Navigation Links
FDA Grants Lilly's Ramucirumab Priority Review as a Potential Single-Agent Treatment for Advanced Gastric Cancer
Date:10/23/2013

INDIANAPOLIS, Oct. 23, 2013 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has assigned Priority Review to the regulatory submission for ramucirumab (IMC-1121B) as a single-agent treatment for advanced gastric cancer following disease progression after initial chemotherapy.

"We are very pleased that the FDA has granted Priority Review to ramucirumab in advanced gastric cancer, as patients with this difficult-to-treat disease typically have a poor prognosis and limited treatment options," said Richard Gaynor, M.D., vice president, product development and medical affairs for Lilly Oncology. "If approved, ramucirumab will be the first FDA-approved therapy for patients in this setting. Overall, stomach cancer is the second leading cause of cancer death globally and remains an area of high unmet need."

Priority Review status for a biologics license application, or BLA, means that the FDA's goal is to take action within eight months of a completed filing. Therefore, Lilly anticipates agency action on this application in the second quarter of 2014. The priority designation aims to expedite the review of applications for drugs that, if approved, would represent a significant advance in treatment.

This BLA for ramucirumab was based on data from REGARD, a global, randomized, double-blind Phase III study of ramucirumab plus best supportive care compared to placebo plus best supportive care as a treatment in patients with advanced gastric cancer (including adenocarcinomas of the gastro-esophageal junction) following progression after initial chemotherapy. A registration dossier is also under regulatory review by the European Medicines Agency (EMA) for a Marketing Authorization Application.
Lilly also studied ramucirumab in combination with paclitaxel for the treatment of advanced gastric cancer in its Phase III RAINBOW trial. The combination-therapy ramucirumab data from that trial will be the basis for separate regulatory applications. Lilly expects top-line results from three additional Phase III trials of ramucirumab – one each in colorectal, hepatocellular (liver) and lung cancer – in 2014.

About Ramucirumab 
Ramucirumab is designed to directly inhibit angiogenesis, a process by which blood vessels supply blood to tumors. Ramucirumab is a human, receptor-targeted antibody that specifically blocks the vascular endothelial growth factor (VEGF) receptor 2 and inhibits downstream signaling involved in the formation and maintenance of aberrant blood vessels that supply blood to tumors.

Ramucirumab, which Lilly gained through its 2008 acquisition of ImClone Systems, is being investigated in clinical trials as a single agent and in combination with other anticancer therapies for the treatment of multiple types of cancer. Beyond gastric cancer, results from three Phase III trials – one each in colorectal, hepatocellular (liver) and lung cancer – are expected in 2014.

About Lilly Oncology 
For more than five decades, Lilly Oncology has been dedicated to delivering innovative solutions that improve the care of people living with cancer. Lilly Oncology is committed to delivering life-extending and life-enhancing medicines to patients. To learn more about Lilly's commitment to cancer, please visit www.LillyOncology.com.

About Eli Lilly and Company 
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers – through medicines and information – for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com.

P-LLYThis press release contains forward-looking statements about the potential of ramucirumab as a treatment of various cancers and reflects Lilly's current beliefs. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. There is no guarantee that future studies will be positive or that ramucirumab will receive regulatory approvals or prove to be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's filings with the United States Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.Contact: Tracy Henrikson (Lilly Oncology)

Neil Hochman (TogoRun)908-243-9945 (office)

212-453-2067 (office)609-240-3902 (mobile)

516-784-9089 (mobile) Email: tracy.henrikson@imclone.com

Email: n.hochman@togorun.com (Logo: http://photos.prnewswire.com/prnh/20031219/LLYLOGO

 


'/>"/>
SOURCE Eli Lilly and Company
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Grants Orphan Drug Designation to Omeros OMS824 for Huntingtons Disease
2. European Union Grants a Good Manufacturing Practice Certificate to Nelson Laboratories
3. The Kenneth Rainin Foundation Continues its Commitment to Ending Inflammatory Bowel Disease, Awarding $1.5 Million in Research Grants
4. FDA Grants Orphan Drug Status To Eisais Investigational Compound (E7777) For Cutaneous T-Cell Lymphoma
5. FDA Grants Priority Review To New Drug Application For MNK-795 Submitted By Depomed Licensee Mallinckrodt
6. Avanir Pharmaceuticals Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)
7. Agnitio Grants 10,000 New Licenses Globally this Financial Year
8. FDA Grants Soligenix "Fast Track" Designation for SGX942 for the Treatment of Oral Mucositis in Patients with Head and Neck Cancer
9. U.S. FDA Grants Priority Review to Simeprevir (TMC435) for Combination Treatment of Genotype 1 Chronic Hepatitis C
10. Cardinal Health Foundation Invites Local Non-profit Organizations To Apply For Grants To Prevent Prescription Drug Abuse
11. FDA Grants Charleston Laboratories, Inc. Request for Pre-IND Meeting on New Migraine Treatment
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/24/2017)... GERMANTOWN, Md. , and GAITHERSBURG, Md. ... XON ), a leader in the engineering and ... health of the planet, today announced that it has entered ... (NASDAQ: GNVC ), a clinical-stage company and pioneer ... Intrexon intends to integrate and expand upon GenVec,s expertise ...
(Date:1/24/2017)... , January 24, 2017 www.Financialbuzz.com ... growing industries in the United States ... in 2016. In addition, Proposition 64, the California Cannabis Legalization ... 42.87% against on November 8, 2016. This outcome means that ... use and to grow a certain amount of cannabis for ...
(Date:1/24/2017)...   QR Pharma , Inc., a privately ... for the treatment of Alzheimer,s, Parkinson,s and other ... world-class key opinion leaders to its Scientific Advisory ... previous roster of impressive advisors in order to ... development of the breakthrough mechanism of action of ...
Breaking Medicine Technology:
(Date:1/24/2017)... ... January 24, 2017 , ... OMI Industries, ... officially formed a distribution partnership with Byers Scientific & Manufacturing , a ... , Through the agreement, OMI Industries formulated a special version of Ecosorb® for ...
(Date:1/24/2017)... ... January 24, 2017 , ... Center for Hispanic Leadership (CHL) ... named Hector M. Chavez, Manager, Employee & Labor Relations at City of Hope ... Hispanic Leader of the Month. City of Hope is committed to stay out in ...
(Date:1/24/2017)... ... January 24, 2017 , ... The University of Iowa, ... great care to design a program that provides teachers with the specific skills and ... online teaching certificate is ideal for post-baccalaureate students and HigherEducation.com is working to ensure ...
(Date:1/24/2017)... ... January 24, 2017 , ... The NewKILO JRP, a three-year project of the ... the European Union (EU), was completed in May 2015. The future definition will require ... used in air, which presents some challenges to establishing traceability to the mass scale. ...
(Date:1/24/2017)... ... January 24, 2017 , ... Today, Taza Agua, Costa ... bottles, designed specifically to optimize the drinking experience for K-Cup coffee, tea and ... introducing the world’s first untouched bottled water purposed exclusively for creating a superior ...
Breaking Medicine News(10 mins):