GlaxoSmithKline (GSK) announced that HYCAMTIN(R) (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. 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 Europefor 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," said Mikael von Euler, Vice President Europe Oncology Medical Development Centre, GSK. "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 (protocol 090) compared the safety and efficacy of HYCAMTIN to the triple combination cyclophosphomide, doxorubicin and vincristine (CAV) in patients with sensitive SCLC. Median overall survival was comparable between the two arms of the study (25.0 versus 24.7 weeks, p = 0.80).

The second Study (protocol 396) compared the safety and efficacy of an oral formulation of topotecan versus IV HYCAMTIN in patients with sensitive SCLC. Median overall survival was comparable between the two arms (33.0 versus 35.0 weeks, Hazard Ratio = 0.98) and both treatments were generally well-tolerated.

The third Study (protocol 478) 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. Median overall survival for HYCAMTIN(R) plus BSC was 25.9 weeks compared to 13.9 weeks for patients who received BSC alone (p = 0.01).

"These studies demonstrate that single-agent HYCAMTIN is active in relapsed SCLC." said Mikael von Euler. "Furthermore, the HYCAMTIN versus best supportive care study (protocol 478) has proven for the first time that treatment of relapsed SCLC in appropriate patients can offer symptom as well as survival benefit."

About Small Cell Lung Cancer

Lung cancer is the leading cause of cancer-related death in the world. Small cell lung cancer accounts for 15 to 18 percent of all cases and is among the most aggressive of all pulmonary tumors.

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.

About HYCAMTIN(R)

HYCAMTIN(topotecan HCl for Injection) is a chemotherapeutic agent that belongs to a class of drugs known as topoisomerase I (topo-I) inhibitors. Topo-I is an enzyme essential for the replication of DNA, and therefore cell division, in both normal and cancer cells. Interaction between topo-I and HYCAMTIN results in damage to the cell's genetic material and the death of dividing cancer cells.

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. In addition HYCAMTIN is registered for the treatment of sensitive relapsed small cell lung cancer (SCLC) in 39 countries worldwide. More than 230,000 patients have been treated with HYCAMTIN since its launch in 1996. More information on HYCAMTINcan be found at emea.eu.int.

Important Safety Information

HYCAMTINcan suppress the body's ability to produce blood cells, in particular the white blood cells which fight infection. This condition is known as neutropenia. The clotting elements (platelets) can also be decreased, a condition known as thrombocytopenia. HYCAMTIN is contraindicated in patients who have a history of hypersensitivity reactions to topotecan or any of its ingredients. HYCAMTIN should not be used in patients who are pregnant or breast-feeding, or in those with severe bone marrow depression.

About GlaxoSmithKline

GlaxoSmithKline (NYSE: GSK) is one of the world's leading research-based pharmaceutical and healthcare companies. GlaxoSmithKline is committed to improving the quality of human life by enabling cancer patients to do more, feel better and live longer. For more information, visit gsk.

References:

1. O'Brien MER, Ciuleanu T, Tsekov H, et. al. An open-label, multicenter, randomized, phase III comparator study of supportive care alone or in combination with oral topotecan in patients with relapsed resistant small-cell lung cancer. In press.

2. Maghfoor I. Lung cancer. www.emedicine. Accessed 10/6/05.

3. National Cancer Institute. wwwncer. Accessed 11/8/05

4. Jemal A, Murray T, Samuels A, et al. Cancer statistics. CA Cancer J Clin 2003 ; 53 : 5-26.

5. Janssen-Heijnen ML, Coebergh JW. The changing epidemiology of lung cancer in Europe. Lung Cancer 2003; 41: 245-58.

6. von Pawell J. Topotecan versus cyclophosphamide, doxorubicin, and vincristine for the treatment of recurrent small-cell lung cancer. J Clin Oncol. 1999 Feb;17(2):658-67

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