ALIMTA(R) Recommended by Special Health Authority in United Kingdom as Maintenance Therapy for Advanced, Nonsquamous Non-Small Cell Lung Cancer

INDIANAPOLIS, April 1 /PRNewswire-FirstCall/ -- Eli Lilly and Company (NYSE: LLY) announced today that its chemotherapy ALIMTA® (pemetrexed for injection) received a positive "Final Appraisal Determination" from the United Kingdom's National Institute for Health and Clinical Excellence (NICE).  

Specifically, NICE's Final Appraisal Determination recommends ALIMTA as an option for the maintenance treatment of people with locally advanced or metastatic non-small cell lung cancer with other than predominantly squamous cell (nonsquamous) histology if disease has not progressed immediately following platinum-based chemotherapy first-line chemotherapy.(1)  This recommendation is the second step in a three-step approval process; NICE expects to issue its final guidance this summer.

ALIMTA was approved in July 2009 in the same setting by the European Commission. However, without a positive recommendation from NICE, patients struggle to get access under the UK's state funding agency, the National Health Service (NHS).  NICE is a special health authority of the NHS.

The U.S. Food and Drug Administration (FDA) similarly approved ALIMTA in July 2009 for the treatment of patients with non-small cell lung cancer to maintain the effect of initial treatment with chemotherapy and whose disease has not worsened.  ALIMTA is not indicated for patients who have a different type of NSCLC, called squamous cell.

ALIMTA has previously received positive, final recommendations from NICE as a first-line treatment in combination with cisplatin for locally advanced and metastatic non-small cell lung cancer for patients with other than predominantly squamous cell (nonsquamous) histology, as well as a treatment for metastatic pleural mesothelioma, also used in combination with cisplatin.

"This decision is a promising step toward recognizing the value of ALIMTA for patients, payer organizations and doctors," said John H. Johnson, president of Lilly Oncology.  "Most importantly, it means more advanced nonsquamous NSCLC patients may have access to treatment that can potentially prolong their lives."

Maintenance therapy represents a new approach in treating advanced nonsquamous NSCLC.  Traditionally, patients who respond to first-line chemotherapy are monitored until the disease recurs and are then treated with a second-line regimen.  In maintenance therapy, rather than halting further treatment until disease progression, patients who have disease control following first-line therapy are treated immediately with a maintenance regimen.

The NICE recommendation for ALIMTA was based on data that demonstrated it improved overall survival for advanced nonsquamous NSCLC cancer patients in the maintenance setting.   The appraisal committee concluded that the evidence submitted fulfilled the end of life criteria.

Overall survival data for ALIMTA as a maintenance therapy for NSCLC was presented on May 31, 2009 at the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO).(2)  The global, multicenter, double-blind Phase III trial compared efficacy with respect to overall survival of ALIMTA plus best supportive care versus placebo plus best supportive care in 663 patients with stage IIIB/IV NSCLC whose disease had not progressed after four cycles of platinum-based induction chemotherapy.  ALIMTA was not included among the induction regimens studied in the maintenance trial. Myelosuppresion is usually the dose-limiting toxicity with ALIMTA therapy.

Patients in the trial were treated with ALIMTA (500 mg/m2 on day one of each 21-day cycle) plus best supportive care or placebo plus best supportive care.  All patients were supplemented with vitamin B12, folic acid and dexamethasone.

For more information about ALIMTA, please see the full prescribing information (http://pi.lilly.com/us/alimta-pi.pdf) and patient prescribing information (http://pi.lilly.com/us/alimta-ppi.pdf). You may also learn more about ALIMTA at www.Alimta.com.

Important Safety Information for ALIMTA (pemetrexed for injection)

ALIMTA is approved by the FDA in combination with cisplatin (another chemotherapy drug) for the initial treatment of advanced nonsquamous non-small cell lung cancer (NSCLC), a specific type of NSCLC.  ALIMTA is not indicated for patients who have a different type of NSCLC called squamous cell.

ALIMTA is approved by the FDA for the treatment of patients with advanced nonsquamous non- small cell lung cancer (NSCLC), a specific type of NSCLC, to maintain the effect of initial treatment with chemotherapy and whose disease has not worsened.  ALIMTA is not indicated for patients who have a different type of NSCLC called squamous cell.

ALIMTA is approved by the FDA as a single agent (used alone) for the treatment of patients with advanced nonsquamous non-small cell lung cancer (NSCLC), a specific type of NSCLC, after prior chemotherapy.  ALIMTA is not indicated for patients who have a different type of NSCLC called squamous cell.

ALIMTA is a treatment for malignant pleural mesothelioma (MPM), which is a cancer that affects the inside lining of the chest cavity.  ALIMTA is given with cisplatin, another anticancer medicine (chemotherapy), when surgery is not an option.

ALIMTA may not be appropriate for some patients. If you are allergic to ALIMTA, tell your doctor because you should not receive it. If you think you are pregnant, are planning to become pregnant, or are nursing, please tell your healthcare team. ALIMTA may harm your unborn or nursing baby.  Your physician may advise you to use effective contraception (birth control) to prevent pregnancy while you are being treated with ALIMTA.

If you have liver or kidney problems, be sure to tell your doctor. Your dose of ALIMTA may have to be changed, or ALIMTA may not be right for you.  There is a risk of side effects associated with ALIMTA therapy.  ALIMTA can suppress bone marrow function.  It is very important to take folic acid and vitamin B12 prior to and during your treatment with ALIMTA to lower your chances of harmful side effects.

Your healthcare professional will prescribe a medicine called a corticosteroid, which lowers your chances of getting skin reactions with ALIMTA.  Ask your healthcare professional before taking medicines called NSAIDs (nonsteroidal anti-inflammatory drugs used to treat pain or swelling).  Tell your doctor if you are taking other medicines, including prescription and non-prescription medicines, vitamins, and herbal supplements.

The most common side effects of ALIMTA when given alone or in combination with cisplatin, another chemotherapy drug, are low blood cell counts (red blood cells, white blood cells, and platelets); tiredness; stomach upset, including nausea, vomiting, and diarrhea; mouth, throat, or lip sores; loss of appetite; rash; and constipation.

Call your healthcare professional right away if you have a fever, chills, diarrhea, or mouth sores. These symptoms could mean you have an infection.  These are not all of the side effects of ALIMTA.  If you have any side effect that bothers you or that does not go away, be sure to talk with your healthcare professional.

You will have regular blood tests before and during your treatment with ALIMTA.  Your doctor may adjust your dose of ALIMTA or delay your treatment based on the results of your blood test and on your general condition.

For more information about all of the side effects of ALIMTA, please talk with your healthcare team, see the Patient Prescribing Information and full Prescribing Information, visit http://www.ALIMTA.com, or call 1-800-545-5979.

You are encouraged to report negative side effects of prescription drugs to the FDA.  Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.

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 1.3 million cancer deaths annually.(3)  About 85 - 90 percent of all lung cancers are NSCLC.(4)  NSCLC has five-tier staging, starting at 0 and rising to the severity of stage IV.(5)  NSCLC can spread through the lymphatic system, penetrating the chest lining, ribs, and the nerves and blood vessels that lead to the arm.  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(4), as well histologies classified as "other."

About Lilly Oncology

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.    

About Lilly

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations.  Headquartered in Indianapolis, Ind., Lilly provides answers – through medicines and information – for some of the world's most urgent medical needs.  Additional information about Lilly is available at lilly.com.

P-LLY

This press release contains forward-looking statements about the potential of ALIMTA as a  maintenance therapy 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 is 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) National Institute for Health and Clinical Excellence, Final Appraisal Determination: Pemetrexed for the maintenance treatment of non-small-cell lung cancer, http://www.nice.org.uk. Accessed April 1, 2010.

(2) C. P. Belani, T. Brodowicz, et al., Maintenance pemetrexed (Pem) plus best supportive care (BSC) versus placebo (Plac) plus BSC: A randomized phase III study in advanced non-small cell lung cancer (NSCLC). Abstract #CRA8000. 2009 American Society of Clinical Oncology (ASCO) Annual Meeting. J Clin Oncol 27:18s, 2009 (suppl; abstr CRA8000).

(3) World Health Organization, Gender in Lung Cancer and Smoking Research, Department of Gender, Women and Health, 2003, http://www.who.int/gender/documents/en/lungcancerlow.pdf.

(4) American Cancer Society, "What Is Non-Small Cell Lung Cancer?," October 20, 2009, American Cancer Society, http://www.cancer.org/docroot/CRI/content/CRI_2_4_1x_What_Is_Non-Small_Cell_Lung_Cancer.asp?rnav=cri.  Accessed March 16, 2010.

(5) American Cancer Society, "How Is Non-Small Cell Lung Cancer Staged?" October 20, 2009, American Cancer Society, http://www.cancer.org/docroot/CRI/content/CRI_2_4_3x_How_Is_Non-Small_Cell_Lung_Cancer_Staged. asp?rnav=cri. Accessed March 16, 2010.

(Logo:  http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )

SOURCE Eli Lilly and Company