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 (Taxol) and a numerically superior response
[For a more detailed discussion of the pivotal trials, see Oncology
News International, May, 1996,"Panel Recommende Hycamtin
Approval for Ovarian Cancer".]