FDA Approves Pfizer's Leukemia Drug For Kids As Old As One Year

Zinger Key Points
  • In August 2017, the FDA approved Pfizer's Besponsa for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
  • Efficacy was evaluated in a multicenter, single-arm, open-label study in 53 pediatric patients.

Wednesday, the FDA approved Pfizer Inc’s PFE inotuzumab ozogamicin (Besponsa) for pediatric patients one year and older with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL).

Also Read: Pfizer’s Aggressive Stance In Obesity Drugs: CEO Albert Bourla Confirms Bold Bet Despite Prior Drug Hurdles.

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.

Read Next: Crucial Battle Over Healthcare Mandates: Biden Administration Defends Preventive Care Coverage Amidst Legal Challenges.

Photo via Shutterstock

Market News and Data brought to you by Benzinga APIs
Comments
Loading...
Posted In: BiotechLarge CapNewsHealth CareFDAGeneralBriefsStories That Matter
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!