INDIANAPOLIS, Dec. 18, 2015 /PRNewswire/ -- Eli Lilly and Company announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued positive opinions for the use of ramucirumab (CYRAMZA()) in the following two indications:
--- In combination with docetaxel for the treatment of adult patients with
locally advanced or metastatic non-small cell lung cancer (NSCLC) with
disease progression after platinum-based chemotherapy; and
-- In combination with FOLFIRI for the treatment of adult patients with
metastatic colorectal cancer (mCRC) with disease progression on or after
prior therapy with bevacizumab, oxaliplatin and a fluoropyrimidine.
"Lung and colorectal cancer are the two leading causes of cancer mortality in the EU, together accounting for one-third of all cancer deaths - killing more than 400,000 people in the EU every year," said Richard Gaynor, M.D., senior vice president of product development and medical affairs for Lilly Oncology. "Despite currently available therapies, there continues to be a need for new second-line treatment options for patients with NSCLC and mCRC. This ramucirumab milestone is another example of Lilly's commitment to delivering treatment options for people living with lung and gastrointestinal cancers."
If approved, ramucirumab will be the first EU-approved medicine for use in combination with docetaxel in this NSCLC setting, regardless of histology.
These CHMP opinions for ramucirumab are based on results from two global, randomised, double-blinded, placebo-controlled Phase III studies: REVEL and RAISE. The REVEL trial evaluated ramucirumab plus docetaxel compared to placebo plus docetaxel in people with metastatic NSCLC whose cancer had progressed on or after prior platinum-based chemotherapy for locally advanced or metastatic disease. The REVEL study included people with nonsquamous and squamous forms of NSCLC. The RAISE trial compared ramucirumab plus FOLFIRI (irinotecan, folinic acid, and 5-fluorouracil) to placebo plus FOLFIRI in people with mCRC who had disease progression on or after prior therapy with bevacizumab, oxaliplatin and a fluoropyrimidine.
In a separate press release issued today, Lilly also announced that it received a positive CHMP opinion for necitumumab (Portrazza(TM)), in combination with gemcitabine and cisplatin chemotherapy, for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) expressing squamous NSCLC who have not received prior chemotherapy for this condition.
Following a positive CHMP opinion, the European Commission generally follows the recommendation and usually approves the new indication within two to three months.
Notes to Editor
About the REVEL Trial REVEL was a global, randomised, double-blinded Phase III study of ramucirumab plus docetaxel compared to placebo plus docetaxel in people with metastatic non-small cell lung cancer (NSCLC) whose cancer had progressed on or after prior platinum-based chemotherapy for locally advanced or metastatic disease. In total, 1,253 patients - including people with nonsquamous (73%) and squamous (26%) forms of NSCLC - were randomised in 26 countries over six continents. Efficacy endpoints in the trial included the major efficacy outcome measure of overall survival and the supportive efficacy outcome measures of progression-free survival and objective response rate.(1 )REVEL was the first positive Phase III study of a biologic in combination with chemotherapy to demonstrate improved overall survival compared to chemotherapy alone in second-line metastatic NSCLC, regardless of histology.
About the RAISE Trial RAISE was a global, randomised, double-blinded, placebo-controlled Phase III study of ramucirumab in combination with FOLFIRI (irinotecan, folinic acid, and 5-fluorouracil) in patients with mCRC with disease progression on or after prior therapy with bevacizumab, oxaliplatin and a fluoropyrimidine. In total, 1,072 patients were randomised across 24 countries in North America, South America, Europe, Australia and Asia. Efficacy endpoints in the trial included the major efficacy outcome measure of overall survival and the supportive efficacy outcome measures of progression-free survival and objective response rate.(2)
About Lung Cancer Lung cancer is the leading cause of cancer death worldwide, killing nearly 1.6 million people globally each year.((3)) Lung cancer is the leading cause of cancer death in the EU, where it is responsible for approximately 21 percent of all cancer deaths, taking approximately 268,000 lives each year.(3) Stage IV NSCLC is a very difficult-to-treat cancer and the prognosis is poor for metastatic NSCLC.
NSCLC is much more common than other types of lung cancer, and accounts for about 85 percent of all lung cancer cases.(4) For those people affected by NSCLC, about 70 percent have nonsquamous cell carcinoma, while about 30 percent have squamous cell carcinoma.(4) Approximately half of patients with metastatic NSCLC who begin first-line therapy will move on to second-line treatment.(5) Despite currently available therapies and recent advances, there continues to be a need for new second-line treatment options for patients with NSCLC.(1)
About Colorectal Cancer Colorectal cancer (CRC) is a cancer that develops in the colon or the rectum, which are both parts of the gastrointestinal system. Metastatic CRC (mCRC) occurs when the disease has spread to at least one distant organ, such as the liver, lungs, or lining of the abdomen.
Despite advances in treating CRC in recent years, the mortality rate remains significant. CRC is the fourth leading cause of cancer deaths worldwide, killing nearly 700,000 people in 2012.(6,7) CRC is the second leading cause of cancer deaths in the EU, where it is responsible for about 12 percent of all cancer deaths, taking approximately 152,000 lives each year.(8)
About Ramucirumab The European Commission approved ramucirumab (CYRAMZA()) on December 19, 2014 in combination with paclitaxel for the treatment of adult patients with advanced gastric (stomach) or gastroesophageal junction (GEJ) adenocarcinoma with disease progression following prior platinum and fluoropyrimidine chemotherapy and as a monotherapy in this setting for patients for whom treatment in combination with paclitaxel is not appropriate. Additionally, ramucirumab is approved in the U.S. to treat advanced or metastatic forms of gastric, non-small cell lung and colorectal cancer, and in Japan and several other countries to treat advanced gastric cancer.
Ramucirumab is an antiangiogenic therapy. Ramucirumab inhibited angiogenesis in an in vivo animal model. It is a vascular endothelial growth factor (VEGF) Receptor 2 antagonist that specifically binds and blocks activation of VEGF Receptor 2 by blocking the binding of VEGF receptor ligands VEGF-A, VEGF-C, and VEGF-D. VEGF Receptor 2 is the key mediator of VEGF induced angiogenesis. VEGF-mediated angiogenesis is involved in the pathogenesis of several diseases, including gastric, lung and colorectal cancers.(9,10,11,12)
There are several additional 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. This broad global development program has enrolled more than 8,000 patients across more than 50 trials of ramucirumab worldwide.
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.
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