GlaxoSmithKline has received from the European Commission (EC) a marketing authorisation for Hycamtin (topotecan powder for concentrate for solution for infusion) 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.

According to a GSK release, Hycamtin is the first drug to be approved in Europe that is specifically indicated for the treatment of relapsed SCLC. Data from the Hycamtin clinical trials show that treatment with Hycamtin is associated with prolonged survival and quality of life compared to best supportive care in patients battling the disease.

The marketing authorisation follows a positive opinion in November 2005 by the European Committee for Human Medicinal Products (CHMP) for Hycamtin.

Hycamtin is a compound already familiar to oncologists as a treatment for relapsed ovarian cancer. The chemotherapeutic agent belongs to a class of drugs known as topoisomerase I (topo-I) inhibitors, and works by inducing DNA damage which results in the death of dividing cells. Because two thirds of patients with SCLC already have extensive disease at the time of diagnosis and nearly all patients with extensive disease eventually relapse, approval of Hycamtin is a significant step forward in widening options for patients.

"The oral form of Hycamtin has shown promising and unexpected results in improving symptoms and lengthening the life of patients with relapsed SCLC, a disease that is traditionally associated with a grave outlook for patients. This approval of intravenous Hycamtin will now provide physicians and our patients an important new treatment option in SCLC," said Dr. Mary O'Brien, head of the lung cancer unit, The Royal Marsden NHS Foundation Trust, UK.

"Hycamtin appears to provide greater symptom improvement than CAV. The regimen has no neurotoxicity and in a randomised study, SCLC patients experienced a significant improvement in breathing difficulties and anorexia," said Dr J. von Pawel, head, department of oncology, Asklepios Kliniken München-Gaunting, Germany and an investigator in the study.

"Hycamtin is an important step forward in terms of improving the quality of life for SCLC patients and essentially allows them to make the best use of the time they have left," added Pawel.

European approval was principally based on three key phase III studies.

"Hycamtin offers an important new therapeutic option for patients in Europe who are faced with managing this devastating disease. This approval is 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," said Andrew Witty, president, Pharmaceuticals Europe, GSK.

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 small cell lung cancer.

Globally the highest rates of lung cancer in men are found in Europe, especially eastern Europe, and North America. For women, the highest rates are found in North America and European countries such as Denmark, Hungary, Iceland and the UK.