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.
Hycamtin is currently available in pharmacies and will receive its official launch by SmithKline shortly. (Look for a New Product report next month).
The approval was based in part on results from an open, randomized comparative study showing that patients treated with Hycamtin had a significantly longer progression-free survival than patients treated with paclitaxel(Drug information on paclitaxel) (Taxol) and a numerically superior response rate.
[For a more detailed discussion of the pivotal trials, see Oncology News International, May, 1996,"Panel Recommende Hycamtin Approval for Ovarian Cancer".]