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Sept. 28, 2004 — The European Commission has approved the following drugs for use in the European Union: oxaliplatin in the adjuvant treatment of stage III colon cancer, efalizumab for moderate to severe chronic plaque psoriasis, pemetrexed in combination with cisplatin for malignant pleural mesothelioma, and pemetrexed monotherapy as second-line therapy for non-small cell lung cancer. In addition, the 2.5-kg pretreatment weight loss requirement has been removed from the label for orlistat.

Oxaliplatin (Eloxatin) for Adjuvant Treatment of Stage III Colon Cancer in EU

On Sept. 17, a successful completion of the Mutual Recognition Procedure in Europe resulted in an expanded indication for oxaliplatin (Eloxatin, made by Sanofi-Aventis), allowing its use in the European Union for the adjuvant treatment of stage III (Duke's C) colon cancer after complete resection of the primary tumor.

The approval was based on the phase III results of the Multicenter International Study of Oxaliplatin/5-Fluorouracil/Leucovorin (5-FU/LV) in the Adjuvant Treatment of Colon Cancer (MOSAIC) trial, showing that the addition of oxaliplatin to 5-FU/LV significantly increased disease-free survival at three years compared with 5-FU/LV alone (72.2% vs. 65.3%; 24% decrease in risk of recurrence) in patients with completely resected stage III colon cancer.

The addition of oxaliplatin to 5-FU/LV was well tolerated, neutropenia being the most frequently reported adverse effect and complicated by fever or infection in 1.8% of cases. Patients experiencing peripheral sensory neuropathy showed total or partial recovery within six months after treatment.

Oxaliplatin was previously approved in the EU and by the U.S. Food and Drug Administration for first- and second-line treatment of metastatic carcinoma of the rectum or colon. Approval for the extended indication is being applied for in the U.S. and in other countries.

Efalizumab (Raptiva) for Moderate to Severe Chronic Plaque Psoriasis in EU

On Sept. 23, the European Commission approved efalizumab (Raptiva, made by Serono) for use in the European Union. The drug is indicated in the treatment of adult patients with moderate to severe chronic plaque psoriasis in patients having inadequate or inappropriate response to other systemic treatments (cyclosporine, methotrexate) or phototherapy.

Efalizumab is a monoclonal antibody designed to selectively and reversibly block the activation, reactivation, and trafficking of T cells that lead to the development of psoriasis symptoms. It is administered by subcutaneous injection once weekly.

Efalizumab (Raptiva, made by Genentech) was approved by the U.S. Food and Drug Administration in October 2003 for the treatment of moderate to severe chronic plaque psoriasis in adults aged 18 years or older who are candidates for systemic therapy or phototherapy.

Pemetrexed (Alimta) for Malignant Pleural Mesothelioma and NSCLC in EU

On Sept. 22, the European Commission approved pemetrexed (Alimta, made by Lilly) for use in the European Union. Pemetrexed is indicated in combination with cisplatin for the treatment of malignant pleural mesothelioma in patients who have not received prior chemotherapy and are not candidates for surgery. Pemetrexed is administered with vitamin B12 and folic acid to reduce the frequency and severity of adverse effects without compromising its cytotoxic effects.

The approval was based on the results of a global clinical trial showing that the addition of pemetrexed to cisplatin increased overall survival by 30% (12.1 months vs 9.3 months) and one-year survival by 12.3% (50.3% vs. 38.0%) compared with cisplatin alone.

Adverse events associated with the drug combination include disorders of the blood and lymphatic system, gastrointestinal disorders, fatigue, nervous system sensory disorders, renal and urinary disorders, rash, and hair loss.

Pemetrexed was also approved in the EU as second-line monotherapy in the treatment of non-small cell lung cancer. The approval was based on the results of a phase III global clinical trial showing that pemetrexed demonstrated survival and overall response rates comparable to those of docetaxel, with a significantly improved adverse effect profile.

Pemetrexed was associated with a significantly decreased incidence of grade 3 or 4 neutropenia (5.3% vs 40.2%; P < .001), neutropenia with fever requiring hospitalization (1.5% vs 13.4%; P < .001), and hair loss (6.4% vs 37.7%; P < .001) compared with docetaxel, although increased transient elevations in alanine transaminase were noted (1.9% vs 0.0%; P = .028).

Adverse events for pemetrexed used as a second-line monotherapy for non-small cell lung cancer included disorders of the blood and lymphatic system, gastrointestinal disorders, fatigue, rash, and desquamation.

Pemetrexed is currently approved by the U.S. Food and Drug Administration in the treatment of locally advanced or metastatic non-small cell lung cancer after prior chemotherapy, and for use in combination with cisplatin in the treatment of malignant pleural mesothelioma.

Pretreatment Weight-Loss Requirement Removed From Orlistat (Xenical) Label in EU

On Sept. 21, the European Commission approved the use of orlistat (Xenical, made by Roche) in an expanded population by removing the 2.5-kg pretreatment weight-loss requirement from the European label. This allows physicians in the European Union to provide patients with immediate access to treatment.

The requirement was originally intended to help physicians identify patients most likely to respond to treatment; it was rescinded based on the results of studies showing that weight loss after three months of orlistat therapy is the best predictor of weight loss at one year.

Orlistat is currently approved by the U.S. Food and Drug Administration for use in obesity management, including weight loss and weight maintenance when used in conjunction with a reduced-calorie diet. The U.S. label does not include a pretreatment weight-loss requirement.

Reviewed by Gary D. Vogin, MD

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