The U.S. Food and Drug Administration has issued a fourth approval for a cancer treatment from Indianapolis-based Eli Lilly and Co. (NYSE: LLY). Cyramza is now approved for treatment of certain forms colorectal cancer.

April 24, 2015

News Release

Indianapolis, Ind. — Eli Lilly and Company (NYSE: LLY) has received its fourth U.S. Food and Drug Administration (FDA) approval for CYRAMZA (ramucirumab). CYRAMZA (ramucirumab injection 10 mg/mL solution) is now also indicated in combination with FOLFIRI (irinotecan, folinic acid, and 5-fluorouracil) chemotherapy for the treatment of patients with metastatic colorectal cancer (mCRC) with disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine.

“CYRAMZA now has approvals in advanced or metastatic forms of three of the world's most common and deadly cancers – gastric, non-small cell lung, and colorectal – with four FDA approvals received in just over a year,” said Sue Mahony, Ph.D., senior vice president and president, Lilly Oncology. “This progress is encouraging and supports our ongoing development program for CYRAMZA. Achieving today's milestone is another example of Lilly's commitment to people living with gastrointestinal cancers.”

Dr. Mahony added, “We are also pleased with the efficient and collaborative reviews we had with the FDA on these submissions.” While granted a standard review, this application for CYRAMZA in mCRC was reviewed and approved in approximately nine weeks following its submission to the FDA. All three supplemental applications for CYRAMZA received FDA approval within six months from the time of submission.

The approval is based on the Phase III trial known as RAISE, which compared CYRAMZA plus FOLFIRI to placebo plus FOLFIRI in people with mCRC who had disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine. Efficacy endpoints in the trial included the major efficacy outcome measure of overall survival (OS) and the supportive efficacy outcome measure of progression-free survival (PFS). The labeling for CYRAMZA contains Boxed Warnings for: hemorrhage, including severe and sometimes fatal events; gastrointestinal (GI) perforation, a potentially fatal event; and impaired wound healing. CYRAMZA should be permanently discontinued in patients who experience severe bleeding or a GI perforation. CYRAMZA should be withheld prior to surgery and discontinued if a patient develops wound healing complications. See the Important Safety Information at the end of this press release and the Prescribing Information.

For patients receiving CYRAMZA treatment, Lilly is committed to offering patient assistance programs. 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)

In the U.S., CYRAMZA (ramucirumab) is approved for use 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. It is also 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. Additionally, it is approved with FOLFIRI (a type of chemotherapy) as a therapy for people with metastatic colorectal cancer (mCRC) whose cancer has progressed on or after therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine.

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 Angiogenesis and VEGF

Angiogenesis is the process of making new blood vessels. In a person with cancer, angiogenesis creates new blood vessels that give a tumor its own blood supply, allowing it to grow and spread.

Some tumors create proteins called VEGF. These proteins attach to the VEGF receptors of blood vessel cells, causing new blood vessels to form around the tumors and enabling growth. Blocking the VEGF protein from linking to the blood vessels helps to inhibit tumor growth by slowing angiogenesis and the blood supply that feeds tumors. Of the three known VEGF receptors, VEGF Receptor 2 is linked most closely to VEGF-induced tumor angiogenesis.

About the RAISE Trial

RAISE was a global, double-blind Phase III study of CYRAMZA plus FOLFIRI compared to placebo plus FOLFIRI as a second-line treatment for mCRC in patients who had disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine. Patients were randomized in a 1:1 ratio to receive CYRAMZA plus FOLFIRI (n=536) or placebo plus FOLFIRI (n=536) every two weeks.

In the RAISE trial, patients treated with the CYRAMZA-FOLFIRI combination achieved a median OS, the study's primary endpoint, of 13.3 months as compared to those treated with placebo-FOLFIRI who achieved 11.7 months, a statistically significant improvement that reduced the risk of patient death by 15 percent (HR 0.85; 95% CI: 0.73-0.98; p=0.023). The percentage of deaths at the time of analysis was 69 percent (372 patients) and 74 percent (397 patients) in the CYRAMZA-plus-FOLFIRI and placebo-plus-FOLFIRI treatment arms, respectively. The CYRAMZA combination also demonstrated a statistically significant improvement in the secondary endpoint of PFS over the placebo-FOLFIRI regimen, with a median PFS of 5.7 months vs. 4.5 months, respectively (HR 0.79; 95% CI: 0.70-0.90; p < 0.001).="" the="" percentage="" of="" events="" at="" the="" time="" of="" analysis="" was="" 89="" percent="" (476="" patients)="" and="" 92="" percent="" (494="" patients)="" in="" the="" cyramza-plus-folfiri="" and="" placebo-plus-folfiri="" treatment="" arms,="" respectively.="" in="" the="" raise="" trial,="" randomization="" was="" stratified="" by="" geographic="" region,="" tumor="" kras="" status,="" and="" time="" to="" disease="" progression="" after="" beginning="" first-line="" treatment="" (="">< 6="" months="" vs.="" ≥6="" months).="" the="" treatment="" effect="" was="" consistent="" across="" the="" pre-specified="" stratification="">

The labeling for CYRAMZA contains Boxed Warnings for hemorrhage, GI perforation, and impaired wound healing and additional Warnings and Precautions for arterial thromboembolic events, hypertension, infusion-related reactions, clinical deterioration in patients with Child-Pugh B or C cirrhosis, reversible posterior leukoencephalopathy syndrome, proteinuria including nephrotic syndrome, thyroid dysfunction, and embryofetal toxicity. The most common adverse reactions (all grades) observed in CYRAMZA-plus-FOLFIRI-treated patients at a rate of ≥30 percent and ≥2 percent higher than placebo plus FOLFIRI were diarrhea (60% vs. 51%), neutropenia (59% vs. 46%), decreased appetite (37% vs. 27%), epistaxis (33% vs. 15%), and stomatitis (31% vs. 21%). The most common serious adverse events with CYRAMZA plus FOLFIRI were diarrhea (3.6%), intestinal obstruction (3.0%), and febrile neutropenia (2.8%). See the Important Safety Information at the end of this press release and the Prescribing Information.

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 second leading cause

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