GSK Receives Approval for HYCAMTIN(R) (topotecan) Capsules

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GSK Receives Approval for HYCAMTIN® (topotecan) Capsules for the Treatment of Relapsed Small Cell Lung Cancer

First FDA Approved Oral Therapy Will Allow Patients to be Treated for This Aggressive Cancer at Home

October 15, 2007: 08:45 AM EST

PHILADELPHIA, Oct. 15 /PRNewswire-USNewswire/ -- GlaxoSmithKline announced today 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 issue 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 possibilities for patients battling this disease and provides a convenient alternative to IV therapy."

HYCAMTIN Capsules Clinical Trial Results(1,2)

In the Phase III multicenter trial, 141 patients with relapsed SCLC not considered as candidates for standard IV therapy were randomized to receive BSC alone (n = 70) or HYCAMTIN capsules (2.3 mg/m2/day, days 1 through 5, every 21 days) plus BSC (HYCAMTIN capsules; n = 71). The primary objective was to compare overall survival between the two treatment arms. Patients who received HYCAMTIN capsules plus BSC showed a statistically significant improvement in overall survival compared with the patients who received BSC alone (Log-rank p = 0.0104). Median survival with HYCAMTIN capsules plus BSC was 25.9 weeks (95% CI, 18.3 to 31.6) and was 13.9 weeks (95% CI, 11.1 to 18.6) with BSC alone. The hazard ratio was 0.64 (95% C.I: 0.45, 0.90), indicating a 36% reduction in the risk of death for patients who received HYCAMTIN capsules plus BSC compared with the patients who received BSC alone.(1)

The most common Grade 3 or 4 hematologic adverse reactions with HYCAMTIN capsules were neutropenia (61%), anemia (25%) and thrombocytopenia (37%). The most common (>10%) non-hematologic adverse reactions (all grades) were nausea (27%), diarrhea (14%), vomiting (19%), fatigue (11%) and alopecia (10%).(2)

About Small Cell Lung Cancer (SCLC)(3)

SCLC is caused by an uncontrolled growth of cells beginning on the surface of the lung's breathing tubes (called bronchi) and tends to spread widely through the body. This is important because it means that surgery is rarely used as a treatment option. Chemotherapy is the most common treatment for SCLC. Although SCLC is often responsive to first-line treatments, patients may relapse.

SCLC is most common in current or past smokers, but can also be caused by environmental risk factors such as exposure to radon and air pollution. About 15% of patients with lung cancer have SCLC, a fast-growing form of the disease.

About HYCAMTIN® Capsules

HYCAMTIN capsules belong to a class of drugs known as topoisomerase I (topo-I) inhibitors. Topo-I is a naturally produced protein essential for cell division in both normal and cancer cells. Interaction between topo-I and HYCAMTIN capsules results in permanent damage to the cell's genetic material and the death of dividing cells. Registration dossiers for HYCAMTIN capsules have been submitted in Europe, Canada and other markets around the world.

Important Safety Information

HYCAMTIN capsules can suppress the body's ability to produce disease fighting white blood cells, a condition known as neutropenia. In addition, the amount of clotting cells can decrease (thrombocytopenia). Generally, HYCAMTIN capsules have a mild to moderate non-hematologic toxicity profile. Other common side effects include nausea, vomiting, diarrhea and hair loss (alopecia).