GSK Hycamtin cervical cancer sNDA
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
GlaxoSmithKline's sNDA for use of its topoisomerase inhibitor Hycamtin (topotecan) in combination with cisplatin for second-line treatment of recurrent or persistent cervical cancer will receive a priority review, the firm announces Feb. 17. The application has a June 15 action date. The sNDA is based on a single Phase III study of 147 women treated with Hycamtin plus cisplatin compared with 146 patients on cisplatin alone. The trial found a statistically significant improvement in median overall survival of 9.4 months for Hycamtin/cisplatin versus 6.5 months for cisplatin alone...