Sprycel dasatinib regulatory update

The U.K.'s NICE issued draft guidance recommending against 3 drugs to treat chronic myelogenous leukemia (CML) in patients resistant to the standard 400 mg dose of Glivec imatinib from Novartis. The committee rebuffed Sprycel dasatinib from Bristol-Myers Squibb, Novartis' Tasigna nilotinib and the higher, 800 mg dose of Glivec. NICE CEO Andrew Dillon said the evidence for the effectiveness of the 3 drugs is "very weak." CML affects about 560 people in the U.K. each year, many of whom are treated by the standard Glivec dose. The deadline for comments is May 27, with a second appraisal committee meeting scheduled for June 9.

NICE said the cost of Sprycel and Tasigna is greater than £30,000 ($50,040) per patient per year, while high dose Glivec costs more than £40,000 ($66,720) per patient per year. Neither company has submitted a patient access scheme. ...