Lilly receives FDA approval for CYRAMZA (ramucirumab)

Eli Lilly and CompanyDec 16 2014

Eli Lilly and Company (NYSE: LLY) has received its third U.S. Food and Drug Administration (FDA) approval for CYRAMZA^® (ramucirumab).

Specifically, CYRAMZA is now also indicated in combination with docetaxel, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with disease progression on or after platinum-based chemotherapy. Patients with epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving CYRAMZA. This latest approval of CYRAMZA was received on December 12, 2014.

This approval of CYRAMZA (ramucirumab injection 10 mg/mL solution) marks the first FDA-approved medicine for use in combination with docetaxel in the second-line treatment of metastatic NSCLC, including nonsquamous and squamous histologies.

"Lilly is determined to meet the challenge of delivering new treatments for people with difficult-to-treat cancers, such as non-small cell lung cancer," said Sue Mahony, Ph.D., senior vice president and president, Lilly Oncology. "We are pleased with this approval and excited for the therapeutic advantage that CYRAMZA in combination with docetaxel can bring to second-line, metastatic NSCLC patients. It truly builds on Lilly's continued commitment to discovering potential treatment options for people fighting lung cancer."

The REVEL Phase III trial compared CYRAMZA plus docetaxel to placebo plus docetaxel, and included people with nonsquamous and squamous forms of NSCLC. 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.ⁱ The labeling for CYRAMZA contains a Boxed Warning regarding increased risk of hemorrhage, including severe and sometimes fatal hemorrhagic events. CYRAMZA should be permanently discontinued in patients who experience severe bleeding. See the Important Safety Information at the end of this press release and the Prescribing Information.

Lung cancer is the leading cause of cancer death in the U.S. and most other countries, and NSCLC accounts for about 85 percent of all lung cancer cases. Approximately half of patients with metastatic NSCLC who begin first-line therapy will move on to second-line treatment. Despite currently available therapies, there continues to be a need for new second-line treatment options for patients with NSCLC.