-- First approved therapy in the EU specifically indicated for second-line gastric cancer
INDIANAPOLIS, Dec. 22, 2014 /PRNewswire/ -- Eli Lilly and Company today announced that the European Commission has granted marketing authorisation for ramucirumab (CYRAMZA()) 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. This is the first regulatory approval for ramucirumab in the EU in any indication.
"Today marks an important milestone in the treatment of advanced gastric cancer across the EU, as patients and healthcare professionals now have an approved medicine specifically indicated for second-line treatment of this difficult-to-treat disease," said Richard Gaynor, M.D., senior vice president, product development and medical affairs for Lilly Oncology. "We are proud to deliver on our commitment to supporting people living with cancer and those who care for them."
This EU marketing authorisation is based on results from two global, randomised, double-blinded 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.(i,ii)
Ramucirumab has been granted Orphan Drug Designation by the European Medicines Agency's Committee for Orphan Medicinal Products (COMP) for the treatment of gastric cancer in the EU. Orphan drug status is given to medicines for the treatment of rare diseases that provide significant benefit over existing treatments.
Notes to Editor
About the RAINBOW Trial RAINBOW was a global, randomised, 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 GEJ adenocarcinoma refractory to or progressive after initial fluoropyrimidine- and platinum-containing chemotherapy. In total, 665 patients were randomised in 27 countries.(i) 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, randomised, 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 randomised in 29 countries.(ii) 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. In the EU, stomach cancer is rare; it is estimated that the total number of new cases of stomach cancer diagnosed in 2012 in France, Germany, Italy, Spain and the UK was approximately 50,000.(iii)
Gastric cancer is a disease in which cancer cells form in the stomach. It develops slowly, usually over many years, and often goes undetected. 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 In the EU, ramucirumab (CYRAMZA()) has been granted marketing authorisation for use in adults, in combination with paclitaxel, for the treatment of advanced gastric 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. Ramucirumab is approved in the U.S. for the treatment of people with advanced or metastatic gastric or GEJ adenocarcinoma following prior chemotherapy.
Ramucirumab is an antiangiogenic therapy. It 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, by blocking and binding of VEGF receptor ligands VEGF-A, VEGF-C, and VEGF-D. VEGF-mediated angiogenesis is involved in the pathogenesis of several diseases, including advanced gastric cancer.(vi,vii)
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 tumour 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 newsroom.lilly.com/social-channels [http://newsroom.lilly.com/social-channels].
This press release contains forward-looking statements about the potential of ramucirumab (CYRAMZA) 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 ramucirumab 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.
(CONTINUA)
