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European Commission Approves IV Hycamtin (Topotecan Powder for Concentrate for Solution for Infusion) for Relapsed Small Cell Lung Cancer

By Jill Stein

LONDON, UK -- February 1, 2006 -- The European Commission has approved Hycamtin® (topotecan powder for concentrate for solution for infusion) for use as a treatment for patients with relapsed small cell lung cancer (SCLC) in whom repeat treatment with the first-line regimen is not considered appropriate, GlaxoSmithKline (GSK) announced today.

Hycamtin is the first agent to be approved in Europe that is specifically indicated for the treatment of relapsed SCLC. Its approval for this new indication was anticipated following a positive opinion in November by the European Committee for Human Medicinal Products (CHMP).

The agent is already approved for relapsed ovarian cancer following the failure of platinum-based therapy.

Hycamtin is the first in a class of drugs known as topoisomerase I inhibitors which kill cancer cells by inhibiting the enzyme topoisomerase I, which is essential in the replication of DNA in human cells.

"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," Mary O'Brien, MD, Head of the Lung Cancer Unit, The Royal Marsden NHS Foundation Trust, London, UK, said in a news release. "This approval of intravenous Hycamtin will now provide physicians and our patients an important new treatment option in SCLC."

The compound's approval was issued on the basis of three pivotal phase III trials:

* The first study (protocol 090) found that the median overall survival was comparable between Hycamtin ® and the triple combination cyclophosphomide, doxorubicin and vincristine (CAV) in patients with sensitive SCLC (25.0 weeks versus 24.7 weeks, P =.80). Hycamtin-treated patients experienced a significant improvement in breathing difficulties and anorexia.

* The second study (protocol 396) found that the median overall survival was comparable between an oral formulation of topotecan and IV Hycamtin in patients with sensitive SCLC (33.0 weeks versus 35.0 weeks, HR = 0.98). 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 plus BSC was 25.9 weeks versus 13.9 weeks for patients who received BSC alone (P =.01).

Small cell lung cancer is the most aggressive form of lung cancer and is responsible for about a fourth of all lung cancer diagnoses. Roughly two -thirds of patients with SCLC already have extensive disease at the time of diagnosis, and nearly all patients with extensive disease eventually relapse.


SOURCE: GlaxoSmithKline

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