The positive opinion will now be proposed for final marketing approval by the European Commission. The product has previously received approval in Europe for the treatment of metastatic ovarian cancer after failure of first-line or subsequent therapy.
“Hycamtin offers clinicians an important therapeutic option for patients with relapsed SCLC (small cell lung cancer),” said Mikael von Euler, vice president of GSK’s Europe Oncology Medical Development Centre. “Hycamtin is an excellent example of GSK’s commitment to pursuing new therapeutic options for the compounds in its oncology portfolio.”
The positive European opinion was principally based on three key phase III studies. The first study compared the safety and efficacy of Hycamtin to the triple combination cyclophosphomide, doxorubicin and vincristine in patients with sensitive SCLC, with median overall survival being comparable between the two arms of the study.
The second study compared the safety and efficacy of an oral formulation of topotecan versus intravenous Hycamtin in patients with sensitive SCLC. Median overall survival was comparable between the two and both treatments were generally well tolerated.
The third Study was conducted to prove the survival benefit of second-line chemotherapy for relapsed SCLC patients. The study was conducted using oral Hycamtin plus best supportive care and compared safety and efficacy to best supportive care alone. Median overall survival for Hycamtin plus best supportive care was 25.9 weeks compared to 13.9 weeks for patients who received best supportive care alone.