What is Alimta?
Alimta is a powder that is made up into a solution for infusion (drip). Contains the active ingredient pemetrexed.
What is Alimta used for?
Alimta is indicated for the treatment of patients with two types of lung cancer:
- pleural mesothelioma (a tumor of the membrane that covers the lungs, generally caused by exposure to asbestos). Alimta is used in combination with cisplatin (another anticancer medicine) when the tumor is not "resectable" (it cannot be removed by surgery alone) and is "malignant" (it has spread, or is likely to spread easily, to others parts of the body). It is indicated to treat patients who have not previously undergone chemotherapy (medicines for the treatment of tumors);
- "non-small cell" lung cancer that does not affect "scaly" cells (the cells that line the respiratory tract). Alimta is used when the tumor is "locally advanced" (it has started to spread) or "metastatic" (it has already spread to other parts of the body). It is used in combination with cisplatin to treat patients who have not been treated before. Alimta is also indicated on its own to treat patients who have already completed a course of chemotherapy, or to maintain the response to a first course of chemotherapy including a medicine that contains platinum.
The medicine can only be obtained with a prescription .
How is Alimta used?
Alimta should only be given under the supervision of a doctor who is qualified in the use of chemotherapy.
The recommended dose of Alimta is 500 mg per square meter of body surface area (calculated based on the patient's weight and height) to be administered by infusion over 10 minutes once every three weeks. To reduce side effects, patients should take a corticosteroid (a type of medicine that reduces inflammation) and folic acid (a type of vitamin) and receive injections of vitamin B12 during treatment with Alimta. When Alimta is given with cisplatin, patients should take an "anti-emetic" drug (to prevent vomiting) and fluids (to prevent dehydration) before or after taking cisplatin.
Treatment should be postponed or suspended, or the dose reduced, in patients with changes in blood counts or other side effects. For further information, please refer to the summary of product characteristics (also included with the EPAR).
How does Alimta work?
The active substance in Alimta, pemetrexed, is a cytotoxic medicine (a medicine that kills cells in active division, such as cancer cells) belonging to the group of antimetabolites. In the body, pemetrexed is converted into an active form that blocks the activity of enzymes involved in the production of "nucleotides" (constituent elements of DNA and RNA, the genetic material of cells). As a result, the active form of pemetrexed slows DNA and RNA formation and prevents cell division. The conversion of pemetrexed into its active form occurs more rapidly in tumor cells than in normal ones; for this reason, in tumor cells there are higher concentrations of the active form of the drug and more prolonged action. As a result, tumor cell proliferation is reduced, while normal cells are only minimally affected.
What studies have been carried out on Alimta?
For the treatment of malignant pleural mesothelioma, Alimta associated with cisplatin was compared with cisplatin alone in a main study involving 456 patients who had not undergone chemotherapy previously.
For the treatment of non-small, locally advanced or metastatic small cell carcinoma, Alimta was compared with gemcitabine (another anticancer medicine), both in combination with cisplatin, in a study of 1, 725 patients who had undergone chemotherapy before. Alimta was also compared to docetaxel (another anticancer medicine) in a study of 571 patients who had previously received chemotherapy. For maintenance treatment, Alimta was compared with placebo (a dummy treatment) in one main study involving 663 patients whose cancer had not worsened during platinum-based chemotherapy.
The main indicators of effectiveness were the survival time of the patients and the interval of survival time without worsening the tumor.
What benefit has Alimta shown during the studies?
Alimta has increased the survival period of patients with malignant pleural mesothelioma. Subjects given Alimta and cisplatin survived for an average of 12.1 months, compared with 9.3 months in patients receiving cisplatin alone.
In the treatment of non-small cell lung cancer, Alimta proved to be as effective as the comparators, with survival times of approximately 10.3 months in patients who had never undergone chemotherapy and about 8.1 months in those who had previously been subjected to chemotherapy. In the maintenance treatment study, patients who received Alimta lived for an additional 4.3 months from the start of maintenance treatment without worsening the tumor, compared to 2.6 months for those treated with placebo. In all three studies, patients whose tumors did not affect squamous cells reported longer survival times when treated with Alimta instead of comparator. Instead, patients whose cancer affected squamous cells reported shorter survival times when treated with Alimta.
What is the risk associated with Alimta?
The most common side effects seen with Alimta (seen in more than 1 patient in 10) are reduction in the number of neutrophils, granulocytes or leukocytes (types of white blood cells), decreased levels of hemoglobin (the protein contained in the red blood cells that conveys the 'oxygen in the body), diarrhea, vomiting, stomatitis or pharyngitis (inflammation of the mucous membranes covering the mouth or throat), nausea, loss of appetite, fatigue and rash or peeling (flaking of the upper layers of the skin). For the full list of all side effects reported with Alimta, see the Package Leaflet.
Alimta should not be used in people who may be hypersensitive (allergic) to pemetrexed or any of the other ingredients. It should not be used during breastfeeding or at the same time as the yellow fever vaccine. Alimta alters fertility, so patients (men and women) taking the drug must be aware of this fact.
Why has Alimta been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that Alimta's benefits are greater than its risks for the chemotherapy treatment of untreated patients with unresectable malignant pleural mesothelioma, and for the first line, maintenance and second treatment line for patients with non-small cell lung cancer, locally advanced or metastatic, other than with histology mainly squamous cell. The committee recommended that Alimta be given marketing authorization.
More information on Alimta
On 20 September 2004, the European Commission issued a marketing authorization valid for Alimta to Eli Lilly Nederland BV, valid throughout the European Union.
The marketing authorization was renewed on 20 September 2009.
For the full EPAR for Alimta, click here .
Last update of this summary: 09-2009
