April 12, 2008-GlaxoSmithKline (GSK) announced that oral Hycamtin® (topotecan hard capsules) have received approval from the European Commission for the treatment of relapsed SCLC. Specifically, topotecan hard capsules are indicated as monotherapy for the treatment of adult patients with relapsed SCLC (PS0-2 ) for whom re-treatment with the first-line regimen is not considered appropriate.
Topotecan is already available as an intravenous (IV) injection and the approval of topotecan hard capsules provides physicians and patients with another convenient option.
“The approval of topotecan hard capsules is welcome news for patients and their physicians. Small cell lung cancer is a very aggressive disease and there are limited treatment options after relapse,” said Dr. Mary O'Brien, Head of the Lung Cancer Unit at The Royal Marsden Hospital, Surrey, UK. “Topotecan not only improves symptoms and extends the lives of patients, but as it is in capsule form treatment can be started without delay.”
“The European approval of topotecan as an oral formulation is good news for patients with relapsed small cell lung cancer across Europe. Topotecan hard capsules provide physicians and patients with an alternative, effective treatment, with the added convenience of being administered orally,” said Eddie Gray, President, Pharmaceuticals Europe, GlaxoSmithKline. “The approval of topotecan capsules continues to underscore GSK’s commitment to the research and development of therapies to address the unmet medical needs of cancer patients around the world.”
The details can be read here.
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