ROCKVILLE, MarylandFDA has granted priority review for GlaxoSmithKline's new drug application (NDA) for Oral Hycamtin (topotecan) capsules for the treatment of relapsed small-cell lung cancer (SCLC). The NDA was based on results from a phase III study comparing Oral Hycamtin plus best supportive care (BSC) to BSC alone in patients with relapsed SCLC (O'Brien M et al: J Clin Oncology 24:5441-5447, 2006).
Unlike IV Hycamtin, which requires 5 consecutive days of intravenous therapy every 3 weeks, Oral Hycamtin allows patients to be treated at home.
In the phase III multicenter trial, 141 patients with relapsed SCLC not considered as candidates for standard IV therapy were randomized to receive BSC alone or Oral Hycamtin (2.3 mg/m2/d on days 1 to 5 every 21 days) plus BSC. Median overall survival with Oral Hycamtin/BSC was 25.9 weeks vs 13.9 weeks with BSC alone (P = .0104).