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GlaxoSmithKline (GSK) announced that oral Hycamtin^™ (topotecan hard capsules) has received a positive opinion from the European Medicines Agency (EMEA) recommending marketing authorisation. GSK expects final approval by the European Commission and Marketing Authorisation for this indication in approximately two months. Topotecan capsules will be indicated as monotherapy for the treatment of adult patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate. ^[1]

Topotecan capsules once approved will be the first oral single-agent chemotherapy for the treatment of SCLC after failure of first-line therapy. The intravenous (IV) topotecan requires five consecutive days of IV therapy every three weeks, new topotecan capsules will provide physicians and patients with another, convenient option. The recommended dose of topotecan capsules is 2.3 mg/m² body surface area/day administered for five consecutive days with a three week interval between the start of each course.

“This positive opinion for topotecan capsules is a significant development for patients with relapsed small cell lung cancer across Europe. Topotecan capsules offer patients a convenient treatment option that has been shown to provide a survival benefit,” said Eddie Gray, President, Pharmaceuticals Europe, GlaxoSmithKline. “This approval is yet another example of GSK’s continued commitment to researching and developing an industry leading oncology portfolio to address the unmet medical needs of cancer patients around the world.”

Data submitted

The positive opinion was based on results from a Phase III study comparing topotecan capsules plus best supportive care (BSC)* to BSC alone in patients with relapsed SCLC, in addition to results from Phase II and Phase III supporting studies.

In the pivotal Phase III multicentre trial, 141 patients with relapsed SCLC not considered as candidates for standard IV therapy were randomised to receive BSC alone (n=70) or topotecan capsules plus BSC (n=71). Topotecan capsules added to BSC were associated with prolonged survival in patients with relapsed SCLC (p = 0.0104). Median overall survival for topotecan plus BSC was 25.9 weeks (95% CI, 18.3 to 31.6) compared to 13.9 weeks (95% CI, 11.1 to 18.6) for patients who received 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 topotecan capsules plus BSC compared with the patients who received BSC alone. ^[2]

The most common Grade 3 or 4 haematologic adverse reactions with topotecan capsules were neutropenia, anaemia, and thrombocytopenia. The most common (>10%) non-haematologic adverse reactions (all grades) were nausea, diarrhoea, vomiting, fatigue, and alopecia.²

Supporting studies submitted

Supportive efficacy and safety data were provided from a Phase II and a Phase III study, each of which compared topotecan capsules (oral) directly to topotecan (IV) in patients with relapsed sensitive SCLC.

In the Phase III study median survival time was 33.0 weeks (95% CI, 29.1 to 42.4 weeks) in the oral group and 35.0 weeks (95% CI, 31.0 to 37.4 weeks) in the IV group and both treatments were generally well-tolerated. ^[3] Safety data were presented for the three efficacy studies mentioned above and for an integrated relapsed lung cancer study population of 682 patients. The safety profile was consistent across all four studies.

About small cell lung cancer (SCLC) ^[4]

Lung cancer is the most common cancer in the world attributing to 13.2% of all cancer cases. About 20 out of every 100 cases diagnosed are SCLC. Of all those diagnosed with SCLC, around one in three have limited disease at the time of diagnosis. Two out of three already have extensive disease at the time of diagnosis. Of those who have limited disease and have chemotherapy, between 35 - 40% will be alive two years later. People with extensive disease are also treated with chemotherapy, but unfortunately the survival rate is even lower. Most only survive another ten to twelve months.

About Hycamtin

Hycamtin (topotecan) 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 topotecan results in damage to the cell’s cancerous genetic material and the death of dividing cancer cells.

GSK in oncology

GSK Oncology is dedicated to producing innovations in cancer that will make profound differences in the lives of patients. Through GSK’s revolutionary “bench to bedside” approach, we are transforming the way treatments are discovered and developed, resulting in one of the most robust pipelines in the oncology sector. Our worldwide research in oncology includes partnerships with more than 160 cancer centres. GSK is closing in on cancer from all sides with a new generation of patient focused cancer treatments in prevention, supportive care, chemotherapy and targeted therapies.

About GlaxoSmithKline

GlaxoSmithKline – one of the world's leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better, and live longer. For company information, visit GlaxoSmithKline at www.gsk.com.

To access the latest GSK Oncology media materials, visit www.gskcancermedia.com

Notes to editors:

Hycamtin ^® is the trademark of the GlaxoSmithKline group of companies.

Enquiries:

 

UK Media enquiries:	Philip Thomson	(020) 8047 5502
	Claire Brough	(020) 8047 5502
	Alice Hunt	(020) 8047 5502
	Joss Mathieson	(020) 8047 5502
European Analyst/Investor enquiries:	David Mawdsley	(020) 8047 5564
	Sally Ferguson	(020) 8047 5543

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