GlaxoSmithKline [NYSE: GSK] announced approval by the U.S. Food and Drug Administration (FDA) for oral Hycamtin ® (topotecan) capsules for the treatment of relapsed small cell lung cancer (SCLC).
Specifically, Hycamtin capsules are indicated for 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. Hycamtin capsules are the only oral single-agent chemotherapy approved for the treatment of SCLC after failure of first-line therapy. The product will be available in 2008.
“The approval of Hycamtin capsules is particularly important for patients with relapsed small cell lung cancer as they now have an effective treatment option that has been shown to provide a survival benefit and can be conveniently taken at home,” said Debasish Roychowdhury, M.D., Vice President, Global Clinical Development, Oncology Medicine Development Center, GSK. “Additionally, this milestone underscores GSK Oncology’s commitment to helping improve cancer patients’ quality of life.”
This approval was based on positive results from a Phase III study comparing Hycamtin capsules plus best supportive care (BSC) to BSC alone in patients with relapsed SCLC, in addition to Phase II and Phase III supporting studies. Best supportive care refers to treatments intended to control, prevent, and relieve disease complications to improve comfort and quality of life for the patient, but are not intended to have any anti-tumor effects.In the pivotal Phase III clinical trial, Hycamtin capsules added to BSC were associated with prolonged survival in patients with relapsed SCLC. This was the first randomized study ever to demonstrate that patients with relapsed SCLC live longer when they are treated with BSC and chemotherapy compared to BSC alone. Study results were published in the December 1, 2006 isue of the Journal of Clinical Oncology.1
“In clinical trials, Hycamtin capsules have shown the potential to benefit patients with SCLC, many of whom are prone to relapse,” said John Eckardt, M.D., Director of Clinical Research for the Center for Cancer Care and Research, St. Louis, MO. “The approval of Hycamtin capsules opens up new possibilitiesfor patients battling this disease and provides a convenient alternative to IV therapy.”