Tasigna continues to surpass Glivec as a treatment for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase, according to a statement issued by Novartis today. The Swiss drugmaker makes both drugs, but, as Bloomberg notes, Glivec loses patent protection as early as 2015.
According to 24-month study data, first-line treatment with Tasigna at 300 mg twice daily was found to result in a lower incidence of progression to the accelerated phase of the disease compared with the standard approved dose of Glivec 400 mg once daily. The FDA and Swissmedic have approved Tasigna in the first-line indication. Regulatory submissions are under review in the European Union, Japan and other countries worldwide.
"These 24-month Phase III data extend the evidence of clinical benefit for newly diagnosed patients with chronic phase Ph+ CML treated with Tasigna, compared to Glivec," said Timothy Hughes, MD, ENESTnd study investigator and Clinical Professor at the University of Adelaide, Australia. "Now we can begin to evaluate the long-term treatment outcomes of patients who achieve and maintain deep reductions in Bcr-Abl on Tasigna."
This year, Novartis also began a collaboration with molecular diagnostics company Cepheid to develop a new FDA cleared/approved Bcr-Abl test. The goal of the collaboration is to help doctors more reliably monitor Ph+ CML patients. Cepheid and Novartis also will develop a next generation test to enable even more sensitive testing.
Novartis oncology chief Herve Hoppenot told Reuters recently that Tasigna had been gaining market share in the second-line setting very quickly, even though it came to market after Bristol-Myers Squibb's rival drug Sprycel.