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Share Name | Share Symbol | Market | Type |
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Eli Lilly and Co | NYSE:LLY | NYSE | Common Stock |
Price Change | % Change | Share Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
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-15.90 | -2.02% | 771.12 | 786.48 | 770.14 | 784.71 | 2,312,276 | 23:41:27 |
INDIANAPOLIS, Dec. 16, 2014 /PRNewswire/ -- 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 Angiogenesis
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, 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 REVEL
REVEL was a global, randomized, double-blinded Phase III study of CYRAMZA 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. In total, 1,253 patients – including people with nonsquamous (73%) and squamous (26%) forms of NSCLC – were randomized in 26 countries over six continents.i REVEL is 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.
In the trial, CYRAMZA plus docetaxel achieved a statistically significant improvement in overall survival (the primary endpoint), progression-free survival and objective response rate (secondary endpoints). CYRAMZA plus docetaxel significantly extended median overall survival compared to placebo plus docetaxel (10.5 months [95% confidence interval (CI): 9.5, 11.2] vs. 9.1 months [95% CI: 8.4, 10.0], respectively; hazard ratio 0.86 [95% CI: 0.75, 0.98]; P=0.024). Furthermore, CYRAMZA plus docetaxel significantly delayed disease progression (progression-free survival of 4.5 months for CYRAMZA plus docetaxel [95% CI: 4.2, 5.4] vs. 3.0 months for placebo plus docetaxel [95% CI: 2.8, 3.9]; hazard ratio 0.76 [95% CI: 0.68, 0.86]; P<0.001). The percentage of deaths at the time of analysis was 68% (428 patients) and 73% (456 patients) in the CYRAMZA-plus-docetaxel and placebo-plus-docetaxel arms, respectively. The progression-free survival number of events was 558 (89%) and 583 (93%) for CYRAMZA-plus-docetaxel and placebo-plus-docetaxel treatment arms, respectively. Significantly more patients responded to CYRAMZA combined with docetaxel than with placebo plus docetaxel (23% [95% CI: 20, 26] for CYRAMZA plus docetaxel vs. 14% [95% CI: 11, 17] for placebo plus docetaxel; P<0.001).
The labeling for CYRAMZA contains a Boxed Warning for hemorrhage and additional Warnings and Precautions for arterial thromboembolic events, hypertension, infusion-related reactions, gastrointestinal perforations, impaired wound healing, clinical deterioration in patients with Child-Pugh B or C cirrhosis, and reversible posterior leukoencephalopathy syndrome. In the REVEL trial, the most common adverse reactions (all grades) observed in patients treated with CYRAMZA plus docetaxel at a rate of ≥30% and ≥2% higher than placebo were neutropenia (low white blood cell count) (55% vs. 46%), fatigue/asthenia (weakness) (55% vs. 50%) and stomatitis/mucosal inflammation (37% vs. 19%). The most common serious adverse events with CYRAMZA were febrile neutropenia (fever and potentially other infection signs along with low white blood cell count) (14%), pneumonia (6%), and neutropenia (5%); 42% of patients treated with CYRAMZA plus docetaxel received granulocyte colony-stimulating factors (treatment for low white blood cells) vs. 37% of patients who received placebo plus docetaxel. See the Important Safety Information at the end of this press release and the Prescribing Information.
About Lung Cancer
Lung cancer is the leading cause of cancer death in the U.S. and most other countries, killing nearly 1.6 million people worldwide each year.ii In the U.S., lung cancer is responsible for approximately 27 percent of all cancer deaths, more than those from breast, colon and prostate cancers combined.iv Stage IV NSCLC is a very difficult-to-treat cancer and the prognosis is poor for metastatic NSCLC.vi NSCLC is much more common than other types of lung cancer, and accounts for about 85 percent of all lung cancer cases. For those people affected by NSCLC, about 70 percent have nonsquamous cell carcinoma, while about 30 percent have squamous cell carcinoma.iii 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 PatientOne
The Lilly PatientOne program addresses financial and coverage issues for qualified uninsured, underinsured and insured patients who are prescribed a Lilly Oncology product. Lilly PatientOne provides reimbursement assistance for eligible patients who are prescribed a Lilly Oncology product, such as information about coding and billing, prior authorization, benefits investigation, and denied claim appeals, as well as operating a patient assistance program. To learn more, visit www.LillyPatientOne.com or call 1-866-4PatOne (1-866-472-8663).
Indication
CYRAMZA (ramucirumab) is used with a chemotherapy called docetaxel to treat metastatic non-small cell lung cancer (NSCLC) in patients whose cancer has progressed on or after being treated with other initial types of 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.
CYRAMZA 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.
IMPORTANT SAFETY INFORMATION FOR CYRAMZA
WARNING: HEMORRHAGE |
Warnings and Precautions
Hemorrhage
Arterial Thromboembolic Events
Hypertension
Infusion-Related Reactions
Gastrointestinal Perforations
Impaired Wound Healing
Clinical Deterioration in Child-Pugh B or C Cirrhosis
Reversible Posterior Leukoencephalopathy Syndrome (RPLS)
Most Common Adverse Reactions—Single Agent
Most Common Adverse Reactions—Combination With Paclitaxel
Most Common Adverse Reactions—Combination With Docetaxel
Drug Interactions
Use in Specific Populations
For more information about CYRAMZA, including Boxed Warning for hemorrhage, please see full Prescribing Information at http://pi.lilly.com/us/cyramza-pi.pdf.
RB-P HCP ISI 16DEC2014
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.
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.
P-LLY
RB93109 12/2014 © Lilly USA, LLC 2014. ALL RIGHTS RESERVED.
CYRAMZA® is a registered trademark of Eli Lilly and Company.
This press release contains forward-looking statements about the potential of CYRAMZA (ramucirumab) as a treatment of advanced non-small cell lung 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 CYRAMZA 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.
i Garon EB, et al. Ramucirumab plus docetaxel versus placebo plus docetaxel for second-line treatment of stage IV non-small-cell lung cancer after disease progression on platinum-based therapy (REVEL): a multicentre, double-blind, randomised phase 3 trial. Lancet. 2014;384:665-73.
ii International Agency for Research on Cancer. GLOBOCAN 2012. Lung Cancer Estimated Incidence, Mortality and Prevalence Worldwide in 2012. http://globocan.iarc.fr. Accessed December 2, 2014.
iii American Cancer Society. What is non-small cell lung cancer? http://www.cancer.org/cancer/lungcancer-non-smallcell/detailedguide/non-small-cell-lung-cancer-what-is-non-small-cell-lung-cancer. Updated November 10, 2014. Accessed December 2, 2014.
iv American Cancer Society. What are the key statistics about lung cancer? http://www.cancer.org/cancer/lungcancer-non-smallcell/detailedguide/non-small-cell-lung-cancer-key-statistics. Updated November 10, 2014. Accessed December 2, 2014.
v Stinchcombe TE, Socinski MA. Considerations for Second-Line Therapy of Non-Small Cell Lung Cancer. Oncologist. 2008;13:28-36.
vi American Cancer Society. Learn about cancer: Non-small cell lung cancer survival rates by stage http://www.cancer.org/cancer/lungcancer-non-smallcell/detailedguide/non-small-cell-lung-cancer-survival-rates. Updated November 10, 2014. Accessed December 2, 2014.
Refer To: |
Tracy Henrikson (Lilly Oncology); (609) 240-3902 (mobile); tracy.henrikson@lilly.com |
Mary Coyle (TogoRun); (212) 453-2089 (office); (917) 975-6615 (mobile); m.coyle@togorun.com |
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To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/lillys-cyramza-ramucirumab-receives-third-fda-approval-300010679.html
SOURCE Eli Lilly and Company
Copyright 2014 PR Newswire
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