BTG plc: Orphan Drug status granted for anticancer drug plevitrexed
BTG Plc announced that its cancer drug plevitrexed (BGC 9331) has been granted US Orphan Drug Designation for ovarian and gastric cancer indications.
Plevitrexed is a potent, selective thymidylate synthase inhibitor targeting gastric, pancreatic and ovarian cancers. In January 2007, the results of Phase I/II study to investigate the efficacy, safety and tolerability of plevitrexed in patients with advanced and/or metastatic gastric cancer were presented at the ASCO gastrointestinal cancers symposium. The overall efficacy of plevitrexed was in line with other single agent therapy and with that of the two-drug combination cisplatin plus 5-FU as reported in a recent study. The progression-free survival and median overall survival were similar for plevitrexed and for those reported in the cisplatin plus 5-FU combination study, but plevitrexed showed less toxicity and in particular less neutropenia. To date, plevitrexed has been investigated in more than 1,000 patients.
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