FDA OKs expanded label for Pfizer’s antibody-drug conjugate Mylotarg

The FDA approves the use of Pfizer’s (PFE -0.6%) Mylotarg (gemtuzumab ozogamicin) for newly diagnosed CD33-positive acute myeloid leukemia (AML) patients as young as one month old.

The agency approved the antibody-drug conjugate in September 2017 for newly-diagnosed adults and relapsed/refractory patients at least two years old.

https://seekingalpha.com/news/3583479-fda-oks-expanded-label-for-pfizers-antibody-drug-conjugate-mylotarg