SPRYCEL receives FDA approval for treating adult patients with Ph+ CML in chronic phase

After receiving a priority review, Bristol-Myers Squibb Company (NYSE:BMY) and Otsuka Pharmaceutical Co., Ltd. today announced that the U.S. 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 leukemia (CML) in chronic phase. The trial is ongoing and further data will be required to determine long-term outcome.

“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”

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, M.D., Ph.D., 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%), hemorrhage (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 2 hours before or after SPRYCEL. Tablets should not be crushed or cut; they should be swallowed whole. Please read the Important Safety Information section, including information on Drug Interactions, below.

SPRYCEL Demonstrated Superior Response Rates Compared to imatinib

In the DASISION study, SPRYCEL demonstrated superior efficacy with higher and faster molecular and confirmed cytogenetic response rates compared to imatinib by 12 months in newly diagnosed CP-CML patients. Seventy-seven percent [95% CI: 71.2 - 81.8] of SPRYCEL patients vs. 66% [95% CI: 60.1 - 71.9] of imatinib patients achieved the primary endpoint of confirmed CCyR (two consecutive assessments of CCyR at least 28 days apart) by 12 months> Median time to confirmed CCyR was 3.1 months in 199 SPRYCEL responders and 5.6 months in 177 imatinib responders. Median time to major molecular response (MMR) was 6.3 months in 135 SPRYCEL responders and 9.2 months in 88 imatinib responders. MMR at anytime was higher for SPRYCEL patients (52% [95% CI: 45.9 - 58.3]) versus imatinib (34% [95% CI: 28.1 - 39.9]), p<0.0001. Transformation to accelerated or blast phase occurred in 5 patients receiving SPRYCEL and 9 patients receiving imatinib.

In this study, the most frequently reported serious adverse reactions included pleural effusion (2%), hemorrhage (2%), congestive heart failure (1%), and pyrexia (1%). The most frequently reported adverse reactions reported in ≥10% of SPRYCEL patients included myelosuppression, fluid retention events (pleural effusion, superficial localized edema, generalized edema), diarrhea, headache, musculoskeletal pain, and rash. In patients receiving SPRYCEL, pleural effusion (all grades) was reported in 12%; Grade 3 and 4 pleural effusion was reported in <1% of patients. Severe pleural effusion may require thoracentesis and oxygen therapy. Fluid retention events were typically managed by supportive care measures that include diuretics or short courses of steroids.

Source: Bristol-Myers Squibb Company

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