LEL Lilly(Eli)

 
TIDMLEL 
 
Date: October 28, 2011 
 
For Release: Immediately 
 
Refer to: Caroline Harkness Grainne Maguire, TogoRun 
 
+44(0)1256 775201(Office) +44 (0) 207.554.1813 (office) 
 
+44(0)7889 718648 (mobile) +44 754.0002.009 (mobile) 
 
E-mail: harknessca@lilly.com E-mail: g.maguire@togorun.net 
 
           ALIMTA RECEIVES EC APPROVAL AS A CONTINUATION MAINTENANCE 
 
                    THERAPY FOR A FATAL FORM OF LUNG CANCER 
 
INDIANAPOLIS, USA, 28/10/11 - Eli Lilly and Company (NYSE: LLY) announced today 
that the European Commission has granted marketing authorization for the use of 
ALIMTA® (pemetrexed for injection) as continuation maintenance therapy in 
patients with advanced nonsquamous non-small cell lung cancer (NSCLC). 
 
Maintenance therapy is a relatively new concept in lung cancer treatment in 
which patients start maintenance therapy immediately following their first-line 
treatments to try to maintain disease control. Previous to this, no 
chemotherapies were approved in the "continuation maintenance" setting, in 
which one of the same medicines used in first-line treatment is continued as 
maintenance therapy. Other approved maintenance therapies in lung cancer use 
different medicines in the first-line and maintenance phases of treatment. 
 
"Lung cancer is one of the most difficult cancers to treat and new therapy 
options are much 
 
needed," said Allen Melemed, M.D., M.B.A., senior medical director with Lilly 
Oncology. 
 
"Pemetrexed is the first tailored treatment option that can potentially extend 
lives beginning in first-line treatment and continuing through maintenance in 
advanced nonsquamous non-small cell lung cancer." 
 
The EC's approval was based on results from PARAMOUNT, a randomized 
double-blind Phase III study presented in June 2011 at the American Society of 
Clinical Oncology Annual Meeting.(1) 
 
In the EU and U.S., pemetrexed is already approved in the first-line; switch 
maintenance and second-line settings for treatment of patients with advanced 
nonsquamous NSCLC. 
 
For full licensed indications of Alimta please see the SPC that can be accessed 
via link below. 
 
http://www.medicines.org.uk/emc/medicine/15513/SPC/ 
 
Notes to Editor 
 
About Non-Small Cell Lung Cancer (NSCLC) 
 
Globally, lung cancer is the most common form of cancer and the biggest killer, 
causing 1.4 million cancer deaths annually.(2) About 85 - 90 percent of all 
lung cancers are NSCLC.(3) The liver, bones and brain are potential targets if 
the cancerous cells enter the bloodstream. 
 
NSCLC comprises a group of histologies or tumor types differentiated by 
cellular structure. Nonsquamous histology includes adenocarcinoma and large 
cell carcinoma, which account for more than half of all NSCLC diagnoses, (3 ) 
as well as histologies classified as `other.' 
 
About Lilly Oncology, a Division of Eli Lilly and Company 
 
For more than four decades, Lilly Oncology, a division of Eli Lilly and 
Company, has been 
 
dedicated to delivering innovative solutions that improve the care of people 
living with cancer. Because no two cancer patients are alike, Lilly Oncology is 
committed to developing novel treatment approaches. 
 
This press release contains forward-looking statements about the potential of 
ALIMTA for the treatment of non-small cell lung cancer and reflects Lilly's 
current beliefs. However, as with any pharmaceutical product under development, 
there are substantial risks and uncertainties in the process of development, 
commercialization, and regulatory 
 
review. There is no guarantee that the product will receive additional 
regulatory approvals. There is also no guarantee that the product will continue 
to be commercially successful. For further discussion of these and other risks 
and uncertainties, see Lilly's filings with the United States Securities and 
Exchange Commission. Lilly undertakes no duty to update forward-looking 
statements. 
 
________________________________________ 
 
(1) Paz-Ares LG, De Marinis F, et.al. PARAMOUNT: Phase III study of maintenance 
pemetrexed (pem) plus best supportive care (BSC) versus 
 
placebo plus BSC immediately following induction treatment with pem plus 
cisplatin for advanced nonsquamous non-small cell lung cancer 
 
(NSCLC). J Clin Oncol 29: 2011 (suppl; abstr CRA7510). 
 
(2) World Health Organization, Gender in Lung Cancer and Smoking Research, 
Department of Gender, Women and Health, 2008, 
 
http://www.who.int/gender/documents/en/lungcancerlow.pdf, (July 25, 2011). 
 
(3) American Cancer Society, "What Is Non-Small Cell Lung Cancer?," December 
16, 2010, American Cancer Society, 
 
http://www.cancer.org/Cancer/LungCancer-Non-SmallCell/DetailedGuide/ 
non-small-cell-lung-cancer-what-is-non-small-cell-lung-cancer, (July 
 
25, 2011). 
 
UKALM0000366 Oct 2011 
 
 
 
Eli Lilly and Company 
 
Lilly Corporate Center 
 
Indianapolis, Indiana 46285 
 
U.S.A. 
 
 
 
                                     - 1 - 
 
 
 
 
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