Hycamtin Approved For Ovarian Cancer

July 1, 1996

PHILADELPHIA--SmithKline Beecham's Hycamtin (topotecan) has received marketing clearance from the FDA for the treatment of patients with metastatic ovarian cancer after failure of initial or subsequent chemotherapy. It is the first topoisomerase I inhibitor approved for use in the United States.

PHILADELPHIA--SmithKline Beecham's Hycamtin (topotecan) has receivedmarketing clearance from the FDA for the treatment of patientswith metastatic ovarian cancer after failure of initial or subsequentchemotherapy. It is the first topoisomerase I inhibitor approvedfor use in the United States.

Hycamtin is currently available in pharmacies and will receiveits official launch by SmithKline shortly. (Look for a New Productreport next month).

The approval was based in part on results from an open, randomizedcomparative study showing that patients treated with Hycamtinhad a significantly longer progression-free survival than patientstreated with paclitaxel (Taxol) and a numerically superior responserate.

[For a more detailed discussion of the pivotal trials, see OncologyNews International, May, 1996,"Panel Recommende HycamtinApproval for Ovarian Cancer".]