GlaxoSmithKlines’ Hycamtin (topotecan powder for concentration for solution for infusion) received positive opinion from the European Committee for Human Medicinal Products (CHMP) for the treatment of patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate.
According to the GSK release, Hycamtin is the first drug to receive a positive opinion from the CHMP for the treatment of relapsed SCLC. The CHMP's positive opinion will now be proposed for final marketing approval by the European Commission. The product 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. It is an excellent example of GSK’s commitment to pursuing new therapeutic options for the compounds in its oncology portfolio,” said Mikael von Euler, vice president, Europe Oncology Medical Development Centre, GSK
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 (CAV) in patients with sensitive SCLC. The second study compared the safety and efficacy of an oral formulation of topotecan versus IV Hycamtin in patients with sensitive SCLC.
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 (BSC) alone.
“These studies demonstrate that single-agent Hycamtin is active in relapsed SCLC.” said Mikael von Euler. “Furthermore, the Hycamtin versus best supportive care study has proven for the first time that treatment of relapsed SCLC in appropriate patients can offer symptom as well as survival benefit.”
Lung cancer is the leading cause of cancer-related death in the world. Small cell lung cancer accounts for 15 to 18 per cent of all cases and is among the most aggressive of all pulmonary tumours. An estimated 40,000 patients within the EU die of SCLC every year. The natural course of untreated SCLC results in a median survival time of 8 to 16 weeks.
Hycamtin (topotecan HCl for injection) is a chemotherapeutic agent that belongs to a class of drugs known as topoisomerase I (topo-I) inhibitors.
Hycamtin is registered in the European Union (EU), and 59 other countries around the world for the treatment of relapsed ovarian cancer following platinum-based therapy.