SB's Hycamtin Backed By US Committee
The US Food and Drug Administration's Oncologic Drugs Advisory Committee has recommended approval of SmithKline Beecham's Hycamtin (topotecan hydrochloride), the first topoisomerase I inhibitor to be reviewed in the USA, for the second-line treatment of metastatic ovarian cancer.
The other major player in this new class of anticancer drugs, Pharmacia & Upjohn's Camptosar (irinotecan), has been filed for approval in the USA but has not come up against the advisory committee. This drug, originally developed by Yakult Honsha of Japan, is also licensed to Rhone-Poulenc Rorer, which has launched it in several countries worldwide.
The Committee's favorable recommendation was based on the results of two large clinical trials, 039 and 034, in which Hycamtin was used to treat patients with recurrent ovarian cancer. In each study, the dosage of Hycamtin was 1.5mg/m2 administered intravenously over 30 minutes daily for five days and repeated every 21 days.
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