UK drug major GlaxoSmithKline has won approval for its cancer drug Hycamtin as a treatment for cervical cancer in the USA, the first time that a drug regimen has been cleared for late-stage disease.
Hycamtin (topotecan), a topoisomerase I inhibitor, was cleared by the US Food and Drug Administration for use in combination with cisplatin in the treatment of advanced, recurrent, or persistent carcinoma of the cervix which has not responded to treatment with surgery and/or radiation therapy.
There are an estimated 10,000 new cases of cervical cancer and about 3,700 related deaths each year in the USA.
Following a six-month priority review by the FDA, the expanded indication is based on Phase III results that demonstrate a survival advantage for Hycamtin in combination with cisplatin versus cisplatin alone. Patients in the trial showed a statistically-significant improvement in overall survival with Hycamtin and cisplatin. Median survival for the combination group was 9.4 months versus 6.5 months for cisplatin alone.
Hycamtin has already been cleared in the USA for treating ovarian cancer and small cell lung cancer, and is one of GSK’s top-selling cancer drugs, bringing in sales of £99 million last year ($183m).
But even with the expanded label, Hycamtin is likely to remain a niche product for GSK, with other drugs in its pipeline, notably Tykerb (lapatanib) for breast cancer, expected to elevate the company’s oncology franchise into the major leagues.
Eltrombopag helps patients with platelet disorder
Meanwhile, GSK had good news for another product with applications in oncology, the platelet growth factor eltrombopag, in patients suffering from the haematological disorder idiopathic thrombocytopenic purpura.
Results of a Phase II study presented at the European Society of Haematlogy annual meeting in Amsterdam this morning revealed that the orally-active drug boosted platelet counts in 70% to 81% of ITP patients, depending on the dose used, after six weeks of treatment. With placebo only 11% of patients achieved this response.
ITP is characterised by low platelet counts leaving patients at risk of episodes of spontaneous bruising, mucosal bleeding, and in severe cases intracranial haemorrhage. Eltrombopag is currently in Phase III trials for the condition, and GSK is expecting to file for marketing approval of the drug in 2006 or 2007.
Eltrombopag is also in development at GSK to help cancer patients manage the side effects of chemotherapy, which can include low platelet counts.