The intravenous formulation of GlaxoSmithKline’s Hycamtin has become the first drug in Europe to be approved for patients with small cell lung cancer who relapse after first-line treatment.
Hycamtin (topotecan) is already approved for the second-line treatment of advanced ovarian cancer.
The latest approval is based on three clinical studies which showed that it prolonged survival and quality of life compared to best supportive care in these patients.
The first compared Hycamtin to a triple regimen of conventional therapy (cyclophosphomide, doxorubicin and vincristine or CAV) in patients with sensitive SCLC and found both arms comparable in terms of overall survival. The second trial evaluated oral Hycamtin with an intravenous form of the drug, and again found that the two treatment groups were comparable in terms of overall survival and tolerability.
Finally, the third study was designed to investigate the survival benefit of second-line chemotherapy for relapsed patients, using oral Hycamtin plus best supportive care versus the latter alone. Overall survival was 26 weeks amongst patients given GSK's drug, compared to 14 weeks in those receiving best supportive care.
Analysts said the new indication would give Hycamtin a boost, but would not impart a huge amount of momentum to sales growth for the product, which brought in $74 million in revenues for the first nine months of 2005.