Issue Date: June 7, 2004
Conditional green light for Allos drug
FDA has granted Allos Therapeutics conditional approval for RSR13 (efaproxiral), a drug that treats brain metastases originating from breast cancer. Approval is dependent on results of an ongoing Phase III clinical trial and inspection of Allos' manufacturing facility. The nod is a surprise, given that last month an FDA committee recommended against approval of RSR13, expressing concerns that a previous clinical test on a non-cancer-specific test group involved too few patients with breast cancer (C&EN, May 10, page 12). RSR13 is manufactured for Allos under contract by Hovione.
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