News Release

INDIANAPOLIS, Oct. 28, 2011 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the European Commission has granted approval for the use of ALIMTA® (pemetrexed for injection) as a single agent for continuation maintenance therapy in patients with a particular type of lung cancer, called advanced nonsquamous non-small cell lung cancer (NSCLC). The approval is based on clinical trial results showing an improvement in progression-free survival, as well as a preliminary analysis showing a strong trend toward better overall survival, for NSCLC patients treated first with ALIMTA plus cisplatin and then continue treatment with ALIMTA alone in the maintenance setting.

ALIMTA is the first chemotherapy agent to be approved in Europe for continuation maintenance therapy. In this setting, patients whose disease has not progressed immediately following first-line treatment with ALIMTA plus cisplatin can continue maintenance treatment with ALIMTA alone and achieve additional benefit.

Continuation maintenance therapy with ALIMTA is specifically tailored to benefit the group of patients with a particular type of NSCLC, called nonsquamous, and who have shown a positive response or disease stabilization after treatment with first-line ALIMTA plus cisplatin. Although other maintenance regimens are currently available for NSCLC, they involve using different medicines in the maintenance phase of treatment than were used in the first-line setting.

"This latest approval for ALIMTA represents an important advance in the treatment of advanced lung cancer," said Allen Melemed, M.D., M.B.A., senior medical director with Lilly Oncology. "Tailored therapies have come to the forefront of cancer treatment because they allow clinicians to select the right treatment for the right patient. With ALIMTA continuation maintenance therapy, patients with lung cancer who have already benefited from first-line treatment will now have the option to continue treatment with ALIMTA, with the goal of a better clinical outcome."

Approval of ALIMTA continuation maintenance was based on results from PARAMOUNT, a randomized double-blind Phase III study presented in June 2011 at the American Society of Clinical Oncology (ASCO) Annual Meeting.(1) The study examined whether ALIMTA continuation maintenance therapy improves progression-free survival, as well as overall survival, after ALIMTA-cisplatin induction therapy in patients with advanced nonsquamous NSCLC. The study met its primary endpoint of progression-free survival, and a preliminary analysis has shown a strong trend toward positive overall survival.  

Patients received standard induction therapy with four cycles of ALIMTA (500 mg/m2) and cisplatin (75 mg/m2) on a 21-day cycle. Of the 939 patients with advanced nonsquamous NSCLC who were enrolled and received induction therapy, 539 non-progressers with a good performance status were subsequently randomized to receive one of two maintenance therapy regimens. They received either ALIMTA (500 mg/m2 on day one of a 21-day cycle) plus best supportive care (n=359), or placebo plus best supportive care (n=180) until disease progression. All patients received vitamin B12, folic acid and dexamethasone.

ALIMTA is approved in Europe and the U.S. for three indications in patients with advanced nonsquamous NSCLC, including first-line treatment in combination with cisplatin, second-line treatment, and maintenance treatment of patients whose disease has not progressed immediately following platinum-based chemotherapy.

ALIMTA is also approved, in combination with cisplatin, in both the EU and U.S. for the treatment of chemotherapy-naïve patients with unresectable malignant pleural mesothelioma.

Notes to Editor

About Maintenance Treatment in 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. No other chemotherapy is currently approved in the "continuation maintenance" setting, in which one of the same medicines used in first-line treatment is continued as maintenance therapy. Previously approved maintenance therapies in lung cancer use different medicines in the first-line and maintenance phases of treatment.

About NSCLC

Globally, lung cancer is the most common form of cancer and the biggest killer, causing 1.3 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,(4) 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. To learn more about Lilly's commitment to cancer, please visit www.LillyOncology.com.

About Eli Lilly and Company

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.

P-LLY

ALIMTA® (pemetrexed for injection), Lilly

Indications and Important Safety Information

Indications

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.

Important Safety Information for ALIMTA® (pemetrexed for injection)

What is the most important information that I should know about ALIMTA?

ALIMTA can suppress bone marrow function, which may cause low blood cell counts.

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 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.

Your doctor will prescribe a medicine called a "corticosteroid" to take for 3 days during each treatment with ALIMTA. Corticosteroids lower your chances for getting skin reactions with ALIMTA.

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.

• You must take folic acid every day for at least 5 days out of the 7 days before your first dose of ALIMTA. You must keep taking folic acid every day during the time you are getting treatment with ALIMTA, and for 21 days after your last treatment.

• Your doctor will give you vitamin B12 injections while you are getting treatment with ALIMTA. You will get your first vitamin B12 injection during the week before your first dose of ALIMTA, and then about every 9 weeks during treatment.

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.

What should I tell my doctor before receiving ALIMTA?

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.

Tell your doctor if you are taking other medicines, including prescription and nonprescription medicines, vitamins, and herbal supplements. ALIMTA and other medicines may affect each other, causing serious side effects. Especially, tell your doctor if you are taking medicines called "nonsteroidal anti-inflammatory drugs" (NSAIDs) for pain or swelling.

What are the possible side effects of ALIMTA?

Most patients taking ALIMTA will have side effects. Sometimes it is not always possible to tell whether ALIMTA, another medicine, or the cancer itself is causing these side effects.

Call your doctor right away if you have a fever, chills, diarrhea, or mouth sores. These symptoms could mean you have an infection, which may be severe and could lead to death.

The most common side effects of ALIMTA when given alone or in combination with cisplatin are:

• Stomach upset, including nausea, vomiting, diarrhea, or constipation. You can obtain medicines to help control some of these symptoms. Call your doctor if you get any of these symptoms.

• Low blood cell counts:

Low red blood cells. Low red blood cells may make you feel tired, get tired easily, appear pale, and become short of breath.

Low white blood cells. Low white blood cells may give you a greater chance for infection. If you have a fever (temperature above 100.4 degrees F) or other signs of infection, call your doctor right away.

Low platelets. Low platelets give you a greater chance for bleeding. Your doctor will do blood tests to check your blood counts before and during treatment with ALIMTA.

• Tiredness. You may feel tired or weak for a few days after your ALIMTA treatments. If you have severe weakness or tiredness, call your doctor.

• Mouth, throat, or lip sores (stomatitis, pharyngitis). You may get redness or sores in your mouth, throat, or on your lips. These symptoms may happen a few days after ALIMTA treatment. Talk with your doctor about proper mouth and throat care.

• Loss of appetite. You may lose your appetite and lose weight during your treatment. Talk to your doctor if this is a problem for you.

• Rash. You may get a rash or itching during treatment. These usually appear between treatments with ALIMTA and usually go away before the next treatment. Rarely, these reactions may be severe (can lead to Stevens-Johnson syndrome or toxic epidermal necrolysis) and could lead to death. Call your doctor if you get a severe rash, itching, or blistering.

Talk with your doctor, nurse, or pharmacist about any side effect that bothers you or that doesn't go away.

These are not all the side effects of ALIMTA. For more information, ask your doctor, nurse, or pharmacist.

How is ALIMTA given?

ALIMTA is slowly infused (injected) into a vein. The injection or infusion will last about 10 minutes. You will usually receive ALIMTA once every 21 days (3 weeks).

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 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 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, Dediu M, 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, 2003, 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, (October 20, 2011).

(4)  American Cancer Society, "What Is Non-Small Cell Lung Cancer?," October 20, 2009, American Cancer Society, http://www.cancer.org/Cancer/LungCancer-Non-SmallCell/DetailedGuide/non-small-cell-lung-cancer-what-is-non-small-cell-lung-cancer, (October 20, 2011)..

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SOURCE Eli Lilly and Company