COMUNICADO: CHMP Recommends Approval of Lilly's Ramucirumab (CYRAMZA(TM)) for Advanced Gastric Cancer After Prior Chemotherapy (1)

COMUNICADO: CHMP Recommends Approval of Lilly's Ramucirumab (CYRAMZA(TM)) for Advanced Gastric Cancer After Prior Chemotherapy (1)

Positive Opinion Is First Regulatory Action for Ramucirumab in the EU 

INDIANAPOLIS, Sept. 26, 2014 /PRNewswire/ -- Eli Lilly and Company announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the use of ramucirumab (CYRAMZA(TM)), in adults, in combination with paclitaxel, for the treatment of advanced gastric (stomach) or gastroesophageal junction (GEJ) adenocarcinoma following prior chemotherapy and as a monotherapy in this setting for patients for whom treatment in combination with paclitaxel is not appropriate.

"Gastric cancer is a devastating and difficult-to-treat disease. Today's news brings us one step closer to providing an important new treatment option in the EU for people with this disease that has progressed on or after prior chemotherapy," said Richard Gaynor, M.D., senior vice president, product development and medical affairs for Lilly Oncology. "If approved, ramucirumab would be the first therapy approved in the EU specifically indicated for second-line gastric cancer."

This is the first regulatory action for ramucirumab in Europe in any indication. Following a CHMP positive opinion, the European Commission generally follows the recommendation and usually issues its final decision on marketing authorization within three months.

This CHMP opinion is based on results from two global, randomized, double-blind and placebo-controlled Phase III studies: RAINBOW and REGARD. RAINBOW evaluated ramucirumab in combination with paclitaxel (a type of chemotherapy) for advanced gastric or GEJ adenocarcinoma after prior chemotherapy while REGARD evaluated ramucirumab as a single agent in the same setting. Specifically, this opinion would potentially make ramucirumab available for adults in combination with paclitaxel, for the treatment of advanced gastric or GEJ adenocarcinoma following prior chemotherapy and as a monotherapy in this setting for patients for whom treatment in combination with paclitaxel is not appropriate.

Ramucirumab has been granted Orphan Drug Designation by the European Commission for treatment of gastric cancer in the EU. Orphan drug status is given to medicines that have demonstrated promise for the treatment of rare diseases.

In the United States, ramucirumab received U.S. Food and Drug Administration approval in April as a single agent for the treatment of advanced or metastatic gastric or GEJ adenocarcinoma following prior chemotherapy. Lilly expects FDA action on its submission for ramucirumab in combination with paclitaxel, in this setting, in the first half of 2015.

Notes to Editor

About the RAINBOW Trial RAINBOW was a global, randomized, double-blinded, placebo-controlled Phase III study of ramucirumab plus paclitaxel compared to placebo plus paclitaxel as a treatment in patients with advanced (locally advanced, unresectable or metastatic) gastric cancer including gastroesophageal junction (GEJ) adenocarcinoma refractory to or progressive after initial fluoropyrimidine- and platinum-containing chemotherapy. In total, 665 patients were randomized in 27 countries. The major efficacy outcome measure (i.e., primary endpoint) of the RAINBOW trial was overall survival and the supportive efficacy outcome measure (i.e., secondary endpoint) was progression-free survival.

About the REGARD Trial REGARD was a global, randomized, double-blinded, placebo-controlled Phase III study of ramucirumab plus best supportive care (BSC) compared to placebo plus BSC as a treatment in patients with locally advanced or metastatic gastric cancer including GEJ adenocarcinoma following progression after initial fluoropyrimidine- or platinum-containing chemotherapy. In total, 355 patients were randomized in 29 countries. The major efficacy outcome measure of the REGARD trial was overall survival and the supportive efficacy outcome measure was progression-free survival.

About Gastric Cancer Gastric (stomach) cancer is the fifth most common cancer in the world and the third-leading cause of cancer-related death. There were nearly one million new cases worldwide in 2012 (631,000 men, 320,000 women), with approximately 723,000 deaths (469,000 men, 254,000 women). Stomach cancer is more prevalent in countries outside the U.S. and EU.(i) In Europe, approximately 139,000 new cases of stomach cancer were diagnosed in 2012.(ii)

Gastric cancer is a disease in which cancer cells form in the stomach. It develops slowly, usually over many years, and often goes undetected.(iii) As stomach cancer advances, it can travel through the bloodstream and spread to organs such as the liver, lungs and bones.(iv)

The most common type of stomach cancer is called adenocarcinoma, which starts from one of the common cell types found in the lining of the stomach.(v)

About Ramucirumab Ramucirumab (CYRAMZA(TM)) as a single agent is approved in the United States for patients with advanced gastric cancer or gastroesophageal junction (GEJ) adenocarcinoma who have progressed after prior fluoropyrimidine- or platinum-containing chemotherapy. Ramucirumab inhibited angiogenesis in an in vivo animal model. Ramucirumab is a VEGF Receptor 2 antagonist that specifically binds and blocks activation of VEGF Receptor 2 and blocks binding of VEGF receptor ligands VEGF-A, VEGF-C, and VEGF-D.

There are several studies underway or planned to investigate ramucirumab as a single agent and in combination with other anti-cancer therapies for the treatment of multiple tumor types.

About Lilly Oncology For more than fifty years, Lilly has been dedicated to delivering life-changing medicines and support to people living with cancer and those who care for them. Lilly is determined to build on this heritage and continue making life better for all those affected by cancer around the world. To learn more about Lilly's commitment to people with cancer, please visit www.LillyOncology.com [http://www.lillyoncology.com/].

About Eli Lilly and Company Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com [http://www.lilly.com/] and http://newsroom.lilly.com/social-channels [http://newsroom.lilly.com/social-channels].

This press release contains forward-looking statements about the potential of CYRAMZA (ramucirumab) as a treatment of advanced gastric cancer 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 can be no guarantee that future study results and patient experience will be consistent with the study findings to date. There can also be no guarantee that CYRAMZA will receive regulatory approval for any future indications or that it will prove to be commercially successful. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, please see the company's latest Forms 10-K and 10-Q filed with the U.S. Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements.

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