Lilly Drug Receives Key Approval

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An Eli Lilly and Co. (NYSE: LLY) cancer treatment has cleared another regulatory hurdle. Cyramza has received its third approval from the U.S. Food and Drug Administration.

December 16, 2014

News Release

INDIANAPOLIS, Ind. - 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.ii,iii,iv Approximately half of patients with metastatic NSCLC who begin first-line therapy will move on to second-line treatment.v Despite currently available therapies, there continues to be a need for new second-line treatment options for patients with NSCLC.i

Lilly is committed to offering patient assistance programs for eligible patients receiving CYRAMZA treatment. Patients, physicians, pharmacists or other healthcare professionals with additional questions about CYRAMZA should contact The Lilly Answers Center at 1-800-LillyRx (1-800-545-5979) or visit www.lilly.com. Healthcare professionals may also find additional product information on CYRAMZA at www.CYRAMZA.com.

About CYRAMZA® (ramucirumab)

CYRAMZA® (ramucirumab) is approved in combination with docetaxel (a type of chemotherapy) as a treatment for people with metastatic non-small cell lung cancer (NSCLC) whose cancer has progressed on or after platinum-based chemotherapy; it is also approved as a single agent or in combination with paclitaxel (a type of chemotherapy) as a treatment for people with advanced or metastatic gastric (stomach) or gastroesophageal junction (GEJ) adenocarcinoma whose cancer has progressed on or after prior fluoropyrimidine- or platinum-containing chemotherapy.

CYRAMZA is an antiangiogenic therapy. 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. CYRAMZA inhibited angiogenesis in an in vivo animal model.

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 and newsroom.lilly.com/social-channels.

Source: Eli Lilly and Company