Bristol-Myers Squibb wins Canadian approval for lower dose leukemia drug

Previously these patients began Sprycel therapy with a dose of 70mg taken twice daily. The once a day dosing simplifies treatment for patients and the lower dose offers less side effects while preserving efficacy of the higher twice daily dose, the company said.

The conditional approval of the new lower starting dose was based on data from a Phase III dose-optimization study in chronic phase chronic myeloid leukemia (CML) patients whose disease was resistant or intolerant to imatinib mesylate (marketed as Gleevec).

According to the company, the lower Sprycel 100mg once daily retained the efficacy of conventional 70mg twice daily and was associated with consistently lower frequency of adverse events including a marked reduction of the incidence of pleural effusions and haematologic complications. Additionally, there were significantly fewer dose interruptions and discontinuations at 100mg once daily.

Jeff Lipton, medical oncologist and associate professor of medicine at the University of Toronto, said: The lower starting dose for Sprycel, combined with the convenience of once daily dosing makes it easier for patients to comply with the prescribed regimen. This is good news from a clinician perspective, because what it provides us with is a lower dose of the drug with less side effects without compromising efficacy.