Alimta (Pemetrexed Disodium) - Summary

ALIMTA SUMMARY

ALIMTA^® , pemetrexed for injection, is an antifolate antineoplastic agent that exerts its action by disrupting folate-dependent metabolic processes essential for cell replication. Pemetrexed disodium heptahydrate has the chemical name L-Glutamic acid, N -[4-[2-(2-amino-4,7-dihydro-4-oxo-1 H -pyrrolo[2,3- d ]pyrimidin-5-yl)ethyl]benzoyl]-, disodium salt, heptahydrate.

Mesothelioma: ALIMTA in combination with cisplatin is indicated for the treatment of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery.

Non-Small Cell Lung Cancer: ALIMTA as a single-agent is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after prior chemotherapy.

The effectiveness of ALIMTA in second-line NSCLC was based on the surrogate endpoint, response rate. There are no controlled trials demonstrating a clinical benefit, such as a favorable survival effect or improvement of disease-related symptoms.

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NEWS HIGHLIGHTS

Media Articles Related to Alimta (Pemetrexed)

Lung Cancer: Expanded Alimta Label
Source: MedPage Today Product Alert [2012.10.19]
WASHINGTON -- The FDA has expanded the indication for the cancer drug pemetrexed injection to act as a maintenance therapy with cisplatin for nonsquamous non-small cell lung cancer.

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Published Studies Related to Alimta (Pemetrexed)

Pemetrexed in combination with cisplatin versus cisplatin monotherapy in patients with recurrent or metastatic head and neck cancer: final results of a randomized, double-blind, placebo-controlled, phase 3 study. [2012]
pemetrexed-cisplatin for SCCHN... CONCLUSIONS: Pemetrexed-cisplatin compared with placebo-cisplatin did not

Quality of life in patients with advanced non-small-cell lung cancer given maintenance treatment with pemetrexed versus placebo (H3E-MC-JMEN): results from a randomised, double-blind, phase 3 study. [2012]
palliation, and tolerability are presented here... INTERPRETATION: Quality of life during maintenance therapy with pemetrexed is

A phase II randomized study of cisplatin-pemetrexed plus either enzastaurin or placebo in chemonaive patients with advanced non-small cell lung cancer. [2012]
non-small cell lung cancer (NSCLC)... CONCLUSIONS: Enzastaurin and cisplatin-pemetrexed is tolerable with preliminary

Efficacy and safety of pemetrexed maintenance therapy versus best supportive care in patients from East Asia with advanced, nonsquamous non-small cell lung cancer: an exploratory subgroup analysis of a global, randomized, phase 3 clinical trial. [2012]
non-East Asian patients treated with pemetrexed or placebo... CONCLUSION: The results of this subgroup analysis support pemetrexed as

Comparison of pemetrexed plus cisplatin with other first-line doublets in advanced non-small cell lung cancer (NSCLC): A combined analysis of three phase 3 trials. [2011.11.22]
INTRODUCTION: In a first-line study of advanced NSCLC, pemetrexed-cisplatin was more effective among patients with adenocarcinoma and large-cell carcinoma compared with gemcitabine-cisplatin (median survival of 11.8 versus 10.4 months, P=.005), while survival with pemetrexed-cisplatin was shorter than with gemcitabine-cisplatin in patients with squamous cell carcinoma. The comparability of pemetrexed-cisplatin to other commonly used regimens within histology subgroups needs to be explored... CONCLUSION: In the absence of randomized clinical trial data comparing pemetrexed-cisplatin to commonly used doublets in advanced NSCLC other than gemcitabine-cisplatin, this combined analysis of multiple trials provides estimates for such comparisons. Copyright (c) 2011 Elsevier Ireland Ltd. All rights reserved.

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Clinical Trials Related to Alimta (Pemetrexed)

Efficacy Study Comparing ZD6474 in Combination With Pemetrexed and Pemetrexed Alone in 2nd Line NSCLC Patients [Active, not recruiting]
Non-small cell lung cancer (NSCLC) can be treated with drugs that kill tumour cells, stop them from dividing, or stop the growth of the blood supply that cancers need to grow and spread. Clinical research has shown that drugs that inhibit vascular endothelial growth factor receptor (VEGFR) or epidermal growth factor receptor (EGFR) signalling can increase overall survival in patients with advanced non-small cell lung cancer (NSCLC). Preclinical studies have shown that vandetanib (ZD6474) is an inhibitor of both VEGFR and EGFR signalling. Giving vandetanib may therefore inhibit the growth of cancer cells by blocking their blood supply and by stopping them from dividing. This lung cancer study is to investigate if adding vandetanib to Alimta (pemetrexed) is more effective than Alimta (pemetrexed) alone.

Study of Alimta® (Pemetrexed) Plus VELCADE® (Bortezomib) or Alimta Alone or VELCADE Alone in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Prior Therapy [Completed]
The purpose of this study is to establish the objective response rate (complete response + partial response), following treatment with Alimta plus VELCADE, Alimta alone, or VELCADE alone in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have failed prior preventative therapy for Stage IIIb/IV NSCLC. The Alimta alone treatment group will be used as the control. The VELCADE single-agent treatment group will be used to determine if VELCADE administered weekly can demonstrate response rates.

ZD6474(Vandetanib) + Alimta Combo Study [Active, not recruiting]
The main purpose of this trial is to look to see if adding ZD6474 (100 mg or 300mg tablets) to Alimta chemotherapy in patients with non-small cell lung cancer is safe and will help control their symptoms and disease better than the chemotherapy alone.

A Phase 3 Trial of ALIMTA (LY231514, Pemetrexed) Plus GEMZAR Versus GEMZAR in Patients With Unresectable or Metastatic Cancer of the Pancreas. [Completed]
Definition: This study will compare the drug GEMZAR to a combination of GEMZAR plus ALIMTA for the treatment of cancer of the pancreas. Patients may be able to participate in this study if they have cancer in their pancreas that cannot be removed by surgery OR that has spread to a new site in their body.

Trial of Pemetrexed With or Without PF-3512676 in Advanced Non-Small Cell Lung Cancer [Completed]
To assess the efficacy and safety of PF-3512676 administered in combination with pemetrexed for the treatment of patients with locally advanced or metastatic NSCLC who have failed one prior chemotherapy regimen

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Reports of Suspected Alimta (Pemetrexed) Side Effects

Death (116),  Neoplasm Progression (81),  Thrombocytopenia (53),  Dyspnoea (49),  Diarrhoea (49),  Interstitial Lung Disease (47),  Anaemia (45),  Pancytopenia (37),  Neutropenia (34),  Pyrexia (33), more >>