Novartis' Tasigna Superior Over Glivec In Ph+ CML
Novartis reported that data from its six-year pivotal study supported the superiority of its drug Tasigna (nilotinib) over its aging treatment Glivec (imatinib) in the treatment of newly-diagnosed patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML).
Tasigna is indicated for the treatment of chronic phase and accelerated phase Philadelphia chromosome-positive chronic myelogenous leukemia in adult patients who are resistant or intolerant to at least one prior therapy including Glivec. The drug is approved in over 85 countries for the treatment of the chronic phase of Ph+ CML. Glivec is approved in over 110 countries for the treatment of all phases of Ph+ CML along with other indications. Though Glivec generated $1 billion in sales in the third quarter of the year for Novartis, the aging drug is set to lose patent protection as early as 2015, according to Bloomberg.
In the ENESTnd trial, results showed that fewer patients under the Tasigna treatment arm compared to those taking Glivec had their disease progress to advanced stages, which is a key therapeutic goal in treating CML. Also, patients taking Tasigna experienced higher rates of early, deep, and sustained molecular response including MR4.5, a very low level of the culprit protein behind Ph+ CML known as BCR-ABL.
“At the ENESTnd six-year follow up, we still see consistent evidence of deeper molecular response and fewer progressions to advanced disease in patients taking Tasigna compared to those on Glivec. These data provide further evidence of the consistent clinical profile of Tasigna as a leading treatment in newly-diagnosed patients,” said Giuseppe Saglio, trial investigator and Professor of Internal Medicine and Hematology and Director of the Department of Molecular Medicine and Targeted Therapy, San Luigi University Hospital at the University of Turin in Orbassano, Italy.
Novartis presented the six-year update from its ENESTnd trial at the 56th annual meeting of the American Society of Hematology (ASH) in San Francisco.