Small Business Warning Letter



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Background According to its FDA-approved product labeling (PI): Dacogen is indicated for the treatment of patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and Intermediate-1, Intermediate-2, and High-Risk International Prognostic System groups.. The DOSAGE AND ADMINISTRATION section of the PI states (in pertinent part): Dose Adjustment or Delay Based on Hematology Laboratory Values If hematologic recovery (ANC ≥ 1,000/μL and platelets ≥ 50,000/μL) from a previous Dacogen treatment cycle requires more than 6 weeks, then the next cycle of Dacogen therapy should be delayed and dosing temporarily reduced by following this algorithm: • Recovery requiring more than 6, but less than 8 weeks - Dacogen dosing to be delayed for up to 2 weeks and the dose temporarily reduced to 11 mg/m2 every 8 hours (33 mg/m2/day, 99 mg/m2/cycle) upon restarting therapy.. The card also includes the following claim and presentation: • “DACOGEN PROVIDES BENEFIT IN RAEB-T PATIENTS”1,6 (“Gil”) in conjunction with: o A graph that shows a 54 “Clinical benefit (stable disease or better),” and an 18 “Complete or partial response rate” for these patients (N=17) o A footnote that defines “stable disease” as “failure to achieve at least a PR but with no evidence of progression for at least 2 months.” o A footnote that defines “clinical benefit” as “patients achieving complete response (CR) + partial response (PR) + hematological improvement (HI described by magnitude of response major or minor and individual responsive cell lines) + stable disease (SD)” (footnote omitted) These claims regarding the efficacy of Dacogen in RAEB-T patients are not substantiated.. As stated in the PI, in the Phase 3 trial, “ s

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