After receiving a priority review, Bristol-Myers Squibb Company (BMS) and Otsuka Pharmaceutical Co, Ltd announced that the US Food and Drug Administration (FDA) has approved Sprycel (dasatinib) 100 mg once daily for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukaemia (CML) in chronic phase. The trial is ongoing and further data will be required to determine long-term outcome.

The approval was based on results from the DASISION (Dasatinib versus Imatinib Study in Treatment-Naïve CP-CML Patients) open-label, phase-3 trial, which were published in the New England Journal of Medicine and presented as a late-breaking abstract at the 46th Annual Meeting of the American Society of Clinical Oncology in June 2010.

“Data from the DASISION trial demonstrated that newly diagnosed patients with Ph+ CML in chronic phase who received Sprycel attained higher and faster molecular and confirmed complete cytogenetic response rates by 12 months compared to imatinib,” said Elliott Sigal, executive vice president, chief scientific officer, and president, Research & Development, Bristol-Myers Squibb. “The FDA approval of Sprycel as a first-line treatment for chronic phase CML builds on our commitment to advancing care in hematologic malignancies. Patients now have an option that has both improved response over imatinib, the current standard of care, and offers a once-daily dosing convenience with no fasting requirements.”

In the DASISION study, the most frequently reported serious adverse reactions included pleural effusion (2%), haemorrhage (2%), congestive heart failure (1%), and pyrexia (1%). Sprycel is associated with drug interactions, including use of concomitant strong CYP3A4 inducers, which may decrease plasma concentrations of Sprycel and should be avoided. Strong CYP3A4 inhibitors and grapefruit juice may increase plasma concentrations of Sprycel and should be avoided. The concomitant use of H2 antagonists or proton pump inhibitors with Sprycel is not recommended. The use of antacids should be considered in place of H2 antagonists or proton pump inhibitors in patients receiving Sprycel therapy. The antacid dose should be given two hours before or after Sprycel. Tablets should not be crushed or cut; they should be swallowed whole.

DASISION (Dasatinib versus Imatinib Study in Treatment-Naïve CP-CML Patients) is an open-label, randomized, phase-3 international trial of Sprycel 100 mg taken once daily vs. imatinib 400 mg taken once daily, in the treatment of newly diagnosed chronic phase Ph+ CML.

Discovered and developed by Bristol-Myers Squibb, Sprycel initially received accelerated FDA approval in June 2006 as a treatment for adults for all phases of Ph+ CML (chronic, accelerated, or myeloid or lymphoid blast phase) with resistance or intolerance to prior therapy including Gleevec.