will be administered to those patients whose cancer has not responded to chemotherapy treatment or has relapsed.
The leukemia therapeutics market last year was dominated by branded drugs such as Gleevec (imatinib), Tasigna, Clolar and Arranon
with a market share of 85%, while generics such as vincristine, doxorubicin, methotrexate and cytarabine accounted for the remaining 15% share.
Other GSK oncology assets highlighted at the seminar include Arranon for T-cell acute lymphoblastic leukemia and lymphoma (launch in Q106), new indications for Hycamtin in relapsed cervical and relapsed small cell lung cancer (filing Q405/2006), Avodart for reducing the risk of prostate cancer (phase III) and relacatib ('795) a cathepsin-K inhibitor for the prevention and treatment of bone metastases (entering phase II in 2006).
Arranon, Hycamtin, Avodart, Tykerb and Zofran are trademarks of the GlaxoSmithKline Group of companies.
To facilitate the development of ARRANON for this relatively small group of patients, GSK worked closely with the National Cancer Institute (NCI) of the National Institutes of Health (NIH), the Children's Oncology Group (COG) and the Cancer and Leukemia Group B (CALGB), in conjunction with the Southwest Oncology Group (SWOG).
ARRANON received accelerated approval, granted by the FDA to medicines for treating serious or life-threatening illnesses that address an unmet medical need, based on complete response rates demonstrated in two Phase II trials in patients who had exhausted standard treatment options.
As the first in a series of innovative medicines set to emerge from GSK's robust oncology pipeline over the next few years, ARRANON is an important milestone for our oncology business and provides a glimpse of our promise for the future.
GSK is seeking approval in the United States of Arranon for the treatment of T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in pediatric and adult patients whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens.
We are extremely pleased that the advisory committee has recommended the approval of Arranon," said Paolo Paoletti, M.
Discovered by GSK, Arranon is a water-soluble prodrug of ara-G with T-cell selectivity.