated to enroll 170 patients, who will be randomized in a 2:1 ratio to receive either regorafenib or placebo. Subjects receiving placebo who experience disease progression may be offered open-label regorafenib treatment (cross-over option).

The primary endpoint of this trial is progression-free survival (PFS), and secondary endpoints include overall survival (OS), time to progression (TTP), disease control rate (DCR), tumor response rate (RR), duration of response (DOR), and safety. All patients will enter the Survival Follow-Up Period upon discontinuation of study treatment, during which assessment of survival status will be performed.

For information about this study, please visit www.clinicaltrials.gov (NCT01271712).

Fast Track Designation in the United States

Fast Track is a process designed to facilitate the development, and expedite the review of drugs to treat serious diseases and fill an unmet medical need.  Fast Track addresses a broad range of serious diseases.  Fast Track designation must be requested by the drug company and can be initiated at any time during the drug development process.  Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process.  The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.

About GIST

GIST is the most common form of sarcoma involving the gastrointestinal tract. GISTs arise in the GI tract, with most primary tumors originating in the stomach or small intestine. GIST represents a potentially life-threatening malignancy if the disease has spread to other parts of the body (metastasized) or is unable to be surgically removed with curative intent. The incidence of GIST is estimated to be 11 to 20 patients per million per year. The international prevalence of GISTs is comparable to that reported in the United States. In the U.S., it is estimated that there are approximately 4,500-6,000 new cases of GISTs diagnosed each year, of which about 1,500 have already metastasized when they are initially found. GISTs are difficult to diagnose and are usually found incidentally when the doctor is looking for other problems.

About Bayer HealthCare Pharmaceuticals Inc.

Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer AG. Bayer HealthCare is one of the world's leading, innovative companies in the healthcare and medical products industry, and combines the activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions.  As a specialty pharmaceutical company, Bayer HealthCare Pharmaceuticals provides products for Diagnostic Imaging, General Medicine, Hematology, Neurology, Oncology and Women's Healthcare.  The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.

BAYER (reg'd) and the Bayer Cross (reg'd) are trademarks of Bayer.

Forward-Looking Statements

This news release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.


'/>"/>
SOURCE Bayer HealthCare Pharmaceuticals Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related biology technology :

1. FDA Grants Full Approval of PROCLEIX(R) ULTRIO(R) Blood Screening Assay
2. GlaxoSmithKline To Post Quarterly US Grants Report
3. FDA Grants Fast Track Designation for OncoGenex Pharmaceuticals Lead Product Candidate OGX-011
4. CV Therapeutics Reports Option Grants Under Nasdaq Marketplace Rule 4350
5. Repligen Receives Research Grants to Support Friedreichs Ataxia Development Program
6. Cardinal Health Invites Health Care Providers to Apply for $1 Million in Grants to Fund Patient Safety Initiatives
7. EMEA Grants Kiadis Pharma Lead Product ATIR(TM) Orphan Drug Designation
8. Isis Announces Award of Up to $8.4 Million in New Government Grants and Contracts to Its Ibis Biosciences Subsidiary for Pathogen Detection and Human Forensics
9. Nasdaq Grants VirtualScopics Request for Continued Listing
10. InNexus Biotechnology Receives Patent Grants in Europe
11. New Young Investigator Grants for Probiotics Research Announced
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... , ... June 23, 2016 , ... ... release of its second eBook, “Clinical Trials Patient Recruitment and Retention Tips.” Partnering ... retention in this eBook by providing practical tips, tools, and strategies for clinical ...
(Date:6/23/2016)... HOUSTON , June 23, 2016 ... agreement with the Cy-Fair Sports Association to serve ... of the agreement, Houston Methodist Willowbrook will provide ... education and connectivity with association coaches, volunteers, athletes ... partner with the Cy-Fair Sports Association and to ...
(Date:6/23/2016)... ... June 23, 2016 , ... Supplyframe, the Industry Network for ... Design Lab . Located in Pasadena, Calif., the Design Lab’s mission is to ... are designed, built and brought to market. , The Design Lab is Supplyframe’s ...
(Date:6/23/2016)... June 23, 2016 ... 2016;12(1):22-8 http://doi.org/10.17925/OHR.2016.12.01.22 Published recently ... peer-reviewed journal from touchONCOLOGY, Andrew D Zelenetz ... of cancer care is placing an increasing burden ... expensive biologic therapies. With the patents on many ...
Breaking Biology Technology:
(Date:5/16/2016)... 2016   EyeLock LLC , a market leader ... of an IoT Center of Excellence in ... development of embedded iris biometric applications. EyeLock,s ... and security with unmatched biometric accuracy, making it the ... DNA. EyeLock,s platform uses video technology to deliver a ...
(Date:4/28/2016)... BANGALORE, India , April 28, 2016 ... subsidiary of Infosys (NYSE: INFY ), and Samsung ... global partnership that will provide end customers with a ... and payment services.      (Logo: http://photos.prnewswire.com/prnh/20130122/589162 ... for financial services, but it also plays a fundamental part ...
(Date:4/19/2016)... April 20, 2016 The new ... a compact web-based "all-in-one" system solution for all door ... reader or the door interface with integration authorization management ... control systems. The minimal dimensions of the access control ... the building installations offer considerable freedom of design with ...
Breaking Biology News(10 mins):