First Approval Of SB's Hycamtin

SmithKline Beecham's topoisomerase I inhibitor Hycamtin (topotecan) has been approved for the second-line treatment of recurrent ovarian cancer in the USA. This is the first approval for the drug worldwide, and the first time that a topo I inhibitor has been cleared in the USA.

SB says it will launch the product "within the next few weeks." Clinical trials submitted in support of the application indicate that Hycamtin can achieve higher response rates in ovarian cancer than Bristol-Myers Squibb's much-acclaimed Taxol (paclitaxel), as well as significantly longer progression-free survival.

Hycamtin is also being studied as a single-agent or in combination for a number of other tumor types including small cell lung, breast and colorectal cancers, and as a first-line agent in ovarian cancer. It has been filed in all major markets worldwide.