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Alimta (Pemetrexed). Presented By: Rachael Germansky. Overview. Alimta Overview Cancer Lung Cancer Mesothelioma Alimta Alimta and Cisplatin Future Applications . Alimta. Chemotherapy drug that interferes with folic acid production to stop the spread of cancer cells
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Alimta (Pemetrexed) Presented By: Rachael Germansky
Overview • Alimta Overview • Cancer • Lung Cancer • Mesothelioma • Alimta • Alimta and Cisplatin • Future Applications
Alimta • Chemotherapy drug that interferes with folic acid production to stop the spread of cancer cells • Alimta/Cisplatin improved survival for pleural mesothelioma patients by approximately three months • Only drug approved by the FDA for the treatment of patients with mesothelioma when surgery is not an option
Cancer • Cells become abnormal and rapidly form in an uncontrolled way - form a mass of tissue (tumor) • Tumors can either be malignant or benign • Malignant tumors • Invade surrounding tissue via bloodstream • Metastasis • Benign tumors • Removed with surgery • Usually do not recur • Do not metastasize
Lung Cancer • 177,000 cases annually • #1 cause of cancer-related deaths • Small cell lung cancer (SCLC) • More aggressive type of lung cancer • 15-20% • Is more responsive to chemotherapy • Frequently found in smokers or former smokers • Non-small cell lung cancer (NSCLC) • 75- 80% • 3 types
NSCLC • Diagnosis - Chest x-ray, CT and MRI scans, PET scans, Sputum cytology, Biopsy • Stages • Stage I - confined to lung tissue alone • Stage II - lung tissue and lymph nodes in lung • Stage III - lung tissue and lymph nodes outside of the lung • Stage IV - distant spread (liver, adrenal glands, bone, brain, other sites) • Treatments – Surgery, Chemotherapy, Radiation therapy, Immunotherapy
Mesothelioma http://www.alimta.com/understanding/mesothelioma/index.jsp?reqNavId=1.2 • Arises in the mesothelium • Long time to develop • Rare disease • Occurs in men more • Occurs mostly on the lungs • 75-80% caused by asbestos exposure http://www.alimta.com/understanding/causes.jsp?reqNavId=1.2.2
Mesothelioma • Diagnosis - Chest x-ray, CT and MRI scans, Thoracentesis, Biopsy • Stages • Localized (Stage I) • Advanced (Stage II, III, IV) • Treatments – Surgery, Chemotherapy, Radiation therapy
Alimta • Approved by the FDA February 5, 2004 to treat Mesothelioma and NSCLC • Eli Lilly and Company
Development of Alimta • Folic acid is a B-vitamin body uses to build cells • Folic acid can stimulate tumor growth • Leukemia - folic acid increased the growth and numbers of cancer cells • Theorized that compounds that interfered with folic acid production could fight cancer
How Does it Work? • Multi-targeted antifolate drug • “Targets the folic acid metabolic pathway, which effects availability of certain B complex vitamins." • Folic acid antagonist - reduces ability of folic acid to enhance the spread of tumors. • Blocks DNA copying and cell division
Pharmacokinetics • Dose 500 mg/m2 over 10 minutes • Not appreciable metabolized • 70-90% leaves in urine • Systemic clearance 91.8 L/min • Half-life 3.5 hours • 81% bound to plasma proteins
Administration • Mesothelioma - with cisplatin (platinum agent) • 30 minutes after the ALIMTA infusion cisplatin administered by IV infusion over 2 hours • NSCLC - alone • 21-day cycle • IV infusion over 10 minutes • 500 mg/m2 • Folic acid pill once per day • Intramuscular shot of vitamin B12 • Oral steroid medication called dexamethasone
Side Effects • Upset stomach • Nausea • Vomiting • Diarrhea • Low blood cell counts • Red blood cells • White blood cells • Platelets • Tiredness • Mouth sores • Loss of appetite • Rash
Alimta and Cisplatin • The Alimta/Cisplatin chemotherapy regimen is the first Food and Drug Administration (FDA) approved treatment specifically for malignant pleural mesothelioma. This is currently considered the most effective first-line treatment for mesothelioma patients who are not surgical candidates.
Alimta/Cisplatin vs. Cisplatin http://pi.lilly.com/us/alimta-pi.pdf
Cost of Treatment • $300-500,000 • Each injection of Alimta costs $2000+ • If asbestos exposure can be proven entitled to compensation ($1,000-1,000,000)
Future Applications • Ongoing Clinical Tests • Treat solid tumors • Breast • Colorectal • Pancreatic • Gastric • Bladder • Cervical
References • http://www.alimta.com • http://www.cancer.gov/clinicaltrials/results/mesothelioma-study0502/print?page=&keyword= • http://www.rxlist.com/cgi/generic3/alimta_cp.htm • http://www.lexi.com/web/content/newdrugs/chapter/mono/newdrugsdisp.jsp?id=hf097072 • http://pi.lilly.com/us/alimta-ppi.pdf