Alimta - pemetrexed
What is Alimta?
Alimta is a powder that is made up into a solution for infusion (drip injection). Contains the active substance pemetrexed.
What is Alimta used for?
Alimta is indicated for the treatment of patients with two types of cancers that affect the lungs:
- pleural mesothelioma (cancer of the membrane that lines 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 other parts of the body). It is used to treat patients who have not previously received chemotherapy (medicines to treat cancer);
- "non-small cell" lung cancer that does not affect "squamous" cells (the cells that line the airways). Alimta is used when the cancer is 'locally advanced' (has started to spread) or 'metastatic' (has already spread to other parts of the body). It is used in combination with cisplatin to treat previously untreated patients. 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 administered under the supervision of a physician 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 vitamin B12 injections while taking Alimta. When Alimta is given with cisplatin, patients should take an 'antiemetic' medicine (to prevent vomiting) and fluids (to prevent dehydration) before or after taking cisplatin.
Treatment should be postponed or stopped, or the dose reduced, in patients with abnormal blood counts or who report other side effects. For more information, see the Summary of Product Characteristics (also part of the EPAR).
How does Alimta work?
The active substance in Alimta, pemetrexed, is a cytotoxic medicine (a medicine that kills actively dividing cells, such as cancer cells) that belongs 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" (building blocks of DNA and RNA, the genetic material of cells). As a result, the active form of pemetrexed slows down the formation of DNA and RNA and prevents cell division. The conversion of pemetrexed to its active form occurs more rapidly in cancer cells than in normal cells; for this reason, in the tumor cells there are higher concentrations of the active form of the drug and a more prolonged action. Consequently, the proliferation of tumor cells is reduced, while normal cells are only minimally affected.
How has Alimta been studied?
For the treatment of malignant pleural mesothelioma, Alimta combined with cisplatin was compared with cisplatin alone in one main study involving 456 patients who had not received chemotherapy before.
For the treatment of locally advanced or metastatic non-small cell carcinoma, Alimta was compared with gemcitabine (another anticancer medicine), both in combination with cisplatin, in a study involving 1,725 patients who had previously received chemotherapy. Alimta was also compared with docetaxel (another anticancer medicine) in a study involving 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 gotten worse during platinum-based chemotherapy.
The main measures of effectiveness were the patients' survival time and the survival time interval without tumor worsening.
What benefit has Alimta shown during the studies?
Alimta increased the survival time of patients with malignant pleural mesothelioma. Those who received Alimta and cisplatin survived an average of 12.1 months, compared with 9.3 months for patients who took cisplatin alone.
In the treatment of non-small cell lung cancer, Alimta proved to be as effective as comparators, with survival times of about 10.3 months in patients who had never undergone chemotherapy and about 8.1 months in those who had previously been undergoing chemotherapy. In the maintenance treatment study, patients receiving Alimta lived for an additional 4.3 months from the start of maintenance treatment without their cancer getting worse, compared with 2.6 months for those taking placebo. In all three patients. studies, patients whose cancer did not involve squamous cells reported longer survival times when treated with Alimta rather than the comparator. Instead, patients whose cancer did not involve 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 in 10 patients) are reduction in the number of neutrophils, granulocytes or leukocytes (types of white blood cells), decrease in hemoglobin levels (the protein in red blood cells that carries the "oxygen in the body"), diarrhea, vomiting, stomatitis or pharyngitis (inflammation of the mucous membranes that cover 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 side effects reported with Alimta, see the package leaflet.
Alimta must not be used in people who may be hypersensitive (allergic) to pemetrexed or any of the other ingredients. It should not be used while breastfeeding or at the same time as yellow fever vaccine. Alimta impairs fertility, therefore patients (men and women) taking the drug should be aware of this.
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 non-pretreated patients with unresectable malignant pleural mesothelioma, and for first-line maintenance and second-line treatment. line for patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. The committee recommended the granting of a marketing authorization for Alimta.
More information about Alimta
On 20 September 2004, the European Commission issued Eli Lilly Nederland B.V. a "marketing authorization" for Alimta, valid throughout the European Union.
The marketing authorization was renewed on 20 September 2009.
For the full version of Alimta's EPAR, click here.
Last update of this summary: 09-2009
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