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Medical Areas: Oncology
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Alimta (pemetrexed for injection)
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Eli Lilly
Approval Status: Approved February 2004
Treatment Area: Mesothelioma
Alimta (pemetrexed) is a chemotherapy drug that interferes with
three folic acid related enzymes that work feed the cancer cell,
the process that allows mesothelioma cells to spread.
Alimta is indicated, in combination with cisplatin, for the
treatment of malignant pleural mesothelioma whose disease is
unresectable or who are otherwise not candidates for curative
The recommended dosage is 500 mg/m2 administered as an
intravenous infusion over 10 minutes on Day 1 of each 21-day
FDA approval of Alimta was based on a multi-center, randomized,
single-blind study enrolling 448 chemonaive subjects with Malignant
Pleural Mesothelioma (MPM). The study compared survival in subjects
treated with Alimta in combination with cisplatin to cisplatin
alone. Subjects received Alimta intravenously over 10 minutes at a
dose of 500 mg/m2 and cisplatin was administered intravenously over
2 hours at a dose of 75 mg/. Some patients were given folic acid
and vitamin B12 supplementation.
Results from the trial demonstrated an objective tumor response
rate for Alimta plus cisplatin that was greater than the objective
tumor response rate for cisplatin alone. Data showed that the
median overall survival for subjects treated with Alimta plus
cisplatin were 12.1 months compared with 9.3 months with cisplatin
alone. Subjects given supplements of folic acid and vitamin B12
showed a 13.3 months median survival rate with the combination
treatment compared with 10.0 months with cisplatin alone.
Adverse events associated with the use of Alimta may include
(but are not limited to) the following:
- Hematologic effects
Mechanism of Action
Pemetrexed is an antifolate antineoplastic agent that exerts its
action by disrupting folate-dependent metabolic processes essential
for cell replication. In cancer subjects, folic acid can stimulate
tumor growth. Alimta is a folic acid antagonist, which reduces the
ability of folic acid to enhance the spread of tumors. Specifically
the drug inhibits thymidylate synthase, dihydrofolate reductase,
and glycinamide ribonucleotide formyltransferase.
Gralla RJ, Hollen PJ, Liepa AM, et al.
Improving quality of life in patients with malignant pleural
mesothelioma: results of the randomized pemetrexed + cisplatin vs
cisplatin trial using the LCSS-meso instrument. Proc Am Soc
Clin Oncol. 2003;22:621. Abstract 2496.
Khalil MY, Mapa M, Shin HJ, Shin DM. Advances
in the management of malignant mesothelioma. Curr Oncol
Manegold C, Symanowski J, Gatzemeier U, et al.
Secondary (post-study) chemotherapy in the phase III study of
pemetrexed + cisplatin vs. cisplatin in malignant pleural
mesothelioma is associated with longer survival. Proc Am Soc
Clin Oncol. 2003;22:667. Abstract 2684.
Vogelzang NJ, Rusthoven J, Paoletti P, et al.
Phase III single-blinded study of pemetrexed + cisplatin vs.
cisplatin alone in chemonaive patients with malignant pleural
mesothelioma. Proc Am Soc Clin Oncol. 2002;21:6a. Abstract
For additional information regarding Alimta or Mesothelioma,
please contact The
Alimta Web Site