INDIANAPOLIS — Eli Lilly and Company (NYSE: LLY) announced today that the European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the use of ALIMTA(R) (pemetrexed for injection) as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy.
Following a positive opinion by the CHMP, any potential approval in the European Union (EU) is usually granted by the European Commission (EC) within two months. Lilly has also filed for approval of pemetrexed in the same indication with the U.S. Food and Drug Administration (FDA).
Should the EC approve the use of pemetrexed as maintenance treatment for NSCLC, it would mark the first chemotherapy approved for this indication. In the EU and U.S., pemetrexed is already approved, in combination with cisplatin, as a first-line treatment for locally-advanced or metastatic nonsquamous NSCLC for patients, and it is indicated as a single agent for the second-line treatment of patients with locally advanced or metastatic nonsquamous NSCLC after prior chemotherapy. Pemetrexed also is indicated, in combination with cisplatin, for the treatment of chemotherapy naive patients with unresectable malignant pleural mesothelioma.
Globally, lung cancer is the most common form of cancer and the biggest killer, causing 1.3 million deaths annually.(1) About 85 – 90 percent of all lung cancers are NSCLC.(2) NSCLC is defined as a group of histologies, that is, 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.”
“This recommendation from the CHMP is encouraging,” said Richard Gaynor, M.D., vice president of cancer research and global oncology platform leader for Lilly. “It brings us one step closer to offering a tailored treatment option that can potentially extend lives for non-small cell lung cancer patients with nonsquamous histology.”
The EU submission is based on data from a Phase III trial in which patients received pemetrexed or placebo to evaluate the overall survival benefit of pemetrexed in the maintenance NSCLC setting. This is the third trial to demonstrate that histology can be used to tailor treatment with other than predominantly squamous NSCLC. Full data from this trial are due to be presented at the forthcoming 45th Annual Meeting of the American Society of Clinical Oncology (ASCO), which is being held in Orlando, Florida from 29 May – 2 June 2009. The data will be delivered as an oral presentation at the meeting on 31 May at 9:00 a.m. EDT (Abstract # CRA8000).
Notes to Editor
About Non-Small Cell Lung Cancer (NSCLC)
NSCLC is the most common type of lung cancer and represents 85 to 90 percent of all lung cancers.(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.
According to the World Health Organization (WHO) Cancer Report, lung cancer is the world’s most common cancer and the leading cause of cancer death for men and women. More than 1 million people die from lung cancer each year.(6)
About Lilly Oncology, a Division of Eli Lilly and Company
For more than four decades, Lilly Oncology 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. Our quest is to develop a broad portfolio of tailored therapies that accelerate the pace and progress of cancer care.
About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class 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.
ALIMTA(R) (pemetrexed for injection), Lilly
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 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 or visit www.ALIMTA.com, or call 1-800-545-5979.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
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 products will receive additional regulatory approvals. There is also no guarantee that the products 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) 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.
(2) American Cancer Society, “What Is Non-Small Cell Lung Cancer?,” October 15, 2007, American Cancer Society, http://www.cancer.org/docroot/CRI/content/CRI_2_4_1x_What_Is_Non-Small_Cell_Lung_Cancer.asp?rnav=cri, (February 21, 2008).
(3) American Cancer Society. What is Non-Small Cell Lung Cancer? Available at: http://www.cancer.org/docroot/CRI/content/CRI_2_4_1x_What_Is_Non-Small_Cell_Lung_Cancer.asp?sitearea=. Accessed May 1, 2009.
(4) American Cancer Society, “What Is Non-Small Cell Lung Cancer?,” October
American Cancer Society, “What Is Non-Small Cell Lung Cancer?,” October 15, 2007, American Cancer Society, http://www.cancer.org/docroot/CRI/content/CRI_2_4_1x_What_Is_Non-Small_Cell_Lung_Cancer.asp?rnav=cri, (February 21, 2008).
(5) American Cancer Society, “How Is Non-Small Cell Lung Cancer Staged?” October 15, 2007, American Cancer Society, www.cancer.org/docroot/CRI/content/CRI_2_4_3x_How_Is_Non-Small_Cell_Lung_Cancer_Staged.asp?rnav=cri, (February 21, 2008).
(6) 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.