Pemetrexed for injection


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Company: Eli Lilly
Approval Status: FDA/EMA Approved February 2004
Specific Treatments: Mesothelioma
Drug: Pemetrexed for injection


General Information

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 surgery.

The recommended dosage is 500 mg/m2 administered as an intravenous infusion over 10 minutes on Day 1 of each 21-day cycle.


Clinical Results

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.


Side Effects

Adverse events associated with the use of Alimta may include (but are not limited to) the following:

  • Hematologic effects
  • Fatigue
  • Fever
  • Infection
  • Stomatitis
  • Pharyngitis
  • Rash


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.


Literature References

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 Rep. 2003;5:334-341.

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 5.

Source: centerwatch