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FDA Grants Lilly's Ramucirumab Priority Review as a Potential Single-Agent Treatment for Advanced Gastric Cancer



  FDA Grants Lilly's Ramucirumab Priority Review as a Potential Single-Agent
                    Treatment for Advanced Gastric Cancer

PR Newswire

INDIANAPOLIS, Oct. 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-LLY

This 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

Website: http://www.lilly.com
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