Wednesday, the FDA approved Pfizer Inc’s (NYSE:PFE) inotuzumab ozogamicin (Besponsa) for pediatric patients one year and older with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL).
Efficacy was evaluated in a multicenter, single-arm, open-label study in 53 pediatric patients.
Two dose levels were evaluated: An initial dose of 1.4 mg/m2/cycle in 12 patients and 1.8 mg/m2/cycle in 41 patients.
The main efficacy outcome measures were complete remission (CR), duration of CR, and the proportion of patients with minimal residual disease (MRD) negative CR.
CR was defined as <5% blasts in the bone marrow and the absence of peripheral blood leukemia blasts, full recovery of peripheral blood counts (platelets ≥ 100 × 109 and ANC ≥1 × 109/L), and resolution of any extramedullary disease.
MRD was defined by leukemic cells comprising < 1 × 10-4 (<0.01%) of bone marrow nucleated cells by flow cytometry or by PCR.
In all patients, 22/53 achieved CR, and the median duration of CR was 8.2 months.
The MRD negativity rate in patients with CR was 21/22 based on flow cytometry and 19/22 based on RQ-PCR.
In August 2017, the FDA approved inotuzumab ozogamicin for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
Price Action: PFE shares are down 1.03% at $26.91 on the last check Thursday.
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