Taxol Cleared For First-Line Use In Ovarian Cancer

Bristol-Myers Squibb has been granted approval in the UK to market its anticancer drug Taxol (paclitaxel) for first-line treatment, in combination with cisplatin, of women with ovarian cancer. This is the first time that approval has been granted for first-line use of Taxol in these patients, although it is thought that many oncologists, at least in the USA, are already using the drug off-label for this indication.

The approval follows the completion of the GOG-111 study, data from which were first reported three years ago (Marketletter October 25, 1993) which showed that the combination can prolong survival by more than 50% compared to standard chemotherapy. A spokesman for the company told the Marketletter that the new indication is expected to roll out across Europe in the next few months, but that B-MS has not filed for approval for first-line use in the USA.

Commenting on the new approval, Richard Osborne, consultant in medical oncology at Dorset Cancer Centre in the UK, said "for selected patients with advanced ovarian cancer embarking on first-line chemotherapy, currently available data show an improvement in survival when Taxol is added to standard treatment." He added that GOG-111 showed that the median survival of women taking the combination of paclitaxel and cisplatin was 38 months, compared to 24 months for cisplatin plus cyclophosphamide.