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Genzyme Clolar Approved For Pediatric Acute Lymphoblastic Leukemia

This article was originally published in The Pink Sheet Daily

Executive Summary

Indication follows advisory committee recommendation to approve clofarabine for ALL but not for pediatric acute myelogenous leukemia. Genzyme will have to redesign its confirmatory trial within two months.

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Genzyme Clolar Confirmatory Pediatric Study Should Enroll Early Relapse Leukemia Patients, Cmte. Says

Focus on earlier stage disease would enlarge potential pediatric population for study. FDA’s Oncology Pediatric Subcommittee also recommends that primary trial endpoints include remission induction rate.

Genzyme Clolar Confirmatory Pediatric Study Should Enroll Early Relapse Leukemia Patients, Cmte. Says

Focus on earlier stage disease would enlarge potential pediatric population for study. FDA’s Oncology Pediatric Subcommittee also recommends that primary trial endpoints include remission induction rate.

Genzyme's Clolar Treatment Priced At $90,000 For An Average Patient

Clofarabine carries an average wholesale price of $2,812.50 per 20 mL vial, according to Medi-Span's Price Alert. Assuming no rebates, annual revenues for the product could be in the range of $45 mil.-$90 mil.

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