GlaxoSmithKline has received approval from US regulators to market an oral version of its oncology agent Hycamtin as a treatment for relapsed small cell lung cancer.
The US Food and Drug Administration has given the green light to Hycamtin (topotecan) capsules to be used by patients who had a complete or partial response to first-line chemotherapy and who are at least 45 days from the end of that treatment. The company noted that Hycamtin is the only oral single-agent chemotherapy approved for SCLC after failure of first-line therapy and it will begin selling the drug in 2008.
The approval was based on positive results from a Phase III study comparing Hycamtin plus best supportive care (treatments that improve comfort and quality of life for the patient, but are not intended to have any anti-tumour effects) to BSC alone in patients with relapsed SCLC, in addition to Phase II and Phase III supporting studies. In the pivotal Phase III trial, Hycamtin added to BSC was associated with prolonged survival in patients with relapsed SCLC.
Debasish Roychowdhury at GSK’s oncology medicine development centre, said that the approval is particularly important for patients with relapsed SCLC “as they now have an effective treatment option that has been shown to provide a survival benefit and can be conveniently taken at home”. This is a clear benefit given that Hycamtin delivered intravenously requires five consecutive days of therapy every three weeks.
The company said it has submitted registration dossiers for the capsules in Europe, Canada and other markets around the world. IV Hycamtin, which is a topoisomerase I inhibitor, is already sold in around 80 countries and is approved for SCLC-sensitive disease after failure of first-line chemotherapy and for the treatment of ovarian and cervical cancer.