Hycamtin is currently indicated for the treatment of metastatic ovarian cancer after failure of initial or subsequent chemotherapy, and for the treatment of small cell lung cancer after failure of first-line therapy.
The application is based on results from a randomized, multicenter phase III trial, designed and conducted by the Gynecologic Oncology Group. The trial demonstrated a survival advantage with the use of Hycamtin in combination with cisplatin compared to cisplatin alone.
According to the company, cervical cancer is the third most common gynecological cancer among American women, with close to 12,000 new cases diagnosed annually. “Prognosis is positive if the disease is discovered early; however, expectations drop dramatically for those patients with advanced stage disease,” explains Kevin Lokay, vice president of oncology and acute care at GSK.